This 5 arm study will assess the efficacy, pharmacokinetics, safety and tolerability of a DPP-IV inhibitor compared to placebo in patients with type 2 diabetes. Patients will be randomized to receive DPP-IV(3) at one of 4 doses (of 12.5mg and above), or placebo p.o. Patients receiving metformin before the study will continue on the same dose of metformin. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
289
Absolute change in hemoglobin A1c (HbA1c)
Time frame: Week 12
Absolute change in fasting plasma glucose (FPG), HbA1c response rate, absolute/relative change in insulin sensitivity, beta cell function, lipid profile.
Time frame: Week 12
Adverse events (AEs), vital signs, laboratory parameters.
Time frame: Throughout study
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Hot Springs, Arkansas, United States
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Concord, California, United States
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Los Angeles, California, United States
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Chicago, Illinois, United States
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Avon, Indiana, United States
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Indianapolis, Indiana, United States
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Oxon Hill, Maryland, United States
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Troy, Michigan, United States
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Omaha, Nebraska, United States
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Binghamton, New York, United States
...and 38 more locations