NCT00724542

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 25, 2008

Status Verified

August 1, 2008

Enrollment Period

2.4 years

First QC Date

July 25, 2008

Last Update Submit

August 22, 2008

Conditions

Coronary Heart DiseaseImpaired Glucose Tolerance

Outcome Measures

Primary Outcomes (1)

  • TypeⅡDiabetes Mellitus

    2 years

Secondary Outcomes (1)

  • Occurrence of Cardiovascular Events

    2 years

Study Arms (2)

Control

NO INTERVENTION

Placebo with lifestyle intervention

Drug

EXPERIMENTAL

Voglibose tablets with lifestyle intervention

Drug: Voglibose tablets

Interventions

Voglibose tabletsDRUG

0.2mg Tid

Drug

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with coronary heart disease
  • Impaired Glucose Tolerance

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Coronary DiseaseGlucose Intolerance

Interventions

voglibose

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesHyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Wenhui Ding, Professor

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenhui Ding, Professor

CONTACT

86-10-66551122dwh_rd@126.com

Libin Shi

CONTACT

shlb1975@yahoo.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 25, 2008

First Posted

July 29, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

August 25, 2008

Record last verified: 2008-08

Locations

CN(1)