Diabetes Mellitus Type 2Phase 3NCT00717457
A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.
A Phase 3 study testing exenatide and taspoglutide in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 216 sites in 26 countries.
Trial summary
This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- exenatide and taspoglutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,189 participants
- Where
- 216 sitesin 26 countries
- Study dates
- Jul 2008to Mar 2011
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients, 18-75 years of age;
- type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks;
- HbA1c >=7.0% and <=10% at screening;
- BMI >=25kg/m2 (>23kg/m2 for Asians) and <=45kg/m2 at screening;
- stable weight +/- 5% for at least 12 weeks prior to screening.
Who cannot join
- history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes;
- history of acute metabolic diabetic complications within the previous 6 months;
- evidence of clinically significant diabetic complications;
- known proliferative diabetic retinopathy;
- myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months;
- any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator;
- known hemoglobinopathy or chronic anemia;
- clinically significant gastrointestinal disease.
Trial locations and contacts
216 sites in 26 countries.
216 sites in 26 countries
United States87 sites
Study site
Altoona, Pennsylvania, 16602
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Atlanta, Georgia, 30308
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Atlanta, Georgia, 30318
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Austin, Texas, 78705
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Baltimore, Maryland, 21209
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Bangor, Maine, 04401
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Bethesda, Maryland, 20817
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Bristol, Tennessee, 37620
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Brooklyn, New York, 11203
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Charlotte, North Carolina, 28209
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Charlotte, North Carolina, 28233
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Chicago, Illinois, 60607
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Chicago, Illinois, 60622
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Cincinnati, Ohio, 45236
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Clemson, South Carolina, 29631
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Colorado Springs, Colorado, 80904
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Columbia, South Carolina, 29201
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Columbus, Ohio, 43212
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Concord, New Hampshire, 03301
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Dallas, Texas, 75230
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Daytona Beach, Florida, 32114
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Durham, North Carolina, 27713
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Escondido, California, 92026
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Evansville, Indiana, 47714
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Everett, Washington, 98201
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Fargo, North Dakota, 58103
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Fort Lauderdale, Florida, 33316
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Green Cove Springs, Florida, 32043
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Greensboro, North Carolina, 27408
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Haleyville, Alabama, 35565
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Hickory Grove, South Carolina, 28602
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Houston, Texas, 77005
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Houston, Texas, 77024
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Houston, Texas, 77074
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Huntersville, North Carolina, 28078
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Iowa City, Iowa, 52242
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Jacksonville, Florida, 32216
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Jefferson City, Missouri, 65109
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Kansas City, Missouri, 64111
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La Jolla, California, 92037
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Little Rock, Arkansas, 72204
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Lombard, Illinois, 60148
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Medford, Oregon, 97504
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Metairie, Louisiana, 70006
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Miami Beach, Florida, 33140
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Mission Viejo, California, 92691
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Mobile, Alabama, 36617
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Montgomery, Alabama, 36106
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Munfordville, Kentucky, 42765
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New Albany, Indiana, 47150
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New York, New York, 10025
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Niceville, Florida, 32578
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Norristown, Pennsylvania, 19401
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Omaha, Nebraska, 68114
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Orange, California, 92868
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Orlando, Florida, 32804
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Palm Springs, California, 92262
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Peoria, Illinois, 61625
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Philadelphia, Pennsylvania, 19107
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Portland, Oregon, 97239
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Providence, Rhode Island, 02908
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Rancho Cucamonga, California, 91730
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Red Lion, Pennsylvania, 17356
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Richmond, Virginia, 23226
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Rochester, New York, 14607
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Rockville, Maryland, 20854
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Royal Oak, Michigan, 48073
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Sacramento, California, 95816-5119
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Salisbury, North Carolina, 28144
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San Leandro, California, 94578
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Simpsonville, South Carolina, 29681
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Smithtown, New York, 11787
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Springfield Gardens, New York, 11413
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St Louis, Missouri, 63117
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St Louis, Missouri, 63141
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Staten Island, New York, 10301
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Suwanee, Georgia, 30024
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Syracuse, New York, 13210
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Trenton, New Jersey, 08611
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Tuscaloosa, Alabama, 35406
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Voorhees Township, New Jersey, 08043
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Washington, Missouri, 63090
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West Seneca, New York, 14224
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Westfield, New York, 14787
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Westlake, Ohio, 44145
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Whitehouse, New Jersey, 08889
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Winston-Salem, North Carolina, 27103
Russia24 sites
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Barnaul, 656024
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Moscow, 109263
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Moscow, 119048
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Moscow, 119121
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Moscow, 121069
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Moscow, 125299
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Moscow, 125315
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Moscow, 129110
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Nizhny Novgorod, 603126
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Novosibirsk, 630047
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Novosibirsk, 630091
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Omsk, 644021
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S. Petersburg, 194291
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S.Petersburg, 194017
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Saint Petersburg, 191124
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Saint Petersburg, 193012
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Saint Petersburg, 194291
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Saint Petersburg, 194354
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Saint Petersburg, 195213
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Saint Petersburg, 197022
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Saratov, 140018
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Tomsk, 643050
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Yaroslavl, 150010
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Yaroslavl, 150062
Germany18 sites
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Aschaffenburg, 63739
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Berlin, 10115
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Damme, 49401
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Dresden, 01219
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Essen, 45359
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Falkensee, 14612
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Hamburg, 21073
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Hamburg, 22607
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Ludwigshafen, 67059
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Mainz, 55116
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München, 80634
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Münster, 48145
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Neuwied, 56564
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Nuremberg, 90402
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Pirna, 01796
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Rhaunen, 55624
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Villingen-Schwenningen, 78048
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Zwenkau, 04442
Mexico9 sites
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Acapulco, 39670
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Aguascalientes, 20127
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Chihuahua City, 31205
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Durango, 34000
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Guadalajara, 44600
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Guadalajara, 44650
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Monterrey, 64460
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Monterrey, 64700
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Tampico, 89000
Israel8 sites
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Beersheba, 8410101
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Haifa, 31096
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Holon, 58100
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Jerusalem, 91200
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Kfar Saba, 44281
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Petah Tikva, 49100
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Ramat Gan, 52621
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Tel Aviv, 64239
Brazil7 sites
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Belém, Pará, 66073-000
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Curtiba, Paraná, 80030-110
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Goiânia, Goiás, 74043011
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Mogi Das Cruzes - Sp, São Paulo, 08780-090
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Porto Alegre, Rio Grande do Sul, 90035-170
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São Paulo, São Paulo, 01221-020
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São Paulo, São Paulo, 04022-001
Ukraine7 sites
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Dnipro, 49044
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Donetsk, 83003
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Kiev, 02091
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Lviv, 79010
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Odesa, 65009
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Odesa, 65117
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Simferopol, 95017
France6 sites
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Corbeil-Essonnes, 91106
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Dommartin-lès-Toul, 54200
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Montpellier, 34295
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Narbonne, 11108
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Paris, 75475
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Salouël, 80480
Italy5 sites
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Genoa, Liguria, 16132
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Olbia, Sardinia, 07026
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Pavia, Lombardy, 27100
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Pordenone, Friuli Venezia Giulia, 33170
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Siena, Tuscany, 53100
United Kingdom5 sites
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Bath, BA1 2SR
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Bradford on Avon, BA15 1DQ
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Glasgow, G45 9AW
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Lanarkshire, ML1 3JX
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Trowbridge, BA14 8QA
Canada4 sites
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London, Ontario, N6A 5R8
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Pointe-Claire, Quebec, H9R 4S3
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Toronto, Ontario, M5C 2T2
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Vancouver, British Columbia, V5Z 1L8
Finland4 sites
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Helsinki, 00150
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Kuopio, 70210
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Oulu, 90100
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Turku, 20100
Spain4 sites
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Almería, Almeria, 04001
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Alzira, Valencia, 46600
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Bacarot Alicant, Alicante, 03114
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Madrid, Madrid, 28041
Sweden4 sites
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Karlstad, 65185
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Örebro, 701 85
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Stockholm, 171 76
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Uppsala, 75185
Argentina3 sites
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Buenos Aires, 6000
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Buenos Aires, C1117ABH
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Buenos Aires, C1181ACH
Peru3 sites
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Arequipa, Cercado
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Lima, 41
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Lima, Lima 33
Australia2 sites
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Camperdown, New South Wales, 2050
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Freemantle, Queensland, 6959
Guatemala2 sites
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Guatemala City, 01000
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Guatemala City, 01014
About this study
Official title: Randomized, Active Controlled, Open Label Study to Compare Taspoglutide vs Exenatide as add-on Treatment to Metformin and/or Thiazolidinediones in Patients With Type 2 Diabetes Mellitus
This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is >500 individuals.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- exenatide, taspoglutide
- 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.
exenatideDrug
5mg twice daily for 4 weeks followed by 10mg twice daily
taspoglutideDrug
10mg once weekly
taspoglutideDrug
10mg once weekly for 4 weeks followed by 20mg once weekly
| Study group | Role | What they receive |
|---|---|---|
| exenatide | Active comparator | Not described Receives: Drug: exenatide |
| taspoglutide 10mg | Experimental | Not described Receives: Drug: taspoglutide |
| taspoglutide 10mg/20mg | Experimental | Not described Receives: Drug: taspoglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Measured: 24 weeks
Secondary outcomes (4)
Fasting body weight
Measured: 24 weeks
Proportion of patients reaching target HbA1c <=7.0%, <=6.5%
Measured: 24 weeks
Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients.
Measured: 24 weeks
Beta cell function (proinsulin/insulin ratio)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- None (open label)
- Enrolment
- 1,189 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
- NCT00717457
- Sponsor's protocol ID
- BC21625
- Other IDs
- 2008-001856-36, 2008
- Status last verified
- Nov 2016
- First submitted
- 16 Jul 2008
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Rosenstock J, Balas B, Charbonnel B, Bolli GB, Boldrin M, Ratner R, Balena R; T-emerge 2 Study Group. The fate of taspoglutide, a weekly GLP-1 receptor agonist, versus twice-daily exenatide for type 2 diabetes: the T-emerge 2 trial. Diabetes Care. 2013 Mar;36(3):498-504. doi: 10.2337/dc12-0709. Epub 2012 Nov 8.
PubMed 23139373
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
- Randomized, Active Controlled, Open Label Study to Compare Taspoglutide vs Exenatide as add-on Treatment to Metformin and/or Thiazolidinediones in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00717457
- Acronym / sponsor ID
- BC21625
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,189 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 17 Jul 2008 (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 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is >500 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| exenatide | Active comparator | Drug: exenatide |
| taspoglutide 10mg | Experimental | Drug: taspoglutide |
| taspoglutide 10mg/20mg | Experimental | Drug: taspoglutide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult patients, 18-75 years of age;
- type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks;
- HbA1c >=7.0% and <=10% at screening;
- BMI >=25kg/m2 (>23kg/m2 for Asians) and <=45kg/m2 at screening;
- stable weight +/- 5% for at least 12 weeks prior to screening.
Key exclusion criteria (8 listed)
- history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes;
- history of acute metabolic diabetic complications within the previous 6 months;
- evidence of clinically significant diabetic complications;
- known proliferative diabetic retinopathy;
- myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months;
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 |
|---|---|---|
| exenatide5mg twice daily for 4 weeks followed by 10mg twice daily | Drug | exenatide |
| taspoglutide10mg once weekly | Drug | taspoglutide 10mg |
| taspoglutide10mg once weekly for 4 weeks followed by 20mg once weekly | Drug | taspoglutide 10mg/20mg |
Primary outcome
Change in HbA1c
Time frame: 24 weeks
4 secondary outcomes
Fasting body weight
Time frame: 24 weeks
Proportion of patients reaching target HbA1c <=7.0%, <=6.5%
Time frame: 24 weeks
Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients.
Time frame: 24 weeks
Beta cell function (proinsulin/insulin ratio)
Time frame: 24 weeks
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 23139373Rosenstock J, Balas B, Charbonnel B, Bolli GB, Boldrin M, Ratner R, Balena R; T-emerge 2 Study Group. The fate of taspoglutide, a weekly GLP-1 receptor agonist, versus twice-daily exenatide for type 2 diabetes: the T-emerge 2 trial. Diabetes Care. 2013 Mar;36(3):498-504. doi: 10.2337/dc12-0709. Epub 2012 Nov 8.
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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
216 sites in 26 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing exenatide and taspoglutide in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 216 sites in 26 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 5 inclusion and 8 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 216 sites in United States, Russia, Germany, Mexico, Israel and 21 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 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?
Change in HbA1c (time frame: 24 weeks). 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 NCT00717457, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 7 Nov 2026.