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

Status:	Completed
Conditions:	Diabetes, Diabetes
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	18 - 75
Updated:	8/3/2016
Start Date:	April 2007
End Date:	January 2008

A Double-blind, Placebo-controlled Titration Study to Investigate the Tolerability, Safety and Pharmacodynamic Profile of a GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

We found this trial at

sites

Clinical Trial Facility in Harrisburg Arkansas

Harrisburg, Arkansas 72452

from

Harrisburg, AR