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A Study of Aleglitazar in Type 2 Diabetes Patients With Moderate Renal Impairment

NCT01043029 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2016-11-02

No results posted yet for this study

Summary

This multi-center, randomized, double-blind, active controlled, parallel-group study in type 2 diabetes patients with moderate renal impairment will evaluate the effect on renal function and the safety and tolerability of aleglitazar compared with pioglitazone. Patients will be randomized to receive either 150 mcg aleglitazar or 45 mg pioglitazone as daily oral doses. In addition, a diet and exercise plan will also be implemented during the anticipated time on study treatment of 52 weeks. The target sample size is 200-400 patients.

Conditions

  • Diabetes Mellitus Type 2

Interventions

DRUG

aleglitazar

Aleglitazar 150 mcg po daily for 52 weeks

DRUG

pioglitazone

Pioglitazone 45 mg po daily for 52 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Australia
  • Brazil
  • Colombia
  • El Salvador
  • Germany
  • Hong Kong
  • Hungary
  • Italy
  • Mexico
  • Peru
  • Romania
  • Russia
  • Slovakia

Study Locations

More Related Trials

Entities

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 NCT01043029 on ClinicalTrials.gov