A Titration Study of a Glucagon-Like Peptide-1 (GLP-1) Analogue in Patients With Type 2 Diabetes Treated With Metformin.
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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.
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.
Study Start Date
Primary Completion Date
Study Completion Date
Resource links provided by the National Library of Medicine
Percentage of patients withdrawn because of gastrointestinal effects [ Time Frame: Week 9 ]
Secondary Outcome Measures
Mean changes in 24h blood glucose Area Under the Curve (AUC), Fasting Plasma Glucose (FPG), fructosamine, Hemoglobin A1c (HbA1c), body weight, Adverse Events (AEs), laboratory parameters. [ Time Frame: Week 9 ]
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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;