This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel group, fixed dose study. AMG 151 will be evaluated in subjects with type 2 diabetes treated with metformin for at least 3 months prior to randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
236
To evaluate the dose-effect relationship of AMG 151 compared to placebo on fasting plasma glucose in subjects with type 2 diabetes treated with metformin
Time frame: Change in fasting plasma glucose levels from baseline to Day 28
To assess the effect of AMG 151 on postprandial glucose levels in response to a meal tolerance test
Time frame: Change in area under the curve from 0-4 hours (AUC0-4hr) glucose after a meal tolerancetest from baseline to Day 28, Change in incremental AUC0-4hr glucose after a meal tolerance test from baseline to Day 28
Adverse events
Time frame: Incidence of serious adverse events from signing of ICF to Day 42. Incidence of non-serious adverse events from randomization to Day 42.
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Drug: AMG 151 100 mg BID
Drug: AMG 151 200 mg BID
Drug: AMG 151 100 mg QD
Drug: AMG 151 200 mg QD
Drug: AMG 151 400 mg QD
Research Site
Birmingham, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Anaheim, California, United States
Research Site
Chula Vista, California, United States
Research Site
Fresno, California, United States
Research Site
Greenbrae, California, United States
Research Site
Inglewood, California, United States
Research Site
Lomita, California, United States
...and 67 more locations