Diabetes Mellitus, Type 2Phase 4IOOVNCT00279201
The DURABLE Trial: Evaluating the Durability of Starter Insulin Regimens in Patients With Type 2 Diabetes (IOOV)
A Phase 4 study testing Insulin glargine, Lispro Low Mix and Lispro Mid Mix in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 199 sites in 12 countries.
Trial summary
This study will compare insulin lispro low mixture [LM] and insulin glargine both in combination with the patient's oral diabetes medicines, for their ability to control blood sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine with regard to the length of time that the overall… Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin glargine, Lispro Low Mix and Lispro Mid Mix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,091 participants
- Where
- 199 sitesin 12 countries
- Study dates
- Dec 2005to Nov 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have type 2 diabetes.
- Must be at least 30 and less than 80 years of age at the time of Visit 1.
- Must be on at least two oral antidiabetes medications for at least 90 days.
- Must have an HbA1c 1.2 to 2.0 times the upper limit of normal reference range at the local lab.
Who cannot join
- Must not have used insulin on a regular basis in the last 12 months.
- Must not have had more than one episode of severe hypoglycemia in the last 24 weeks.
- Must not have a body mass index (BMI) of greater than 45 (morbid obesity).
- Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease.
- Must not be pregnant or intend to get pregnant during course of the study.
Trial locations and contacts
199 sites in 12 countries.
199 sites in 12 countries
United States138 sites
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Abilene, Texas, 79601
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Akron, Ohio, 44313
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Anaheim, California, 92805
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Athens, Georgia, 30606
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Atlanta, Georgia, 30342
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Baltimore, Maryland, 21204
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Bangor, Maine, 04401
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Baton Rouge, Louisiana, 70808
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Beaver, Pennsylvania, 15009
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Belleville, Illinois, 62220
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Bellingham, Washington, 98226
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Bend, Oregon, 97708
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Beverly Hills, California, 90211
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Bloomfield Hills, Michigan, 48302
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Bloomington, Minnesota, 55420
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Bowling Green, Kentucky, 42101
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Burlingame, California, 94010
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Charleston, South Carolina, 29412
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Charlotte, North Carolina, 28226
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Cherry Hill, New Jersey, 08034
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Chesterfield, Missouri, 63017
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Chicago, Illinois, 60612
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Cincinnati, Ohio, 45224
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Cleveland, Ohio, 44122
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Colorado Springs, Colorado, 80917
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Columbus, Ohio, 43201
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Concord, California, 94520
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Cooperstown, New York, 13326
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Cromwell, Connecticut, 06416
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Dallas, Texas, 75246
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Dayton, Ohio, 45439
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Deerfield Beach, Florida, 33441
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Eau Claire, Wisconsin, 54701
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El Paso, Texas, 79935
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Elkridge, Maryland, 21075
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Elkton, Maryland, 21921
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Eugene, Oregon, 97401
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Everett, Washington, 98208
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Fargo, North Dakota, 58104
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Fleetwood, Pennsylvania, 19522
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Flemington, New Jersey, 08822
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Fort Wayne, Indiana, 46804
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Fountain Valley, California, 92708
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Franklin, Ohio, 45005
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Fresno, California, 93720
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Gainesville, Florida, 32605
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Greenbrae, California, 94904
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Greenville, North Carolina, 27834
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Greenville, South Carolina, 29605
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Gurnee, Illinois, 60031
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Hamilton, New Jersey, 08610
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Hartsville, South Carolina, 29550
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Haverhill, Massachusetts, 01830
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Honolulu, Hawaii, 96814
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Houston, Texas, 77005
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Huntersville, North Carolina, 28078
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Indianapolis, Indiana, 46256
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Inverness, Florida, 34452
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Jacksonville, Florida, 32208
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Jamestown, North Dakota, 58401
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Johnson City, Tennessee, 37604
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Kellogg, Idaho, 83837
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Killeen, Texas, 76543
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Kingsport, Tennessee, 37660
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Kissimmee, Florida, 34741
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La Jolla, California, 92093
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La Mesa, California, 91942
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Lake Worth, Florida, 33461
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Las Vegas, Nevada, 89148
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Levittown, Pennsylvania, 19056
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Litchfield Park, Arizona, 85340
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Little Rock, Arkansas, 72205
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London, Ohio, 43140
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Los Alamitos, California, 90720
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Los Angeles, California, 90095
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Los Gatos, California, 95032
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Madisonville, Kentucky, 42431
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Mamaroneck, New York, 10543
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Marshfield, Wisconsin, 54449
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Massapequa, New York, 11758
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Medford, Oregon, 97504
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Melbourne, Florida, 32901
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Memphis, Tennessee, 38119
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Metairie, Louisiana, 70006
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Miami, Florida, 33125
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Midland, Texas, 79705
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Mobile, Alabama, 36617
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Morehead City, North Carolina, 28557
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Morganton, North Carolina, 28655
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Nashua, New Hampshire, 03063
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New Braunfels, Texas, 78130
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New Hartford, New York, 13413
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New Port Richey, Florida, 34655
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New York, New York, 10032
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Norwalk, California, 90650
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O'Fallon, Illinois, 62269
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Ocala, Florida, 34471
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Ogden, Utah, 84403
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Oklahoma City, Oklahoma, 73103
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Olympia, Washington, 98502
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Orange, California, 92868
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Owensboro, Kentucky, 42303
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Palm Springs, California, 92262
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Peoria, Illinois, 61615
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Philadelphia, Pennsylvania, 19146
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Portland, Oregon, 97210
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Provo, Utah, 84604
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Reisterstown, Maryland, 21136
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Reno, Nevada, 89509
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Renton, Washington, 98057
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Rockville, Maryland, 20852
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Sacramento, California, 95825
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Salinas, California, 93901
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San Antonio, Texas, 78229
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San Diego, California, 92161
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South Burlington, Vermont, 05403
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Spring Valley, California, 91978
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St Louis, Missouri, 63104
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Stratford, New Jersey, 08084
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Syracuse, New York, 13210
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Tabor City, North Carolina, 28463
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Tampa, Florida, 33603
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Teaneck, New Jersey, 07666
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Toms River, New Jersey, 08753
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Topeka, Kansas, 66606
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Towson, Maryland, 21204
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Troy, Michigan, 48098
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Trumbull, Connecticut, 06611
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Vacaville, California, 95687
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Ventura, California, 93003
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Waltham, Massachusetts, 02453
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Waterbury, Connecticut, 06708
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Waterloo, Iowa, 50702
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Wenatchee, Washington, 98801
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West Palm Beach, Florida, 33401
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Westfield, New York, 14787
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Winter Park, Florida, 32789
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Worcester, Massachusetts, 01605
Canada9 sites
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Ajax, Ontario, L1S 7K8
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Calgary, Alberta, T3B 0M3
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Laval, Quebec, H7T 2P5
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Mississauga, Ontario, L5M 2V8
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Niagara Falls, Ontario, L2G 5X7
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Petitcodiac, New Brunswick, E4Z 4R6
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Red Deer, Alberta, T4N 6V7
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Sherbrooke, Quebec, J1G 5K2
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Winnipeg, Manitoba, R3C 0N2
India7 sites
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Ahemdabad, 380013
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Aligarh, 202002
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Bangalore, 560 054
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Coimbatore
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Hyderabaad, 500033
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Karnal/Haryana, 132 001
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Trivandrum, 695029
Netherlands7 sites
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Amsterdam, 1105 AZ
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Brunssum, 6442 BE
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Emmen, 7824 AA
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Hoogeveen, 7909 AA
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Nijmegen, 6500 HB
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Venlo, 5912 BL
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Zwijndrecht, 3331 LZ
Spain7 sites
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Alzira, 46600
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Dos Hermanas, 41014
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Madrid, 28040
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Málaga, 29010
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Mosteles, 28935
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Requena, 46340
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Santander, 39008
Australia6 sites
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Box Hill, Victoria, 3128
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Burnie, Tasmania, 7320
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Elizabeth Vale, South Australia, 5112
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Keswick, South Australia, 5035
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Kingswood Penrith, New South Wales, 2747
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Nedlands, Western Australia, 6009
Puerto Rico6 sites
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Bayamón, 00959
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Carolina, 00983
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Orcorvis, 00720
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Ponce, 00717-2075
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Rio Piedras, 00936
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San Juan, 00926
Romania5 sites
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Brasov, 500326
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Bucharest, 70266
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Cluj-Napoca, 3400
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Târgu Mureş, 540136
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Timișoara, 1900
Brazil4 sites
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Curitiba, 80060-900
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Porto Alegre, 90035170
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São Paulo, 01221-020
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Setor Oeste/Goiania, 74043-110
Hungary4 sites
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Eger, 3300
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Pécs, 7623
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Szekszárd, 7100
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Szentes, 6600
Argentina3 sites
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Buenos Aires, C1188AAF
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Mar del Plata, 7600
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Pilar, B1629ODT
Greece3 sites
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Athens, 11526
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Nikaias - Piraeus, 18454
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Thessaloniki, 56429
About this study
Official title: The Durability of Twice-Daily Insulin Lispro Low Mixture Compared to Once-Daily Insulin Glargine When Added to Existing Oral Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control
This study will compare insulin lispro low mixture [LM] and insulin glargine both in combination with the patient's oral diabetes medicines, for their ability to control blood sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine with regard to the length of time that the overall blood sugar can be controlled.
This study will also determine whether the safety of insulin lispro LM and any side effects that might be associated with it are different from those observed with insulin glargine, both in combination with the patient's oral diabetes medications.
The addendum study (Intensification Addendum) will compare how different insulin treatments work to control blood sugar in patients whose diabetes could not be controlled by either insulin lispro LM or insulin glargine.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin glargine, Lispro Low Mix, Lispro Mid Mix, Lispro
- Keywords
- diabetes, type 2
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin glargineDrug
Also called Lantus
Subcutaneous injection daily
Lispro Low MixDrug
Also called Humalog Mix 75/25
Subcutaneous injection twice daily.
Lispro Mid MixDrug
Also called Humalog Mix 50/50
Lispro Mid Mix subcutaneous injection 3 times daily.
LisproDrug
Also called Humalog
Lispro subcutaneous injection 3 times daily.
| Study group | Role | What they receive |
|---|---|---|
| Insulin glargine | Active comparator | Initiation Phase: Insulin glargine for 24 weeks Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks. Receives: Drug: Insulin glargine |
| Lispro Low Mix | Experimental | Initiation Phase: Lispro Low Mix (LM) for 24 weeks Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks. Receives: Drug: Lispro Low Mix |
| Lispro Mid Mix prior Lispro Low Mix addendum | Experimental | Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase. Receives: Drug: Lispro Mid Mix |
| Lispro Low Mix prior Glargine addendum | Experimental | Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase Receives: Drug: Lispro Low Mix |
| Basal bolus prior Lispro Low Mix addendum | Active comparator | Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase. Receives: Drug: Insulin glargine; Drug: Lispro |
| Basal bolus prior Glargine addendum | Active comparator | Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase. Receives: Drug: Insulin glargine; Drug: Lispro |
What is being measured
The primary outcome is the main question the study is designed to answer.
INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c)
Measured: Endpoint (Initiation: Week 24)
MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix)
HbA1c goal: HbA1c ≤7.0% or HbA1c >7.0% but increased <0.4% from last HbA1c ≤7.0%
Measured: Endpoint (Last Observation Carried Forward [LOCF]) (Maintenance: up to 2.5 years)
ADDENDUM: 24-Week Endpoint HbA1c
HbA1c at 24-week endpoint in Intensification Addendum of the trial.
Measured: Endpoint (Addendum) (24 weeks: Week 48)
Secondary outcomes (53)
INITIATION: Change in HbA1c From Baseline to 24 Weeks
Measured: Baseline (Initiation) to Endpoint (LOCF, Week 24)
INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint
Measured: Endpoint (Initiation: Week 24)
INITIATION: HbA1c
Measured: Baseline (Initiation), Week 12, Week 24, Endpoint (LOCF)
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.
Measured: Endpoint (LOCF) (Initiation: Week 24)
INITIATION: Change From Baseline to Endpoint in 1,5 Anhydroglucitol (1,5 AG)
Measured: Baseline (Initiation), Endpoint (Week 24)
INITIATION: Incremental Change From Baseline in Body Weight
Measured: Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)
INITIATION: Body Weight
Measured: Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)
INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes
Hypoglycemia = any time participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Measured: Baseline (Initiation), Endpoint (Week 24), Overall (sum of frequencies of hypoglycemic episodes after baseline ([Week 0]).
INITIATION: Rate of Self-reported Hypoglycemic Episodes
Hypoglycemia = participant feels/person observes, that participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Measured: Endpoint (Initiation: Week 24), Overall (incidence of hypoglycemic episodes after baseline [Week 0])
INITIATION: Insulin Dose
Measured: Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, Endpoint (LOCF)
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Age
Comparison of age at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Measured: Endpoint (Initiation: Week 24)
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin
Comparison of origin at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Measured: Endpoint (Initiation: Week 24)
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Comparison of HOMA-IR (surrogate markers of insulin resistance calculated from fasting insulin and glucose) at baseline between those participants who met their goal at Week 24 and those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%). HOMA-IR = fasting insulin (milliunits per milliliter) * fasting plasma glucose (millimoles per liter) / 22.5.
Measured: Endpoint (Initiation: Week 24)
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - HbA1c
Comparison of baseline HbA1c between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Measured: Endpoint (Initiation: Week 24)
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group
Comparison of baseline HbA1c percentage group (<8.5,>=8.5) between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Measured: Endpoint (Initiation: Week 24)
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - 1,5 AG
Comparison of 1,5 AG between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Measured: Endpoint (Initiation: Week 24)
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose
Comparison of pre meals blood glucose, post meals blood glucose, average of all blood glucose, and fasting blood glucose between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Measured: Endpoint (Initiation: Week 24)
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline
Comparison of oral diabetes medication at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Measured: Endpoint (Initiation: Week 24)
MAINTENANCE: HbA1c at Specified Visits and Endpoint
Measured: Baseline (Week 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (up to 2.5 years)
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.
Measured: Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)
MAINTENANCE: Rate of Increase in HbA1c
Rate of increase: HbA1c change/time period (month).
Measured: Endpoint (LOCF) (Maintenance: up to 2.5 years)
MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5%
Measured: Endpoint (LOCF) (Maintenance: up to 2.5 years)
MAINTENANCE: Incremental Change From Baseline in Body Weight
Measured: Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Body Weight
Measured: Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Insulin Dose
Measured: Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes
Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Measured: Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline (Week 0)
MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes
Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Measured: Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline [Week 0])
MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol
Measured: Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)
MAINTENANCE: Change From Baseline to Endpoint in HbA1c
Measured: Baseline (Week 0), Week 24, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes
Comparison of duration of diabetes at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Measured: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes
Comparison of duration of diabetes at baseline between those participants taking lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Measured: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
Comparison of duration of diabetes group (<10, 10-<20, >=20 years) at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Measured: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
Comparison of duration of diabetes group (<10, 10-<20, >=20 years) at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Measured: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c
Comparison of baseline HbA1c between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Measured: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c
Comparison of baseline HbA1c between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Measured: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group
Comparison of baseline HbA1c group (<8.5,>=8.5) between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Measured: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group
Comparison of baseline HbA1c group (<8.5,>=8.5) between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Measured: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
Comparison of oral diabetes medication at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Measured: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
Comparison of oral diabetes medication at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Measured: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG
Comparison of baseline 1,5 AG between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Measured: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG
Comparison of baseline 1,5 AG between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Measured: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose
Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Measured: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose
Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
Measured: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint
Measured: Baseline (Addendum: Week 24), Endpoint (24 weeks [Week 48])
ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5%
Measured: Endpoint (Addendum: 24 weeks [Week 48])
ADDENDUM: 7-point SMPG Profiles
Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.
Measured: Endpoint (Addendum: 24 weeks [Week 48])
ADDENDUM: Incremental Change From Baseline in Body Weight
Measured: Baseline (Addendum: Week 24), Weeks 6 (30 Weeks), 12 (36 Weeks), 24 (48 Weeks), Endpoint (LOCF)
ADDENDUM: Body Weight
Measured: Baseline (Addendum Week 24), Weeks 6 (30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)
ADDENDUM: Insulin Dose
Measured: Baseline (Addendum: Week 24), Weeks 1 (25 weeks), 2 (26 weeks), 3 (27 weeks), 4 (28 weeks), 5 (25 weeks), 6 (26 weeks), 8 (32 weeks), 10 (34 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)
ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes
Hypoglycemia = any time participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Measured: Weeks 6 (Addendum: 30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)
ADDENDUM: Rate of Self-reported Hypoglycemic Episodes
Hypoglycemia = participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Measured: Endpoint (Addendum 24 weeks), Overall (mean yearly rate of hypoglycemia during addendum phase
ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24
Measured: Baseline (addendum: 24 weeks), Endpoint (24 weeks: Week 48)
ADDENDUM: HbA1c at Specified Visits and Endpoint
Measured: Baseline (Addendum: 24 weeks), Weeks 12, 24, Endpoint (24 weeks: Week 48)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)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 Eli Lilly and CompanyThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,091 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279201
- Sponsor's protocol ID
- 10455
- Other IDs
- F3Z-US-IOOV
- Acronym
- IOOV
- Status last verified
- Jan 2011
- First submitted
- 15 Dec 2005
- Last updated
- 21 Feb 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Herman WH, Dungan KM, Wolffenbuttel BH, Buse JB, Fahrbach JL, Jiang H, Martin S. Racial and ethnic differences in mean plasma glucose, hemoglobin A1c, and 1,5-anhydroglucitol in over 2000 patients with type 2 diabetes. J Clin Endocrinol Metab. 2009 May;94(5):1689-94. doi: 10.1210/jc.2008-1940. Epub 2009 Mar 10.
PubMed 19276235Fahrbach J, Jacober S, Jiang H, Martin S. The DURABLE trial study design: comparing the safety, efficacy, and durability of insulin glargine to insulin lispro mix 75/25 added to oral antihyperglycemic agents in patients with type 2 diabetes. J Diabetes Sci Technol. 2008 Sep;2(5):831-8. doi: 10.1177/193229680800200514.
PubMed 19885269Scheen AJ, Schmitt H, Jiang HH, Ivanyi T. Individualizing treatment of type 2 diabetes by targeting postprandial or fasting hyperglycaemia: Response to a basal vs a premixed insulin regimen by HbA1c quartiles and ethnicity. Diabetes Metab. 2015 Jun;41(3):216-22. doi: 10.1016/j.diabet.2015.03.002. Epub 2015 Apr 14.
PubMed 25881510Jovanovic L, Peters AL, Jiang HH, Hardin DS. Durability of glycemic control with insulin lispro mix 75/25 versus insulin glargine for older patients with type 2 diabetes. Aging Clin Exp Res. 2014 Apr;26(2):115-21. doi: 10.1007/s40520-013-0140-8. Epub 2013 Oct 3.
PubMed 24092662Wolffenbuttel BH, Herman WH, Gross JL, Dharmalingam M, Jiang HH, Hardin DS. Ethnic differences in glycemic markers in patients with type 2 diabetes. Diabetes Care. 2013 Oct;36(10):2931-6. doi: 10.2337/dc12-2711. Epub 2013 Jun 11.
PubMed 23757434Qu Y, Jacober SJ, Zhang Q, Wolka LL, DeVries JH. Rate of hypoglycemia in insulin-treated patients with type 2 diabetes can be predicted from glycemic variability data. Diabetes Technol Ther. 2012 Nov;14(11):1008-12. doi: 10.1089/dia.2012.0099.
PubMed 23101951Buse JB, Wolffenbuttel BH, Herman WH, Hippler S, Martin SA, Jiang HH, Shenouda SK, Fahrbach JL. The DURAbility of Basal versus Lispro mix 75/25 insulin Efficacy (DURABLE) trial: comparing the durability of lispro mix 75/25 and glargine. Diabetes Care. 2011 Feb;34(2):249-55. doi: 10.2337/dc10-1701.
PubMed 21270182Miser WF, Arakaki R, Jiang H, Scism-Bacon J, Anderson PW, Fahrbach JL. Randomized, open-label, parallel-group evaluations of basal-bolus therapy versus insulin lispro premixed therapy in patients with type 2 diabetes mellitus failing to achieve control with starter insulin treatment and continuing oral antihyperglycemic drugs: a noninferiority intensification substudy of the DURABLE trial. Clin Ther. 2010 May;32(5):896-908. doi: 10.1016/j.clinthera.2010.05.001.
PubMed 20685497Wolffenbuttel BH, Klaff LJ, Bhushan R, Fahrbach JL, Jiang H, Martin S. Initiating insulin therapy in elderly patients with Type 2 diabetes: efficacy and safety of lispro mix 25 vs. basal insulin combined with oral glucose-lowering agents. Diabet Med. 2009 Nov;26(11):1147-55. doi: 10.1111/j.1464-5491.2009.02824.x.
PubMed 19929994Buse JB, Wolffenbuttel BH, Herman WH, Shemonsky NK, Jiang HH, Fahrbach JL, Scism-Bacon JL, Martin SA. DURAbility of basal versus lispro mix 75/25 insulin efficacy (DURABLE) trial 24-week results: safety and efficacy of insulin lispro mix 75/25 versus insulin glargine added to oral antihyperglycemic drugs in patients with type 2 diabetes. Diabetes Care. 2009 Jun;32(6):1007-13. doi: 10.2337/dc08-2117. Epub 2009 Mar 31.
PubMed 19336625
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Durability of Twice-Daily Insulin Lispro Low Mixture Compared to Once-Daily Insulin Glargine When Added to Existing Oral Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control
- ClinicalTrials.gov ID
- NCT00279201
- Acronym / sponsor ID
- IOOV / 10455
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes, type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,091 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 19 Jan 2006 (estimated)
- Results
- Posted 21 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare insulin lispro low mixture [LM] and insulin glargine both in combination with the patient's oral diabetes medicines, for their ability to control blood sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine with regard to the length of time that the overall blood sugar can be controlled.
This study will also determine whether the safety of insulin lispro LM and any side effects that might be associated with it are different from those observed with insulin glargine, both in combination with the patient's oral diabetes medications.
The addendum study (Intensification Addendum) will compare how different insulin treatments work to control blood sugar in patients whose diabetes could not be controlled by either insulin lispro LM or insulin glargine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Insulin glargine | Active comparator | Drug: Insulin glargineInitiation Phase: Insulin glargine for 24 weeks Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks. |
| Lispro Low Mix | Experimental | Drug: Lispro Low MixInitiation Phase: Lispro Low Mix (LM) for 24 weeks Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks. |
| Lispro Mid Mix prior Lispro Low Mix addendum | Experimental | Drug: Lispro Mid MixFollowing Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase. |
| Lispro Low Mix prior Glargine addendum | Experimental | Drug: Lispro Low MixFollowing Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase |
| Basal bolus prior Lispro Low Mix addendum | Active comparator | Drug: Insulin glargine, Drug: LisproFollowing Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase. |
| Basal bolus prior Glargine addendum | Active comparator | Drug: Insulin glargine, Drug: LisproFollowing Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase. |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must have type 2 diabetes.
- Must be at least 30 and less than 80 years of age at the time of Visit 1.
- Must be on at least two oral antidiabetes medications for at least 90 days.
- Must have an HbA1c 1.2 to 2.0 times the upper limit of normal reference range at the local lab.
Key exclusion criteria (5 listed)
- Must not have used insulin on a regular basis in the last 12 months.
- Must not have had more than one episode of severe hypoglycemia in the last 24 weeks.
- Must not have a body mass index (BMI) of greater than 45 (morbid obesity).
- Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease.
- Must not be pregnant or intend to get pregnant during course of the study.
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 |
|---|---|---|
| Insulin glargineAlso: LantusSubcutaneous injection daily | Drug | Basal bolus prior Glargine addendum, Basal bolus prior Lispro Low Mix addendum, Insulin glargine |
| Lispro Low MixAlso: Humalog Mix 75/25Subcutaneous injection twice daily. | Drug | Lispro Low Mix, Lispro Low Mix prior Glargine addendum |
| Lispro Mid MixAlso: Humalog Mix 50/50Lispro Mid Mix subcutaneous injection 3 times daily. | Drug | Lispro Mid Mix prior Lispro Low Mix addendum |
| LisproAlso: HumalogLispro subcutaneous injection 3 times daily. | Drug | Basal bolus prior Glargine addendum, Basal bolus prior Lispro Low Mix addendum |
Primary outcome
INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c)
Time frame: Endpoint (Initiation: Week 24)
MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix)
Time frame: Endpoint (Last Observation Carried Forward [LOCF]) (Maintenance: up to 2.5 years)
HbA1c goal: HbA1c ≤7.0% or HbA1c >7.0% but increased <0.4% from last HbA1c ≤7.0%
ADDENDUM: 24-Week Endpoint HbA1c
Time frame: Endpoint (Addendum) (24 weeks: Week 48)
HbA1c at 24-week endpoint in Intensification Addendum of the trial.
53 secondary outcomes
INITIATION: Change in HbA1c From Baseline to 24 Weeks
Time frame: Baseline (Initiation) to Endpoint (LOCF, Week 24)
INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint
Time frame: Endpoint (Initiation: Week 24)
INITIATION: HbA1c
Time frame: Baseline (Initiation), Week 12, Week 24, Endpoint (LOCF)
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Time frame: Endpoint (LOCF) (Initiation: Week 24)
INITIATION: Change From Baseline to Endpoint in 1,5 Anhydroglucitol (1,5 AG)
Time frame: Baseline (Initiation), Endpoint (Week 24)
INITIATION: Incremental Change From Baseline in Body Weight
Time frame: Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)
INITIATION: Body Weight
Time frame: Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)
INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes
Time frame: Baseline (Initiation), Endpoint (Week 24), Overall (sum of frequencies of hypoglycemic episodes after baseline ([Week 0]).
INITIATION: Rate of Self-reported Hypoglycemic Episodes
Time frame: Endpoint (Initiation: Week 24), Overall (incidence of hypoglycemic episodes after baseline [Week 0])
INITIATION: Insulin Dose
Time frame: Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, Endpoint (LOCF)
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Age
Time frame: Endpoint (Initiation: Week 24)
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin
Time frame: Endpoint (Initiation: Week 24)
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Endpoint (Initiation: Week 24)
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - HbA1c
Time frame: Endpoint (Initiation: Week 24)
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group
Time frame: Endpoint (Initiation: Week 24)
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - 1,5 AG
Time frame: Endpoint (Initiation: Week 24)
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose
Time frame: Endpoint (Initiation: Week 24)
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline
Time frame: Endpoint (Initiation: Week 24)
MAINTENANCE: HbA1c at Specified Visits and Endpoint
Time frame: Baseline (Week 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (up to 2.5 years)
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Time frame: Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)
MAINTENANCE: Rate of Increase in HbA1c
Time frame: Endpoint (LOCF) (Maintenance: up to 2.5 years)
MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5%
Time frame: Endpoint (LOCF) (Maintenance: up to 2.5 years)
MAINTENANCE: Incremental Change From Baseline in Body Weight
Time frame: Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Body Weight
Time frame: Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Insulin Dose
Time frame: Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline (Week 0)
MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline [Week 0])
MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol
Time frame: Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)
MAINTENANCE: Change From Baseline to Endpoint in HbA1c
Time frame: Baseline (Week 0), Week 24, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19276235Herman WH, Dungan KM, Wolffenbuttel BH, Buse JB, Fahrbach JL, Jiang H, Martin S. Racial and ethnic differences in mean plasma glucose, hemoglobin A1c, and 1,5-anhydroglucitol in over 2000 patients with type 2 diabetes. J Clin Endocrinol Metab. 2009 May;94(5):1689-94. doi: 10.1210/jc.2008-1940. Epub 2009 Mar 10.
- Results publication: PubMed 19885269Fahrbach J, Jacober S, Jiang H, Martin S. The DURABLE trial study design: comparing the safety, efficacy, and durability of insulin glargine to insulin lispro mix 75/25 added to oral antihyperglycemic agents in patients with type 2 diabetes. J Diabetes Sci Technol. 2008 Sep;2(5):831-8. doi: 10.1177/193229680800200514.
- Derived from this study: PubMed 25881510Scheen AJ, Schmitt H, Jiang HH, Ivanyi T. Individualizing treatment of type 2 diabetes by targeting postprandial or fasting hyperglycaemia: Response to a basal vs a premixed insulin regimen by HbA1c quartiles and ethnicity. Diabetes Metab. 2015 Jun;41(3):216-22. doi: 10.1016/j.diabet.2015.03.002. Epub 2015 Apr 14.
- Derived from this study: PubMed 24092662Jovanovic L, Peters AL, Jiang HH, Hardin DS. Durability of glycemic control with insulin lispro mix 75/25 versus insulin glargine for older patients with type 2 diabetes. Aging Clin Exp Res. 2014 Apr;26(2):115-21. doi: 10.1007/s40520-013-0140-8. Epub 2013 Oct 3.
- Derived from this study: PubMed 23757434Wolffenbuttel BH, Herman WH, Gross JL, Dharmalingam M, Jiang HH, Hardin DS. Ethnic differences in glycemic markers in patients with type 2 diabetes. Diabetes Care. 2013 Oct;36(10):2931-6. doi: 10.2337/dc12-2711. Epub 2013 Jun 11.
- Derived from this study: PubMed 23101951Qu Y, Jacober SJ, Zhang Q, Wolka LL, DeVries JH. Rate of hypoglycemia in insulin-treated patients with type 2 diabetes can be predicted from glycemic variability data. Diabetes Technol Ther. 2012 Nov;14(11):1008-12. doi: 10.1089/dia.2012.0099.
- Derived from this study: PubMed 21270182Buse JB, Wolffenbuttel BH, Herman WH, Hippler S, Martin SA, Jiang HH, Shenouda SK, Fahrbach JL. The DURAbility of Basal versus Lispro mix 75/25 insulin Efficacy (DURABLE) trial: comparing the durability of lispro mix 75/25 and glargine. Diabetes Care. 2011 Feb;34(2):249-55. doi: 10.2337/dc10-1701.
- Derived from this study: PubMed 20685497Miser WF, Arakaki R, Jiang H, Scism-Bacon J, Anderson PW, Fahrbach JL. Randomized, open-label, parallel-group evaluations of basal-bolus therapy versus insulin lispro premixed therapy in patients with type 2 diabetes mellitus failing to achieve control with starter insulin treatment and continuing oral antihyperglycemic drugs: a noninferiority intensification substudy of the DURABLE trial. Clin Ther. 2010 May;32(5):896-908. doi: 10.1016/j.clinthera.2010.05.001.
- Derived from this study: PubMed 19929994Wolffenbuttel BH, Klaff LJ, Bhushan R, Fahrbach JL, Jiang H, Martin S. Initiating insulin therapy in elderly patients with Type 2 diabetes: efficacy and safety of lispro mix 25 vs. basal insulin combined with oral glucose-lowering agents. Diabet Med. 2009 Nov;26(11):1147-55. doi: 10.1111/j.1464-5491.2009.02824.x.
- Derived from this study: PubMed 19336625Buse JB, Wolffenbuttel BH, Herman WH, Shemonsky NK, Jiang HH, Fahrbach JL, Scism-Bacon JL, Martin SA. DURAbility of basal versus lispro mix 75/25 insulin efficacy (DURABLE) trial 24-week results: safety and efficacy of insulin lispro mix 75/25 versus insulin glargine added to oral antihyperglycemic drugs in patients with type 2 diabetes. Diabetes Care. 2009 Jun;32(6):1007-13. doi: 10.2337/dc08-2117. Epub 2009 Mar 31.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
199 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin glargine, Lispro Low Mix and Lispro Mid Mix in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 199 sites in 12 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 4 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 21 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 199 sites in United States, Canada, India, Netherlands, Spain and 7 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c) (time frame: Endpoint (Initiation: Week 24)). The study lists 3 primary outcomes in all. 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 NCT00279201, which also lists 10 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 21 Feb 2011.