Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin
NCT ID: NCT00603239
Last Updated: 2015-04-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
165 participants
INTERVENTIONAL
2008-01-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Exenatide twice daily (BID)
exenatide
subcutaneous injection, 5 mcg or 10 mcg, twice a day (BID)
Placebo
placebo
subcutaneous injection, volume equivalent to 5 mcg or 10 mcg of active drug, twice a day
Interventions
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exenatide
subcutaneous injection, 5 mcg or 10 mcg, twice a day (BID)
placebo
subcutaneous injection, volume equivalent to 5 mcg or 10 mcg of active drug, twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* If treated with a thiazolidinedione (TZD) alone, the TZD dose must have been stable for at least 120 days
* The dose of TZD must be: Rosiglitazone (≥4 mg/day) or pioglitazone (≥30 mg/day)
* The metformin dose has been stable for at least 90 days
* Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 10.0%, inclusive.
* Have a body mass index (BMI): 25 kg/m2 \< BMI \< 45 kg/m2.
Exclusion Criteria
* Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
* Have been treated with exogenous insulin for more than 1 week within the 2 months prior to screening
* Used drugs for weight loss (e.g., orlistat, rimonabant, sibutramine, or similar over-the-counter medications) within 3 months prior to screening.
* Are currently treated with any of the following excluded medications:
* Sulfonylurea or meglitinide derivatives (e.g., repaglinide or nateglinide) within 3 months prior to screening
* Alpha-glucosidase inhibitor (e.g., miglitol or acarbose) within 3 months of screening
* Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., sitagliptin or vildagliptin) within 3 months prior to screening
* Pramlintide acetate injection within 3 months prior to screening
* Drugs that directly affect gastrointestinal motility, including, but not limited to: Metoclopramide, cisapride, and chronic macrolide antibiotics
* Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding study start
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer, MD
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Concord, California, United States
Research Site
Fresno, California, United States
Research Site
Denver, Colorado, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Mogadore, Ohio, United States
Research Site
Corvallis, Oregon, United States
Research Site
New Westminster, British Columbia, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
Ajax, Ontario, Canada
Research Site
Cambridge, Ontario, Canada
Research Site
Windsor, Ontario, Canada
Research Site
Chihuahua City, Chihuahua, Mexico
Research Site
Celaya, Guanajuato, Mexico
Research Site
Mexico City, Mexico City, Mexico
Research Site
Monterrey, Nuevo León, Mexico
Research Site
Mexico City, , Mexico
Research Site
Baia Mare, , Romania
Research Site
Brasov, , Romania
Research Site
Bucharest, , Romania
Research Site
Dolj, , Romania
Research Site
Iași, , Romania
Research Site
Suceava, , Romania
Research Site
Johannesburg, , South Africa
Research Site
Pretoria, , South Africa
Countries
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References
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Liutkus J, Rosas Guzman J, Norwood P, Pop L, Northrup J, Cao D, Trautmann M. A placebo-controlled trial of exenatide twice-daily added to thiazolidinediones alone or in combination with metformin. Diabetes Obes Metab. 2010 Dec;12(12):1058-65. doi: 10.1111/j.1463-1326.2010.01251.x.
Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.
Other Identifiers
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H8O-MC-GWCG
Identifier Type: -
Identifier Source: org_study_id
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