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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus Type 2

In brief

This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment. After 24 weeks of treatment, patients on active treatment will continue on the same treatment and 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 2+ years, and the target sample size is 500+ individuals.

Key facts

Study ID

NCT00754988

Run by

Hoffmann-La Roche

People needed

666

Starts

2008-10-01

Expected to finish

2011-03-01

Last updated by the study team

2016-11-04

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 (>=1500mg/day) for at least 12 weeks;
• HbA1c >=7.0% and <=10.0% at screening;
• BMI >=25 (>23 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 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 — Huntsville, Alabama, United States
• Study site — Tallassee, Alabama, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Huntington Beach, California, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Roseville, California, United States
• Study site — San Francisco, California, United States
• Study site — Tacoma, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — New London, Connecticut, United States
• Study site — Manati, District of Columbia, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Panama City, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Conyers, Georgia, United States
• Study site — Snellville, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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