A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone.

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus Type 2

In brief

This 3 arm study will assess the efficacy of taspoglutide on glycemic control (as assessed by HbA1c) in patients with type 2 diabetes mellitus inadequately controlled with metformin plus pioglitazone, compared to placebo after 24 weeks of treatment. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg once weekly, taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) or placebo, in addition to their continued stable metformin plus pioglitazone treatment. After the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Key facts

Study ID

NCT00744367

Run by

Hoffmann-La Roche

People needed

326

Starts

2008-10-01

Expected to finish

2010-11-01

Last updated by the study team

2016-08-05

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 age;
• type 2 diabetes receiving pioglitazone (>= 30 mg/day) and metformin (>= 1500 mg/day) for at least 12 weeks prior to screening;
• HbA1c >=7.0% and <=10.0% at screening;
• BMI >= 25 (>23 for Asians) and <=45 kg/m2 at screening;
• stable weight +/-5% for at least 12 weeks prior to screening.

You may not qualify if…

• history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
• evidence of clinically significant diabetic complications;
• clinically symptomatic gastrointestinal disease;
• myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
• known hemoglobinopathy or chronic anemia.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Muscle Shoals, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Buena Park, California, United States
• Study site — Lancaster, California, United States
• Study site — Loma Linda, California, United States
• Study site — Rancho Cucamonga, California, United States
• Study site — Roseville, California, United States
• Study site — San Diego, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Wheat Ridge, Colorado, United States
• Study site — Hamden, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Bradenton, Florida, United States
• Study site — Chiefland, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Miami, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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