Placebo Controlled Dose-Response Study of Rivoglitazone i... | NCT00575471

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

NCT00575471

Sponsor

Daiichi Sankyo Co., Ltd.

Status

Completed

Last Update Posted

Mar 2, 2009Estimated

Enrollment

250Actual

Phase

Phase 2

Conditions

Type 2 Diabetes

Interventions

Rivoglitazone HCl
rivoglitazone HCl
rivoglitazone HCl
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Mar 2008Actual

Completion Date

Mar 2008Actual

First Submitted Date

Dec 17, 2007

First Submission Date that Met QC Criteria

Dec 17, 2007

First Posted Date

Dec 18, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2009

Last Update Posted Date

Mar 2, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	rivoglitazone HCl 0.5 mg tablets once daily for 12 weeks	Drug: Rivoglitazone HCl
2	Experimental	rivoglitazone HCl 1 mg tablets once daily for 12 weeks	Drug: rivoglitazone HCl
3	Experimental	rivoglitazone HCl 1.5 mg tablets once daily for 12 weeks	Drug: rivoglitazone HCl
4	Placebo Comparator	Matching placebo tablets once daily for 12 weeks	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rivoglitazone HCl	Drug	0.5 mg tablets once daily for 12 weeks	1
rivoglitazone HCl

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
C563733	Carotid Intimal Medial Thickness 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Fukuoka			Japan