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

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ClinicalTrials.gov Identifier: NCT00724542
Recruitment Status : Unknown
Verified August 2008 by Ministry of Science and Technology of the People´s Republic of China.
Recruitment status was:  Recruiting
First Posted : July 29, 2008
Last Update Posted : August 25, 2008
Sponsor:
Collaborator:
Takeda
Information provided by:
Ministry of Science and Technology of the People´s Republic of China

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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Impaired Glucose Tolerance Drug: Voglibose tablets Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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.
Study Start Date : July 2008
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control
Placebo with lifestyle intervention
Experimental: Drug
Voglibose tablets with lifestyle intervention
Drug: Voglibose tablets
0.2mg Tid



Primary Outcome Measures :
  1. TypeⅡDiabetes Mellitus [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Occurrence of Cardiovascular Events [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Investigators
Principal Investigator: Wenhui Ding, Professor Peking University First Hospital

Responsible Party: Yong Huo, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT00724542     History of Changes
Other Study ID Numbers: 2006BAI01A02-11
First Posted: July 29, 2008    Key Record Dates
Last Update Posted: August 25, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Glucose Intolerance
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Voglibose
Hypoglycemic Agents
Physiological Effects of Drugs
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action