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A Study of The Effect of Aleglitazar on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin

NCT01729403 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2016-11-02

No results posted yet for this study

Summary

This single-center, randomized, double-blind, placebo-controlled study will evaluate the effect of aleglitazar on insulin sensitivity in patients with type 2 diabetes mellitus who are inadequately controlled on metformin monotherapy. Patients will be randomized to receive either aleglitazar 150 mcg or placebo orally daily for 16 weeks, in addition to their existing dose and regimen of metformin.

Conditions

  • Diabetes Mellitus Type 2

Interventions

DRUG

aleglitazar

150 mcg orally daily, 16 weeks

DRUG

metformin

patients will continue on their existing dose and regimen of metformin (but not more than the maximum dose specified in the label)

DRUG

placebo

orally daily, 16 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
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 NCT01729403 on ClinicalTrials.gov