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Placebo and Active Comparator Controlled Dose Response Study of Rivoglitazone in Type 2 Diabetes

NCT00575874 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2009-02-09

No results posted yet for this study

Summary

The purpose of the study is to assess the efficacy response of rivoglitazone HCl compared to pioglitazone HCl on the placebo-corrected change from baseline in HbA1c after 12 weeks of treatment in patients with type 2 diabetes.

Conditions

Interventions

DRUG

Rivoglitazone HCl

0.5 mg rivoglitazone HCl tablets once daily for 12 weeks

DRUG

rivoglitazone HCl

1.0 mg rivoglitazone HCl tablets once daily for 12 weeks

DRUG

rivoglitazone HCl

1.5 mg rivoglitazone HCl tablets once daily for 12 weeks

DRUG

pioglitazone HCl

30 mg capsules once daily for 12 weeks

DRUG

placebo

matching tablets or capsule once daily for 12 weeks

Sponsors & Collaborators

  • Daiichi Sankyo Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-06-30
Completion
2009-01-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT00575874 on ClinicalTrials.gov