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

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

Rivoglitazone HCl

rivoglitazone HCl

Placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring rivoglitazone HCl, thiazolidinedione, peroxisome proliferator-activated receptor gamma (PPARgamma), diabetes mellitus, type 2

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

rivoglitazone HCl 0.5 mg tablets once daily for 12 weeks

rivoglitazone HCl 1 mg tablets once daily for 12 weeks

rivoglitazone HCl 1.5 mg tablets once daily for 12 weeks

Matching placebo tablets once daily for 12 weeks

Outcomes

Primary Outcome Measures

Change in HbA1c from baseline for rivoglitazone compared to placebo

Secondary Outcome Measures

Change in Fasting Plasma Glucose from baseline for rivoglitazone HCl compared to placebo

Full Information

NCT ID

NCT00575471

First Posted

December 17, 2007

Last Updated

February 27, 2009

Sponsor

Daiichi Sankyo Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00575471

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Daiichi Sankyo Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

250 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

rivoglitazone HCl 0.5 mg tablets once daily for 12 weeks

Arm Title

Arm Type

Experimental

Arm Description

rivoglitazone HCl 1 mg tablets once daily for 12 weeks

Arm Title

Arm Type

Experimental

Arm Description

rivoglitazone HCl 1.5 mg tablets once daily for 12 weeks

Arm Title

Arm Type

Placebo Comparator

Arm Description

Matching placebo tablets once daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Rivoglitazone HCl

Intervention Description

0.5 mg tablets once daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

rivoglitazone HCl

Intervention Description

1.0 mg tablets once daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

rivoglitazone HCl

Intervention Description

1.5 mg tablets once daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo tablets once daily for 12 weeks

Primary Outcome Measure Information:

Title

Change in HbA1c from baseline for rivoglitazone compared to placebo

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change in Fasting Plasma Glucose from baseline for rivoglitazone HCl compared to placebo

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

City

Fukuoka

Country

Japan

City

Osaka

Country

Japan

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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