Evaluation of Intervention on Impaired Glucose Tolerance(... | NCT00724542

Studies
Evaluation of Intervention on Impaired Glucose Tolerance(IGT) in Patients With Coronary Heart Disease.

NCT00724542

Sponsor

Ministry of Science and Technology of the People´s Republic of China

Status

Unknown status

Last Update Posted

Aug 25, 2008Estimated

Enrollment

1,600Estimated

Phase

Not Applicable

Conditions

Coronary Heart Disease
Impaired Glucose Tolerance

Interventions

Voglibose tablets

Countries

China

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

Aug 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Jul 25, 2008

First Submission Date that Met QC Criteria

Jul 28, 2008

First Posted Date

Jul 29, 2008Estimated

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

Aug 22, 2008

Last Update Posted Date

Aug 25, 2008Estimated

Name	Class
Takeda	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 determine whether therapeutic intervention on impaired glucose tolerance in patients with coronary heart disease can decrease the incidence of new onset DM.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Placebo with lifestyle intervention
Drug	Experimental	Voglibose tablets with lifestyle intervention	Drug: Voglibose tablets

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Voglibose tablets	Drug	0.2mg Tid	Drug

Measure	Description	Time Frame
TypeⅡDiabetes Mellitus		2 years

Measure	Description	Time Frame
Occurrence of Cardiovascular Events		2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with coronary heart disease
Impaired Glucose Tolerance

Exclusion Criteria:

Age < 40yr or > 75yr
Diabetes Mellitus
Scr > 2.0 mg/dL（176 μmol/L）
ALT or AST > 2.5 ULN
Hb < 90g/L
Heart Failure
Infection
Undergo other interventional clinical trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wenhui Ding, Professor	Contact	86-10-66551122	5001	dwh_rd@126.com
Libin Shi	Contact			shlb1975@yahoo.com.cn

Overall Officials

Name	Affiliation	Role
Wenhui Ding, Professor	Peking University First Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University First Hospital	Recruiting	Beijing	Beijing Municipality	100034	China

Condition Browse Module

MeSH Terms

ID	Term
D003327	Coronary Disease
D018149	Glucose Intolerance

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C102817	voglibose

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided