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
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: 2,4-thiazolidinedione; Exenatide; Glucagon-Like Peptide 1; Metformin

Criteria

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.