A Titration Study of a Glucagon-Like Peptide-1 (GLP-1) Analogue in Patients With Type 2 Diabetes Treated With Metformin.

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus Type 2

In brief

This 4 arm study will evaluate the tolerability, efficacy and pharmacodynamics of different doses of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue (at a dose of 20mg, or a starting dose of 20mg escalating to either 30mg or 40mg), weekly. All patients will continue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.

Key facts

Study ID

NCT00460941

Run by

Hoffmann-La Roche

People needed

133

Starts

2007-04-01

Expected to finish

2008-01-01

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…

• male,and post-menopausal or surgically sterilized female, patients, 18-75 years of age;
• type 2 diabetes mellitus, with stable metformin treatment for >=3 months;
• HbA1c >=7.0% and <=9.5% at screening;
• stable weight +/-10% for >=3 months before screening.

You may not qualify if…

• type 1 diabetes mellitus;
• clinically significant gastrointestinal disease;
• treatment with any anti-hyperglycemic medication other than metformin monotherapy during last 3 months;
• use of weight-lowering medications in the last 3 months;
• uncontrolled hypertension;
• previous exposure to GLP-1 or GLP-1 analogues.

Where it is running

• Study site — Harrisburg, Arkansas, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — National City, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Madisonville, Kentucky, United States
• Study site — Hyattsville, Maryland, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Dallas, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Richmond, Virginia, United States
• Study site — Adelaide, Australia
• Study site — Camperdown, Australia
• Study site — Besançon, France
• Study site — Corbeil-Essonnes, France
• Study site — Narbonne, France
• Study site — Paris, France
• Study site — Poitiers, France
• Study site — Berlin, Germany
• Study site — München, Germany
• Study site — Neuss, Germany
• Study site — Chihuahua City, Mexico
• Study site — Culiacán, Mexico
• Study site — Monterrey, Mexico
• Study site — Tampico, Mexico

Full record on ClinicalTrials.gov

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