A Study of a 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: | February 2007 |
| End Date: | November 2007 |
A Double Blind, Placebo-controlled, Dose-ranging Study to Investigate the Effect on Glycemic Control, Safety, Pharmacokinetics and Pharmacodynamics of GLP-1 in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
11
sites
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