Study Complete
Sponsor ID
20100761
AMG 151 Amgen Protocol Number 20100761
Study Details
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.
Protocol Summary
Primary Outcome Measures
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
Timeframe: Change in fasting plasma glucose levels from baseline to Day 28
Secondary Outcome Measures
To assess the effect of AMG 151 on postprandial glucose levels in response to a meal tolerance test
Timeframe: 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
Timeframe: Incidence of serious adverse events from signing of ICF to Day 42. Incidence of non-serious adverse events from randomization to Day 42.
Study Documents
Study Synopsis
Available Language(s): English
Locations
Location
Research Site
Clearwater, FL, United States, 33756
Status
Recruiting
Location
Research Site
Bethesda, MD, United States, 20817
Status
Completed
Location
Research Site
Anaheim, CA, United States, 92801
Status
Recruiting
Location
Research Site
Tucson, AZ, United States, 85704
Status
Recruiting
Location
Research Site
Oklahoma City, OK, United States, 73112
Status
Recruiting
Location
Research Site
Raleigh, NC, United States, 27612
Status
Recruiting
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