A Study of a 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 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple doses and regimens 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, 5mg, 10mg or 20mg weekly, or 10mg or 20mg every 2 weeks. 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

NCT00423501

Run by

Hoffmann-La Roche

People needed

306

Starts

2007-02-01

Expected to finish

2007-11-01

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…

• adult patients, 18-75 years of age;
• type 2 diabetes mellitus, with stable metformin treatment for >=3 months;
• stable weight +/-10% for >=3 months before screening.

You may not qualify if…

• type 1 diabetes mellitus;
• 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.

Where it is running

• Study site — Washington D.C., District of Columbia, United States
• Study site — Woodstock, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Springfield, Illinois, United States
• Study site — Rochester, New York, United States
• Study site — Portland, Oregon, United States
• Study site — Dallas, Texas, United States
• Study site — Midland, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Richmond, Virginia, United States
• Study site — Adelaide, Australia
• Study site — Camperdown, Australia
• Study site — Dimitrovgrad, Bulgaria
• Study site — Pleven, Bulgaria
• Study site — Rousse, Bulgaria
• Study site — Sofia, Bulgaria
• Study site — Sofia, Bulgaria
• Study site — Varna, Bulgaria
• Study site — Bad Lauterberg im Harz, Germany
• Study site — Berlin, Germany
• Study site — Görlitz, Germany
• Study site — Hanover, Germany
• Study site — Mainz, Germany
• Study site — Neuss, Germany
• Study site — Nuremberg, Germany

Full record on ClinicalTrials.gov

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