A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus Type 2

In brief

This 2 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy. Patients will be randomized to receive taspoglutide (10mg sc once weekly for 4 weeks followed by 20mg once weekly) or placebo sc, in addition to their prescribed, pre-existing metformin therapy.After the first 24 weeks, patients on placebo will be switched to taspoglutide 20mg once weekly (after 4 weeks on taspoglutide 10mg once weekly) The anticipated time on study treatment is 12 months, and the target sample size is 100-500 individuals.

Key facts

Study ID

NCT00823992

Run by

Hoffmann-La Roche

People needed

305

Starts

2009-01-01

Expected to finish

2010-05-01

Last updated by the study team

2016-07-28

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 mellitus, receiving metformin at a stable dose of >=1500mg/day for at least 12 weeks;
• HbA1c >=6.5% and <=9.5% at screening;
• BMI >=30 and <=50 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 or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months;
• evidence of clinically significant diabetic complications;
• myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the past 6 months.

Where it is running

• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Mission Viejo, California, United States
• Study site — Brooksville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Avon, Indiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Bangor, Maine, United States
• Study site — Royal Oak, Michigan, United States
• Study site — Picayune, Mississippi, United States
• Study site — Clifton, New Jersey, United States
• Study site — Toms River, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — New York, New York, United States
• Study site — Springfield Gardens, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Shelby, North Carolina, United States
• Study site — Norman, Oklahoma, United States
• Study site — Medford, Oregon, United States
• Study site — Clinton, South Carolina, United States
• Study site — Kingsport, Tennessee, United States
• Study site — Bermuda Dunes, California, United States

Full record on ClinicalTrials.gov

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