A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.

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 to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea combination therapy. Patients will be randomized to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to continued prestudy metformin treatment. The anticipated time on study treatment is 2+ years, and the target sample size if 500+ individuals.

Key facts

Study ID

NCT00755287

Run by

Hoffmann-La Roche

People needed

1072

Starts

2008-11-01

Expected to finish

2010-12-01

Last updated by the study team

2016-07-29

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 treated with a stable dose of metformin and sulphonylurea for at least 12 weeks;
• C-peptide (fasting) >=1.0ng/mL;
• 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;
• symptomatic poorly controlled diabetes;
• 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 — Searcy, Arkansas, United States
• Study site — Concord, California, United States
• Study site — Huntington Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Gatos, California, United States
• Study site — Roseville, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Ana, California, United States
• Study site — Westlake Village, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Green Cove Springs, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Ormond Beach, Florida, United States
• Study site — Oviedo, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — Trinity, Florida, United States
• Study site — Zephyrhills, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Quincy, Illinois, United States
• Study site — Springfield, Illinois, United States
• Study site — Avon, Indiana, United States
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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