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

NCT ID: NCT00724542

Last Updated: 2008-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Coronary Heart Disease Impaired Glucose Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control

Placebo with lifestyle intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Drug

Voglibose tablets with lifestyle intervention

Group Type EXPERIMENTAL

Voglibose tablets

Intervention Type DRUG

0.2mg Tid

Interventions

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Voglibose tablets

0.2mg Tid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role collaborator

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Peking University First Hospital

Principal Investigators

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Wenhui Ding, Professor

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenhui Ding, Professor

Role: CONTACT

Phone: 86-10-66551122

Email: [email protected]

Libin Shi

Role: CONTACT

Email: [email protected]

Facility Contacts

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Wenhui Ding, Professor

Role: primary

Other Identifiers

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2006BAI01A02-11

Identifier Type: -

Identifier Source: org_study_id