Diabetes Mellitus Type 2Phase 3NCT01042769
A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus
A Phase 3 study testing Aleglitazar in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 810 sites in 27 countries.
Trial summary
This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Aleglitazar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7,226 participants
- Where
- 810 sitesin 27 countries
- Study dates
- Feb 2010to Nov 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults >18 years of age
- Type 2 diabetes mellitus
- Hospitalization for ACS event and randomization between hospital discharge and 8 weeks after the ACS index event (day of hospitalization)
Who cannot join
- Estimated glomerular filtration rate <45 mL/min/1.73m2
- Concomitant treatment with a thiazolidinedione and/or fibrate
- Triglycerides >400 mg/dL
- Anaemia
- Symptomatic congestive heart failure classified as New York Heart Association (NYHA) class II-IV (France and Germany: Symptomatic congestive heart failure classified as NYHA class I-IV)
Trial locations and contacts
810 sites in 27 countries.
810 sites in 27 countries
United States221 sites
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Albany, New York, 12206-1098
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Albany, New York, 12211
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Albuquerque, New Mexico, 87102
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Albuquerque, New Mexico, 87131
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Alexandria, Louisiana, 71301
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Alpena, Michigan, 49707
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Amarillo, Texas, 79106
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Ames, Iowa, 50010
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Anaheim, California, 92801
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Ann Arbor, Michigan, 48106
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Annapolis, Maryland, 21401
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Atlanta, Georgia, 30312
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Austin, Texas, 78705
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Aventura, Florida, 33180
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Baltimore, Maryland, 21201
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Baltimore, Maryland, 21236
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Bangor, Maine, 04401
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Banning, California, 92220
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Bay City, Michigan, 48708
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Bellaire, Texas, 77401
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Beloit, Wisconsin, 53511
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Birmingham, Alabama, 35209
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Birmingham, Alabama, 35294
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Boston, Massachusetts, 02114
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Boston, Massachusetts, 02215
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Boynton Beach, Florida, 33472
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Bridgeport, Connecticut, 06606
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Bridgewater, New Jersey, 08807
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Brooklyn, New York, 11215
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Buffalo, New York, 14215
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Burlington, Wisconsin, 53105
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Canton, Ohio, 44708
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Carmichael, California, 95608
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Chambersburg, Pennsylvania, 17201
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Charlotte, North Carolina, 28204
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Chesterfield, Missouri, 63017
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Cincinnati, Ohio, 45219
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Cincinnati, Ohio, 45224
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Clearwater, Florida, 33756
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Cleveland, Ohio, 44106
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Colorado Springs, Colorado, 80909
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Columbia, Maryland, 21044
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Columbus, Ohio, 43201
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Columbus, Ohio, 43221
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Convington, Louisiana, 70433
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Coral Springs, Florida, 33065
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Council Bluffs, Iowa, 51501
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Dallas, Texas, 75216
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Dallas, Texas, 75230
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Dallas, Texas, 75231
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Dallas, Texas, 75390-9063
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Danville, Pennsylvania, 17822
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Danville, Virginia, 24541
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Davenport, Iowa, 52803
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Dayton, Ohio, 45428
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Decatur, Georgia, 30033
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Denver, Colorado, 80218
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Denver, Colorado, 80220
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Des Moines, Iowa, 50314
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Doral, Florida, 33166
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Durham, North Carolina, 27704
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Durham, North Carolina, 27710
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Edgewater, Florida, 32141
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Elizabeth, Florida, 07202
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Elizabethtown, Kentucky, 42701
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Elkhart, Indiana, 46514
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Fall River, Massachusetts, 02720
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Flint, Michigan, 48423
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Fort Lauderdale, Florida, 33316
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Freemont, Nebraska, 68025
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Fresno, California, 93720
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Fullerton, California, 92835
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Gainesville, Florida, 32608
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Glendale, California, 91204
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Grapevine, Texas, 76051
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Great Falls, Montana, 59405
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Green Bay, Wisconsin, 54301
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Greenville, North Carolina, 27834
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Greer, South Carolina, 29651
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Gurnee, Illinois, 60031
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Hammond, Louisiana, 70403
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Harrisburg, Pennsylvania, 17112
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Hartford, Connecticut, 06102
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Hawaiian Gardens, California, 90716
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Hialeah, Florida, 33010
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Hollywood, Florida, 33021
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Houma, Louisiana, 70360
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Houston, Texas, 77002
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Houston, Texas, 77024
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Houston, Texas, 77030
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Houston, Texas, 77075
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Houston, Texas, 77090
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Huntington, West Virginia, 25701
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Hyannis, Massachusetts, 02601
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Indianapolis, Indiana, 46260
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Inglewood, California, 90301
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Jackson, Mississippi, 39216
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Jacksonville Beach, Florida, 32250
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Johnson City, Tennessee, 37604
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Kalamazoo, Michigan, 49048
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Kerrville, Texas, 78028
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Kettering, Ohio, 45429
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Kingsport, Tennessee, 37660
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Kingwood, Texas, 77339
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La Crosse, Wisconsin, 54601-4795
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Lafayette, Indiana, 47905
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Lafayette, Louisiana, 70508
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Laguna Hills, California, 92653
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Lansing, Michigan, 48910
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Laplace, Louisiana, 70068
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Las Vegas, Nevada, 89102
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Layton, Utah, 84041
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Lexington, Tennessee, 38351
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Long Beach, California, 90822
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Los Angeles, California, 90033
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Lubbock, Texas, 79410
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Macon, Georgia, 31201
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Marion, Ohio, 43302
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Melbourne, Florida, 32901
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Mesa, Arizona, 85206
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Metarie, Louisiana, 70002
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Miami, Florida, 33136
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Miami, Florida, 33173
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Middleburg Heights, Ohio, 44130
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Milwaukee, Wisconsin, 53215
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Milwaukee, Wisconsin, 53295
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Mine Hill, New Jersey, 07803
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Minneapolis, Minnesota, 55407
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Minneapolis, Minnesota, 55415
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Minneapolis, Minnesota, 55417
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Miramar, Florida, 33025
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Mobile, Alabama, 36617
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Mobile, Alabama, 36693
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Murray, Utah, 84157
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Naples, Florida, 34102
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Nashville, Tennessee, 37203
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Natrona Heights, Pennsylvania, 15065
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New Orleans, Louisiana, 70112
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New Orleans, Louisiana, 70121
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New York, New York, 10021
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New York, New York, 10025
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New York, New York, 10029
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New York, New York, 10032
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Newark, New Jersey, 07103
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Northridge, California, 91325
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Ocala, Florida, 34471
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Odessa, Texas, 79761
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Oklahoma City, Oklahoma, 73103
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Omaha, Nebraska, 68114
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Omaha, Nebraska, 68131
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Opelousas, Louisiana, 70570
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Orange, California, 92868
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Orlando, Florida, 32806
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Owensboro, Kentucky, 42303
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Oxon Hill, Maryland, 20745
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Panama City, Florida, 32401
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Pawtucket, Rhode Island, 02860
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Petoskey, Michigan, 49770
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Philadelphia, Pennsylvania, 19106
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Philadelphia, Pennsylvania, 19107
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Philadelphia, Pennsylvania, 19140
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Phoenix, Arizona, 85023
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Phoenix, Arizona, 85029
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Picayune, Mississippi, 39466
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Plano, Texas, 75024
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Pomona, California, 91767
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Portland, Oregon, 97239
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Pottstown, Pennsylvania, 19464
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Providence, Rhode Island, 02903
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Providence, Rhode Island, 02906
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Redondo Beach, California, 90277
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Roanoke, Virginia, 24104
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Rochester, Minnesota, 55905
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Rocky Mount, North Carolina, 27804
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Royal Oak, Michigan, 48073
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Saginaw, Michigan, 48602
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Saginaw, Michigan, 48604
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Saint Cloud, Minnesota, 56362
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Saint Paul, Minnesota, 55102
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Salinas, California, 93901
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Salisbury, Maryland, 21801
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San Antonio, Texas, 78205
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San Antonio, Texas, 78229
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San Antonio, Texas, 78258
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San Diego, California, 92103
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San Francisco, California, 94115
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Santa Ana, California, 92704
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Sarasota, Florida, 34239
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Sarasota, Florida, 34292
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Seaford, Delaware, 19973
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Shreveport, Louisiana, 71101
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Shreveport, Louisiana, 71105
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Slidell, Louisiana, 70458
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Somerset, New Jersey, 08873
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Springfield, Ohio, 45505
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St. Petersburg, Florida, 33701
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St. Petersburg, Florida, 33709
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Stamford, Connecticut, 06905
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Suffern, New York, 10901
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Sylmar, California, 91342
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Syracuse, New York, 13210
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Tampa, Florida, 33613
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The Bronx, New York, 10469
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Thousand Oaks, California, 91360
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Toledo, Ohio, 43608
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Tomball, Texas, 77375
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Torrance, California, 90502
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Trinity, Florida, 34652
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Troy, New York, 12180
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Tucson, Arizona, 85712
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Tucson, Arizona, 85724-5078
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Tullahoma, Tennessee, 37388
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Tulsa, Oklahoma, 74104
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Upper Darby, Pennsylvania, 19082
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Ventura, California, 90265
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Vero Beach, Florida, 32960
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Victoria, Texas, 77901
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Washington, Missouri, 63090
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Winston-Salem, North Carolina, 27103
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Worcester, Massachusetts, 01604
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Zachary, Louisiana, 70791
Canada62 sites
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Bathurst, New Brunswick, E2A 1A9
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Brampton, Ontario, L6W2X7
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Brampton, Ontario, L6Z 4N5
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Bridgewater, Nova Scotia, B4V 3N2
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Burlington, Ontario, L7M 4Y1
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Burlington, Ontario, L7R4EZ
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Cambridge, Ontario, N1R 6V6
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Cambridge, Ontario, N1R 7R1
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Charlottetown, Prince Edward Island, C1A 8T5
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Chicoutimi, Quebec, G7H 5H6
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Chicoutimi, Quebec, G7H 7Y8
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Edmonton, Alberta, T5H 3V9
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Edmonton, Alberta, T6G1Z1
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Edmonton, Alberta, T6K 4C1
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Fort Eire, Ontario, L2A1Z3
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Gatineau, Quebec, J8Y 6S9
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Granby, Quebec, J2G 1T7
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Granby, Quebec, J2G 8Z9
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Greater Sudbury, Ontario, P3C 5K7
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Greater Sudbury, Ontario, P3E 3B8
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Greater Sudbury, Ontario, P3E 5J1
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Halifax, Nova Scotia, B3H 2Y9
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Hamilton, Ontario, L8L 2X2
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Kingston, Ontario, K7L 5G2
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Kitchener, Ontario, N2M 1B2
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Laval, Quebec, H7M 3L9
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Lévis, Quebec, G6V 4Z5
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London, Ontario, N6A 4L6
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London, Ontario, N6C 5J1
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Longueuil, Quebec, J4M 2X1
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Mississauga, Ontario, L4T2J2
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Mississauga, Ontario, L5B 2P7
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Moncton, New Brunswick, E1G 1A7
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Moncton, New Brunswick, E1L 2Z3
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Montreal, Quebec, H1T 1C8
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Montreal, Quebec, H2K 4L5
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Montreal, Quebec, H3G 1A4
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Montreal, Quebec, H4J 1C5
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New Westminster, British Columbia, V3L 3W4
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Newmarket, Ontario, L3Y 8C3
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Oshawa, Ontario, L1H 1B9
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Québec, Quebec, G1G 3Z4
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Québec, Quebec, G1N 4V3
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Red Deer, Alberta, T4N 6R2
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Saint John, New Brunswick, E2L 4L2
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Saint-Charles-Borromée, Quebec, J6E 6J2
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Saint-Jérôme, Quebec, J7Z 5T3
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Saint-Lambert, Quebec, J4P 2H4
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Saint-Laurent, Quebec, H4T 1Z9
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Saint-Léonard, Quebec, H1S 3A9
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Sherbrooke, Quebec, J1H 5N4
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Sherbrooke, Quebec, J1J 2E3
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Smiths Falls, Ontario, K7A 4W8
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St. John's, Newfoundland and Labrador, A1E2C2
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Ste. Foy, Quebec, G1V 4G5
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Surrey, British Columbia, V3V 1Z2
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Terrebonne, Quebec, J6V 2H2
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Thunder Bay, Ontario, P7B 6V4
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Toronto, Ontario, M5B 1W8
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Trois-Rivières, Quebec, G8Z 3R9
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Val DOr, Quebec, J9P 3Y1
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Vaudreuil-Dorion, Quebec, J7V 8P9
Poland52 sites
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£ódx, 91-347
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Bêdzin, 42-500
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Bialystok, 15-276
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Bielsko-Biala, 43-316
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Bydgoszcz, 85-826
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Bydgoszcz, 85-863
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Bytom, 41-902
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Cracow, 30-092
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Gdansk, 80-126
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Gdansk, 80-952
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Gdynia, 81-402
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Gdynia, 81-423
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Gdynia, 81-472
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Gdynia, 81-519
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Gorlice, 38-300
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Grodzisk Mazowiecki, 05-754
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Katowice, 40-005
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Kędzierzyn-Koźle, 47-200
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Kielce, 25-315
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Krakow, 30-082
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Krakow, 31-202
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Krakow, 31-351
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Kutno, 99-300
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Libiąż, 32-590
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Lodz, 91-302
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Lodz, 91-490
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Lublin, 20-059
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Lublin, 20-834
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Nowa Sól, 67-100
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Nysa, 48-303
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Oława, 55-200
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Olesnica, Spalice, 56-400
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Olsztyn, 10-561
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Poznan, 61-848
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Puławy, 24-100
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Radom, 26-600
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Rzeszów, 35301
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Swidnica, 58-100
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Tarnów, 33-100
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Torun, 87-100
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Ustroń, 43-450
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Ustroñ, 43-450
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Warsaw, 02-097
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Warsaw, 02-637
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Warsaw, 03-242
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Warsaw, 03-599
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Warsaw, 04-141
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Wola, 43-225
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Wroclaw, 50-981
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Zamość, 22-400
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Żarów, 58-130
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Zgorzelec, 59-900
China40 sites
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Baotou, 014040
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Beijing, 100020
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Beijing, 100029
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Beijing, 100038
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Beijing, 100050
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Beijing, 100088
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Beijing, 100101
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Beijing, 10029
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Beijing, 100730
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Beijing, 100853
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Beijng, 100700
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Changsha, 410007
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Changsha, 410011
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Changsha, 410013
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Chengdu, 610041
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Dalian, 116011
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Daqing, 163001
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Guangzhou, 510030
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Guangzhou, 510080
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Hangzhou, 310003
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Hangzhou, 310013
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Hangzhou, 310016
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Jinan, 250012
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Nanjing, 210009
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Nanning, 530021
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Qingdao, 266011
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Shanghai, 200001
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Shanghai, 200011
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Shanghai, 200030
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Shanghai, 200031
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Shanghai, 200040
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Shanghai, 200065
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Shanghai, 200072
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Shanghai, 200233
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Shenyang, 110004
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Shenyang, 110016
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Shijiazhuang, 050082
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Tianjin, 300014
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Wuhan, 430071
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Xi'an, 710061
Germany40 sites
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Bad Krozingen, 79189
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Bad Nauheim, 61231
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Bad Oeynhausen, 32545
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Bad Rothenfelde, 49124
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Berlin, 12203
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Berlin, 12559
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Berlin, 13187
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Berlin, 13353
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Berlin, 14050
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Bernried, 82347
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Bochum, 44789
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Bonn, 53127
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Brandenburg, 14770
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Burg, 03096
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Cologne, 50923
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Dortmund, 44137
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Düsseldorf, 40225
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Essen, 45122
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Frankfurt, 65929
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Fulda, 36043
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Fürth, 90766
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Halle, 06120
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Hamburg, 20099
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Hanover, 30167
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Heidelberg, 69126
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Homburg/Saar, 66424
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Kiel, 24105
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Lahr, 77933
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Langen, 63225
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Mainz, 55131
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Mannheim, 68167
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Mönchengladbach, 41063
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München, 80336
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Münster, 48149
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Nienburg, 31582
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Pirna, 01796
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Regensburg, 93053
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Rotenburg (Wümme), 36199
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Rüdersdorf, 15562
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Wuppertal, 42117
India40 sites
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Ahmedabad, 380005
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Ahmedabad, 380014
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Ahmedabad, 380015
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Ahmedabad, 380051
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Bangalore, 560038
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Bangalore, 560060
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Bangalore, 560099
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Banglore, 560034
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Belagavi, 590001
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Belagavi, 590010
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Chennai, 600100
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Gūrgaon, 122001
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Hyderabad, 500001
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Hyderabad, 500004
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Hyderabad, 500024
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Hyderabad, 500034
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Hyderabad, 500063
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Indore, 452001
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Jaipur, 302004
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Kochi, Kerala, 682304
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Kochi, 682041
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Kolkata, 700020
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Lucknow, 226014
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Madurai, 625107
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Mangalore, 575 002
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Mangalore, 575001
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Mangalore, 575002
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Mumbai, 400012
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Mumbai, 400051
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Mysore, 570004
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Nagpur, 440008
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Nagpur, 440010
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New Delhi, 110060
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Palakkad, 678013
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Pune, Maharashtra, 411011
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Pune, 411 001
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Pune, 411004
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Pune, 411030
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Secunderabad, 500003
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Trivandeum, 695011
Brazil37 sites
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Belo Horizonte, Minas Gerais, 30110-068
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Belo Horizonte, Minas Gerais, 30150-221
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Belo Horizonte, Minas Gerais, 30150-240
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Brasília, Federal District, 71625-009
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Campina Grande do Sul, Paraná, 83430-000
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Campinas, São Paulo, 13024-011
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Campinas, São Paulo, 13060-803
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Campo Grande, Mato Grosso do Sul, 79070900
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Cariacica, Espírito Santo, 29151920
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Curitiba, Paraná, 80220-000
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Curitiba, Paraná, 80320-320
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Curitiba, Paraná, 80730-150
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Fortaleza, Ceará, 60115282
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Fortaleza, Ceará, 60430-370
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Fortaleza, Ceará, 60430970
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Fortaleza, Ceará, 60840285
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Goiânia, Goiás, 74823-470
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Natal, Rio Grande do Norte, 59020-100
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Passo Fundo, Rio Grande do Sul, 99010-080
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Porto Alegre, Rio Grande do Sul, 90020-090
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Porto Alegre, Rio Grande do Sul, 90035-003
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Porto Alegre, Rio Grande do Sul, 90035-170
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Porto Alegre, Rio Grande do Sul, 90110-270
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Porto Alegre, Rio Grande do Sul, 90610-000
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Porto Alegre, Rio Grande do Sul, 90620-001
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Porto Alegre, Rio Grande do Sul, 91350-200
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Recife, Pernambuco, 50100-060
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Rio de Janeiro, Rio de Janeiro, 22240-006
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Rio de Janeiro, Rio de Janeiro, 22271-100
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Salvador, Estado de Bahia, 40010020
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São José, Santa Catarina, 88103-460
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Sao Jose Do Rio Preto, Santa Catarina, 15015-210
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São José do Rio Preto, São Paulo, 15090-000
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São Paulo, São Paulo, 01244-030
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São Paulo, São Paulo, 05403-000
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São Paulo, São Paulo, 1506000
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Uberlândia, Minas Gerais, 38400-368
Mexico33 sites
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Acapulco, 39670
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Aguascalientes, 20127
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Aguascalientes, 20230
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Chihuahua City, 31000
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Chihuahua City, 31217
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Ciudad Juárez, 32420
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Cuernavaca, 62250
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Culiacán, 80020
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Durango, 34000
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Durango, 34080
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Guadalajara, 44210
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Guadalajara, 44600
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Guadalajara, 44650
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Mexico City, 10700
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Mexico City, 11650
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Mexico City, 14000
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Mexico City, 14050
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Mexico City, 14080
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Monterrey, 64060
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Monterrey, 64460
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Monterrey, 64640
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Monterrey, 64710
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Pachuca, 42000
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Puebla City, 72490
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Puerto Vallarta, 48328
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Querétaro, 76000
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San Luis Potosi S.l.p., 78240
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Tampico, 89000
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Tijuana, 22010
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Tlalnepantla, 54055
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Veracruz, 91700
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Xalapa, 91020
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Zapopan, 45200
Spain33 sites
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A Coruña, La Coruña, 15006
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Alcorcón, Madrid, 28922
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Alicante, Alicante, 03010
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Almería, Almeria, 04009
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Barcelona, Barcelona, 08003
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Barcelona, Barcelona, 08025
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Barcelona, Barcelona, 08035
Study site
Bilbao, Vizcaya, 48013
Study site
Ferrol, La Coruña, 15405
Study site
Figueres, Girona, 17600
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Granollers, Barcelona, 08400
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Guadalajara, Guadalajara, 19002
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Jerez de la Frontera, Cadiz, 11402
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L'Hospitalet de Llobregat, Barcelona, 08907
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Lugo, Lugo, 27004
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Madrid, Madrid, 28007
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Madrid, Madrid, 28040
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Madrid, Madrid, 28041
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Málaga, Malaga, 29010
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Murcia, Murcia, 30008
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Oviedo, Principality of Asturias, 33006
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Reus, Tarragona, 43201
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Sabadell, Barcelona, 08208
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Salamanca, Salamanca, 37007
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San Sebastián de los Reyes, Madrid, 28702
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Santiago de Compostela, La Coruña, 15706
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Seville, Sevilla, 41071
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Tarragona, Tarragona, 43007
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Terrassa, Barcelona, 08227
Study site
Torrevieja, Alicante, 03186
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Valencia, Valencia, 46014
Study site
Valencia, Valencia, 46017
Study site
Vitoria-Gasteiz, Alava, 01009
United Kingdom29 sites
Study site
Abano Terme, 35031
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Antrim, BT41 2RL
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Ayr, KA6 6DX
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Basildon, SS16 5NL
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Bath, BA1 3NG
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Belfast, BT13 3BW
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Belfast, BT47 6SB
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Brighton, BN2 1ES
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Cambridge, CB2 0QQ
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Craigavon, BT63 5QQ
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Derby, DE22 3DT
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Glasgow, G11 6NK
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Harrow, HA1 3UJ
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Inverness, IV2 4RE
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Isle of Wight, 30 5TG.
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Isleworth, TW7 6AF
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Leeds
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London, E1 2AT
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Manchester, M13 9WL
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Middlesex, UB1 3HW
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Newcastle upon Tyne, NE7 7DN
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Northampton, NN1 5BD
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Paddington, W2 1LA
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Plymouth, PL6 8BX
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Poole, BH15 2JB
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Romford, RM7 0AG
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Stoker on Trent, ST4 6QG
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West Bromwich, B71 4HJ
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Wrexham, LL137TD
Argentina28 sites
Study site
Buenos Aires, 1425DES
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Buenos Aires, 1428
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Buenos Aires, C1155ADP
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Buenos Aires, c1181ach
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Buenos Aires, C1425AGC
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Buenos Aires, C1426AGU
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Buenos Aires, C1437BZL
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Caba, C1119ACN
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Caba, C1405BCK
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Caba, C1428DCO
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Capital Federal, 1180
Study site
Ciudad Autonoma Bs As, C1280AEB
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Córdoba, 5000
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Córdoba, 5009
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Córdoba, X5000EPU
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Coronel Suárez, B7540GDH
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Corrientes, W3400AMZ
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Haedo, B1706AJU
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Mendoza, 5500
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Morón, 1708
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Rosario, 2000
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Rosario, S2000DIF
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Rosario, S2002OUR
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Salta, 4400
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San Miguel de Tucumán, 4000
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Santa Fe, 3000
Study site
Santiago del Estero, G4200AQK
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Zárate, 2800
South Korea27 sites
Study site
Busan, 47392
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Busan, 49267
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Busan, 602-739
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Daegu, 41931
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Daegu, 705-717
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Daejeon, 35015
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Gwangju, 61469
Study site
Gyeonggi-do, 10380
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Gyeonggi-do, 14647
Study site
Gyeonggi-do, 431-070
Study site
Gyeonggi-do, 443-380
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Incheon, 400-711
Study site
Incheon, 405-760
Study site
Jeollabuk-do, 561-712
Study site
Kyonggi-do, 411-719
Study site
Seoul, 03080
Study site
Seoul, 06973
Study site
Seoul, 130-702
Study site
Seoul, 136-705
Study site
Seoul, 140-743
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Seoul, 150-950
Study site
Seoul, 152-703
Study site
Seoul, 156-707
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Suwon, 442-723
Study site
Uijongbu, 480-130
Study site
Ulsan, 44033
Study site
Wŏnju, 220-701
Australia22 sites
Study site
Adelaide, South Australia, 5000
Study site
Ballarat, Victoria, 3353
Study site
Bankstown, New South Wales, 2200
Study site
Concord, New South Wales, 2139
Study site
Darlinghurst, New South Wales, 2010
Study site
Douglas, Queensland, 4184
Study site
Elizabeth Vale, South Australia, 5112
Study site
Garran, Australian Capital Territory, 2605
Study site
Geelong, Victoria, 3220
Study site
Liverpool BC, New South Wales, 1871
Study site
Milton, Queensland, 4064
Study site
New Lambton, New South Wales, 2305
Study site
Penrith, New South Wales, 2751
Study site
Redcliffe, Queensland, 4020
Study site
Richmond, Victoria, 3121
Study site
Shepparton, Victoria, 3630
Study site
Southport, Queensland, 4215
Study site
St Leonards, New South Wales, 2065
Study site
Sydney, New South Wales, 2217
Study site
Wollongong, New South Wales, 2500
Study site
Woodville, South Australia, 5011
Study site
Woolloongabba, Queensland, 4102
France17 sites
Study site
Albi, 81000
Study site
Besançon, 25000
Study site
Bron, 69677
Study site
Cambrai, 59407
Study site
Créteil, 94010
Study site
Dijon, 21079
Study site
Lagny-sur-Marne, 77405
Study site
Le Coudray, 28630
Study site
Le Plessis-Robinson, 92350
Study site
Marseille, 13285
Study site
Montfermeil, 93370
Study site
Montpellier, 34295
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Paris, 75651
Study site
Paris, 75908
Study site
Pessac, 3600
Study site
Saint-Herblain, 44800
Study site
Valenciennes, 59322
Hungary17 sites
Study site
Balatonfüred, 8230
Study site
Budapest, 1032
Study site
Budapest, 1085
Study site
Budapest, 1088
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Budapest, 1096
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Budapest, 1097
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Budapest, 1115
Study site
Debrecen, 4032
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Gyula, 5700
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Kaposvár, 7400
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Kecskemét, 6000
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Miskolc, 3526
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Pécs, 7643
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Székeshehérvár, 8000
Study site
Szolnok, 5004
Study site
Szombathely, 9700
Study site
Zalaegerszeg, 8900
Italy16 sites
Study site
Bentivoglio, Emilia-Romagna, 40010
Study site
Bergamo, Lombardy, 24128
Study site
Cittadella, Veneto, 35013
Study site
Ferrara, Emilia-Romagna, 44100
Study site
Legnano, Lombardy, 20025
Study site
Mantua, Lombardy, 46100
Study site
Milan, Lombardy, 20138
Study site
Milan, Lombardy, 20162
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Naples, Campania, 80131
Study site
Pavia, Lombardy, 27100
Study site
Perugia, Umbria, 06100
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Pozzuoli, Campania, 80078
Study site
Reggio Emilia, Emilia-Romagna, 42123
Study site
Rome, Lazio, 00189
Study site
Rovigo, Veneto, 45100
Study site
Udine, Friuli Venezia Giulia, 33100
Netherlands14 sites
Study site
AC Amsterdam, 1091
Study site
Amstelveen, 1186 AH
Study site
Amsterdam, 1066 EC
Study site
Amsterdam, 1105 AZ
Study site
Hoorn, 1625 HV
Study site
Leiden, 2333 ZA
Study site
Maastricht, 6202 AZ
Study site
Nieuwegein, 3435 CM
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Nijmegen, 6500 HB
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Purmerend, 1441 RN
Study site
Tilburg, 5042 AD
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Weert, 6001 BE
Study site
Zaandam, 1502 DV
Study site
Zwolle, 8011 JW
Thailand14 sites
Study site
Amphur Mae-Rim, 50180
Study site
Amphur Muang, 57000
Study site
Amphur Muang, 65000
Study site
Bangkok, 10300
Study site
Bangkok, 10330
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Bangkok, 10400
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Bangkok, 10700
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Changwat Sara Buri, 18000
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Chiang Mai, 50200
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Chon Buri, 20000
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Khon Kaen, 40002
Study site
Khonkaen, 40000
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Klong Luang, 12120
Study site
Phitsanulok, 65000
Czechia13 sites
Study site
Brno, 625 00
Study site
Brno, CA-656 91
Study site
Hradec Králové, 50005
Study site
Jindřichův Hradec, 37701
Study site
Kladno, 27259
Study site
Olomouc, 77520
Study site
Prague, 128 00
Study site
Prague, 128 08
Study site
Prague, 14021
Study site
Tábor, 390 03
Study site
Teplice, 41529
Study site
Trutnov, 541 01
Study site
Znojmo, 669 02
Sweden12 sites
Study site
Danderyd Stockholm, SE-182 88
Study site
Gothenburg, 413 45
Study site
Halmstad, 301 85
Study site
Kalmar, 391 85
Study site
Karlstad, 65185
Study site
Kristianstad, 29185
Study site
Malmö, 20502
Study site
Östersund, 83 183
Study site
Skellefteå, 0910-77
Study site
Skövde, 541 85
Study site
Stockholm, 11883
Study site
Stockholm, 17176
Romania11 sites
Study site
Brasov, 500360
Study site
Bucharest, 010628
Study site
Bucharest, 020992
Study site
Buzău, 120203
Study site
Cluj-Napoca, 400006
Study site
Craiova, 200147
Study site
Galati, 800371
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Oradea, 410169
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Ploieşti, 100163
Study site
Târgu Mureş, 540124
Study site
Timișoara, 300310
Malaysia8 sites
Study site
George Town, 10990
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Kelantan, 16150
Study site
Kota Bharu, 15586
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Kuala Lumpur, 50400
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Kuala Lumpur, 59100
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Kuantan, 25100
Study site
Sarawak, Sarawak, 93586
Study site
Serdang, 43000
New Zealand7 sites
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Auckland
Study site
Christchurch, 8140
Study site
Hamiton, 3240
Study site
Lower Hutt, 5040
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Nelson, 7001
Study site
Palmerston North, 4410
Study site
Tauranga, 3112
Denmark6 sites
Study site
Aalborg, 9000
Study site
Copenhagen
Study site
Fredericia, 7000
Study site
Herning, 7400
Study site
Odense, 5000 C
Study site
Slagelse, 4200
Ireland6 sites
Study site
Ballinasloe
Study site
Dublin, 7
Study site
Dublin, 8
Study site
Dublin, 9
Study site
Galway
Study site
Tallaght Dublin, D24
Russia4 sites
Study site
Moscow, 111539
Study site
Saint Petersburg, 193312
Study site
Saint Petersburg, 194291
Study site
Saint Petersburg, 197341
Grenada1 site
Study site
Toulouse, 31059
About this study
Official title: A Safety and Efficacy Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Coronary Heart Disease (CHD) Patients With a Recent Acute Coronary Syndrome (ACS) Event and Type 2 Diabetes Mellitus (T2D)
This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Aleglitazar, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AleglitazarDrug
aleglitazar 150 micrograms po daily
PlaceboDrug
placebo control po daily
| Study group | Role | What they receive |
|---|---|---|
| Aleglitazar | Experimental | Not described Receives: Drug: Aleglitazar |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke
Measured: Throughout study, approximately 4.5 years
Secondary outcomes (3)
Effects on other cardiovascular endpoints
Measured: Throughout study, approximately 4.5 years
Glycemic control, lipoprotein profile, blood pressure, biomarkers of cardiovascular risk
Measured: Throughout study, months 1, 3, 6, 9, 12 and then every 6 months thereafter
Tolerability and long-term safety profile
Measured: Throughout study, approximately 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7,226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042769
- Sponsor's protocol ID
- BC22140
- Other IDs
- 2009-012269-71, 2009
- Status last verified
- Nov 2016
- First submitted
- 5 Jan 2010
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Schrieks IC, Nozza A, Stahli BE, Buse JB, Henry RR, Malmberg K, Neal B, Nicholls SJ, Ryden L, Mellbin L, Svensson A, Wedel H, Weichert A, Lincoff AM, Tardif JC, Grobbee DE, Schwartz GG. Adiponectin, Free Fatty Acids, and Cardiovascular Outcomes in Patients With Type 2 Diabetes and Acute Coronary Syndrome. Diabetes Care. 2018 Aug;41(8):1792-1800. doi: 10.2337/dc18-0158. Epub 2018 Jun 14.
PubMed 29903845Lincoff AM, Tardif JC, Schwartz GG, Nicholls SJ, Ryden L, Neal B, Malmberg K, Wedel H, Buse JB, Henry RR, Weichert A, Cannata R, Svensson A, Volz D, Grobbee DE; AleCardio Investigators. Effect of aleglitazar on cardiovascular outcomes after acute coronary syndrome in patients with type 2 diabetes mellitus: the AleCardio randomized clinical trial. JAMA. 2014 Apr 16;311(15):1515-25. doi: 10.1001/jama.2014.3321.
PubMed 24682069Lincoff AM, Tardif JC, Neal B, Nicholls SJ, Ryden L, Schwartz GG, Malmberg K, Buse JB, Henry RR, Wedel H, Weichert A, Cannata R, Grobbee DE. Evaluation of the dual peroxisome proliferator-activated receptor alpha/gamma agonist aleglitazar to reduce cardiovascular events in patients with acute coronary syndrome and type 2 diabetes mellitus: rationale and design of the AleCardio trial. Am Heart J. 2013 Sep;166(3):429-34. doi: 10.1016/j.ahj.2013.05.013. Epub 2013 Jul 26.
PubMed 24016490
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Coronary Heart Disease (CHD) Patients With a Recent Acute Coronary Syndrome (ACS) Event and Type 2 Diabetes Mellitus (T2D)
- ClinicalTrials.gov ID
- NCT01042769
- Acronym / sponsor ID
- BC22140
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,226 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 6 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aleglitazar | Experimental | Drug: Aleglitazar |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults >18 years of age
- Type 2 diabetes mellitus
- Hospitalization for ACS event and randomization between hospital discharge and 8 weeks after the ACS index event (day of hospitalization)
Key exclusion criteria (5 listed)
- Estimated glomerular filtration rate <45 mL/min/1.73m2
- Concomitant treatment with a thiazolidinedione and/or fibrate
- Triglycerides >400 mg/dL
- Anaemia
- Symptomatic congestive heart failure classified as New York Heart Association (NYHA) class II-IV (France and Germany: Symptomatic congestive heart failure classified as NYHA class I-IV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aleglitazaraleglitazar 150 micrograms po daily | Drug | Aleglitazar |
| Placeboplacebo control po daily | Drug | Placebo |
Primary outcome
Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke
Time frame: Throughout study, approximately 4.5 years
3 secondary outcomes
Effects on other cardiovascular endpoints
Time frame: Throughout study, approximately 4.5 years
Glycemic control, lipoprotein profile, blood pressure, biomarkers of cardiovascular risk
Time frame: Throughout study, months 1, 3, 6, 9, 12 and then every 6 months thereafter
Tolerability and long-term safety profile
Time frame: Throughout study, approximately 4.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Derived from this study: PubMed 29903845Schrieks IC, Nozza A, Stahli BE, Buse JB, Henry RR, Malmberg K, Neal B, Nicholls SJ, Ryden L, Mellbin L, Svensson A, Wedel H, Weichert A, Lincoff AM, Tardif JC, Grobbee DE, Schwartz GG. Adiponectin, Free Fatty Acids, and Cardiovascular Outcomes in Patients With Type 2 Diabetes and Acute Coronary Syndrome. Diabetes Care. 2018 Aug;41(8):1792-1800. doi: 10.2337/dc18-0158. Epub 2018 Jun 14.
- Derived from this study: PubMed 24682069Lincoff AM, Tardif JC, Schwartz GG, Nicholls SJ, Ryden L, Neal B, Malmberg K, Wedel H, Buse JB, Henry RR, Weichert A, Cannata R, Svensson A, Volz D, Grobbee DE; AleCardio Investigators. Effect of aleglitazar on cardiovascular outcomes after acute coronary syndrome in patients with type 2 diabetes mellitus: the AleCardio randomized clinical trial. JAMA. 2014 Apr 16;311(15):1515-25. doi: 10.1001/jama.2014.3321.
- Derived from this study: PubMed 24016490Lincoff AM, Tardif JC, Neal B, Nicholls SJ, Ryden L, Schwartz GG, Malmberg K, Buse JB, Henry RR, Wedel H, Weichert A, Cannata R, Grobbee DE. Evaluation of the dual peroxisome proliferator-activated receptor alpha/gamma agonist aleglitazar to reduce cardiovascular events in patients with acute coronary syndrome and type 2 diabetes mellitus: rationale and design of the AleCardio trial. Am Heart J. 2013 Sep;166(3):429-34. doi: 10.1016/j.ahj.2013.05.013. Epub 2013 Jul 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
810 sites in 27 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aleglitazar in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 810 sites in 27 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 810 sites in United States, Canada, Poland, China, Germany and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke (time frame: Throughout study, approximately 4.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01042769, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.