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A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Sulfonylurea Alone or Sulfonylurea Plus Metformin Therapy

NCT01691989 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2016-11-02

No results posted yet for this study

Summary

This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar compared with placebo when added to a sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy in patients with type 2 diabetes mellitus who are inadequately controlled with sulfonylurea alone or sulfonylurea plus metformin therapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks.

Conditions

  • Diabetes Mellitus Type 2

Interventions

DRUG

aleglitazar

150 mcg orally once a day for 26 weeks

DRUG

placebo

oral doses once a day for 26 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States
  • Argentina
  • Colombia
  • Guatemala
  • Mexico

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 NCT01691989 on ClinicalTrials.gov