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.
Status: | Completed |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 8/3/2016 |
Start Date: | July 2008 |
End Date: | March 2011 |
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
82
sites
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