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.

Completed · Phase 3

Conditions studied: Diabetes Mellitus Type 2

In brief

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.

Key facts

Study ID

NCT00717457

Run by

Hoffmann-La Roche

People needed

1189

Starts

2008-07-01

Expected to finish

2011-03-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Montgomery, Alabama, United States
• Study site — Tuscaloosa, Alabama, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Escondido, California, United States
• Study site — La Jolla, California, United States
• Study site — Mission Viejo, California, United States
• Study site — Orange, California, United States
• Study site — Palm Springs, California, United States
• Study site — Rancho Cucamonga, California, United States
• Study site — Sacramento, California, United States
• Study site — San Leandro, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Green Cove Springs, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami Beach, Florida, United States
• Study site — Niceville, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Suwanee, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Haleyville, Alabama, United States

Full record on ClinicalTrials.gov

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