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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
306
Absolute change from baseline in HbAlc
Time frame: Week 8
Absolute change from baseline in FPG, fructosamine, body weight, fasting insulin, C-peptide, glucagon.
Time frame: Week 8
Changes in lipid profile
Time frame: Week 8
AEs, laboratory parameters, primary pharmacokinetic parameters
Time frame: Throughout study
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5mg sc weekly
10mg sc weekly
20mg sc every 2 weeks
Unnamed facility
Washington D.C., District of Columbia, United States
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Woodstock, Georgia, United States
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Chicago, Illinois, United States
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Springfield, Illinois, United States
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Rochester, New York, United States
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Portland, Oregon, United States
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Dallas, Texas, United States
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Midland, Texas, United States
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San Antonio, Texas, United States
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Richmond, Virginia, United States
...and 39 more locations