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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Ministry of Science and Technology of the People´s Republic of China.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Takeda Pharmaceutical Company Limited
Information provided by:
Ministry of Science and Technology of the People´s Republic of China
ClinicalTrials.gov Identifier:
NCT00724542
First received: July 25, 2008
Last updated: August 22, 2008
Last verified: August 2008
History of Changes
  Purpose

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.


Condition Intervention
Coronary Heart Disease
Impaired Glucose Tolerance
 Drug: Voglibose tablets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Lifestyle and Therapeutic Intervention on Impaired Glucose Tolerance(IGT) in Patients With Coronary Heart Disease.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ministry of Science and Technology of the People´s Republic of China:

Primary Outcome Measures:
  • TypeⅡDiabetes Mellitus [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Occurrence of Cardiovascular Events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1600
Study Start Date: July 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Placebo with lifestyle intervention
Experimental: Drug
Voglibose tablets with lifestyle intervention
 Drug: Voglibose tablets
0.2mg Tid

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00724542

Contacts
Contact: Wenhui Ding, Professor 86-10-66551122 ext 5001 dwh_rd@126.com
Contact: Libin Shi shlb1975@yahoo.com.cn

Locations
China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Wenhui Ding, Professor     86-10-66551122 ext 5001     dwh_rd@126.com    
Sponsors and Collaborators
Ministry of Science and Technology of the People´s Republic of China
Takeda Pharmaceutical Company Limited
Investigators
Principal Investigator: Wenhui Ding, Professor Peking University First Hospital
  More Information

No publications provided

Responsible Party: Yong Huo, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT00724542     History of Changes
Other Study ID Numbers: 2006BAI01A02-11
Study First Received: July 25, 2008
Last Updated: August 22, 2008
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Glucose Intolerance
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Voglibose
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013