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AMG 151 Amgen Protocol Number 20100761

NCT01464437 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2014-05-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

AMG 151

Drug: AMG 151 50 mg BID

DRUG

Placebo

Placebo

DRUG

Metformin

Subjects will remain on their metformin regimen throughout the study. The metformin dose must be ≥ 850 mg/day for at least 2 months immediately prior to randomization.

DRUG

AMG 151

Drug: AMG 151 100 mg BID

DRUG

AMG 151

Drug: AMG 151 200 mg BID

DRUG

AMG 151

Drug: AMG 151 100 mg QD

DRUG

AMG 151

Drug: AMG 151 200 mg QD

DRUG

AMG 151

Drug: AMG 151 400 mg QD

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-10-31
Completion
2012-12-31

Countries

  • United States
  • Czechia
  • Estonia
  • Poland
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01464437 on ClinicalTrials.gov