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Randomized, Double-blind, Active-controlled, Study of Rivoglitazone in Type 2 Diabetes Mellitus

NCT00571519 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2021-05-26

Study results available
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Summary

This is a 26-week, multicenter, randomized, double-blind, placebo and active comparator-controlled, parallel-group study in participants with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. Pioglitazone is used as active comparator. The total duration of a participant's participation will be approximately 30 weeks, including a 2-week placebo lead-in period, a 26-week double-blind treatment period, and a 2-week post-treatment follow-up period. Participants who complete the randomized portion of the study per protocol may have the opportunity to continue in a long-term extension study of active treatments.

Conditions

Interventions

DRUG

Rivoglitazone HCl

0.5 mg tablets administered orally, once daily

DRUG

rivoglitazone HCl

1.0 mg tablets administered orally, once daily

DRUG

rivoglitazone HCl

1.5 mg tablets administered orally, once daily

DRUG

placebo

placebo tablets matching rivoglitazone tablets administered orally, once daily

DRUG

pioglitazone HCl

15 mg capsules administered orally, once daily

DRUG

pioglitazone HCl

30 mg capsules administered orally, once daily

DRUG

pioglitazone HCl 45 mg

45 mg capsules administered orally, once daily

DRUG

placebo

placebo capsules for pioglitazone administered orally, once daily

DRUG

metformin

Oral tablets. Rescue medication.

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
2007-11-14
Primary Completion
2008-05-23
Completion
2008-05-23

Countries

  • United States

Study Locations

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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 NCT00571519 on ClinicalTrials.gov