Study Complete
Sponsor ID
20100761

AMG 151 Amgen Protocol Number 20100761

Sponsor ID
20100761
Clinicaltrials.gov ID
NCT01464437
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 2
Product
AMG 151
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
236
Additional Study Details

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
Status
Contact Us
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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