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Study of Rivoglitazone in Type 2 Diabetes Mellitus

NCT00484198 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1912

Last updated 2021-07-27

Study results available
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Summary

This is a 26-week study in subjects with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. The total duration of a subject's participation will be approximately 30 weeks, including a 2-week placebo run-in period, a 26-week double-blind treatment period, and a 2-week post-treatment follow-up period.

Conditions

Interventions

DRUG

Pioglitazone

45 mg over-encapsulated tablet administered orally, once daily

DRUG

Placebo

Rivoglitazone-matching placebo administered as a tablet orally, once daily or a pioglitazone-matching placebo administered as an over-encapsulated tablet orally, once daily capsule

DRUG

Rivoglitazone

1.0 mg tablet administered orally, once daily

DRUG

Rivoglitazone

1.5 mg tablet administered orally, once daily

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-23
Primary Completion
2009-02-12
Completion
2009-02-12

Countries

  • United States
  • Argentina
  • Austria
  • Chile
  • Czechia
  • Germany
  • Hungary
  • India
  • Latvia
  • Mexico
  • Peru
  • Puerto Rico
  • Romania
  • Serbia
  • Slovakia
  • South Africa
  • Ukraine
  • United Kingdom

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 NCT00484198 on ClinicalTrials.gov