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

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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.


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.
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