A Study of a GLP-1 Analogue in Patients With Type 2 Diabetes Treated With Metformin.

Summary

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.

Timeline

Start

2007-02

Primary completion

2007-11

Completion

2007-11

Outcome

Met primary endpoint

paper Significantly greater (P < 0.0001) reductions in A1C from a mean +/- SD baseline of 7.9 +/- 0.7% were observed in all taspoglutide groups PMID 19366970 ↗

paper -1.0 +/- 0.1% (20 mg Q2W) vs. -0.2 +/- 0.1% with placebo. PMID 19366970 ↗

Publications

• Nauck MA, Ratner RE, Kapitza C, Berria R, Boldrin M, Balena R. Treatment with the human once-weekly glucagon-like peptide-1 analog taspoglutide in combination with metformin improves glycemic control and lowers body weight in patients with type 2 diabetes inadequately controlled with metformin alone: a double-blind placebo-controlled study. Diabetes Care. 2009 Jul;32(7):1237-43. doi: 10.2337/dc08-1961. Epub 2009 Apr 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	taspoglutide	Peptide	5 mg	Subcutaneous
Subject	taspoglutide	Peptide	10 mg	Subcutaneous
Subject	taspoglutide	Peptide	20 mg	Subcutaneous

Indications