Placebo Controlled Dose-Response Study of Rivoglitazone in Type 2 Diabetes

A Randomized, Double-Blind, Placebo-Controlled 12-Week Dose-Response Study of Rivoglitazone (CS-011) in Patients With Type 2 Diabetes.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00575471

Enrollment

250

Registered

2007-12-18

Start date

2007-07-31

Completion date

2008-03-31

Last updated

2009-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

rivoglitazone HCl, thiazolidinedione, peroxisome proliferator-activated receptor gamma (PPARgamma), diabetes mellitus, type 2

Brief summary

The purpose of this study is to assess the efficacy response of rivoglitazone HCl on the change in HbA1c after 12 weeks of treatment in patients with type 2 diabetes.

Interventions

DRUGRivoglitazone HCl

0.5 mg tablets once daily for 12 weeks

DRUGrivoglitazone HCl

1.0 mg tablets once daily for 12 weeks

DRUGPlacebo

Matching placebo tablets once daily for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

* type 2 diabetes mellitus * HbA1c \>6.5% and \<10% * FPG \>126 mg/dL (7mmol/L) and \<270 mg/dL (15 mmol/L)

Exclusion criteria

* history of type 1 diabetes * history of ketoacidosis * current insulin therapy * C-peptide \<0.5ng/mL * impaired hepatic function * CHF or history of CHF (NYHA stage I - IV) * uncontrolled hypertension

Design outcomes

Primary

Measure	Time frame
Change in HbA1c from baseline for rivoglitazone compared to placebo	12 weeks

Secondary

Measure	Time frame
Change in Fasting Plasma Glucose from baseline for rivoglitazone HCl compared to placebo	12 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026