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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
133
sc weekly
sc weekly
sc weekly
sc weekly
Unnamed facility
Harrisburg, Arkansas, United States
Unnamed facility
Hot Springs, Arkansas, United States
Unnamed facility
Jonesboro, Arkansas, United States
Unnamed facility
National City, California, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Madisonville, Kentucky, United States
Unnamed facility
Hyattsville, Maryland, United States
Unnamed facility
Winston-Salem, North Carolina, United States
Unnamed facility
Dallas, Texas, United States
Unnamed facility
Dallas, Texas, United States
...and 19 more locations
Percentage of patients withdrawn because of gastrointestinal effects
Time frame: Week 9
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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