The purpose of this study is to explore the recurrence risk of cardiovascular events in patients with type 2 diabetes mellitus and coronary heart disease after different antidiabetic drug therapy (glipizide or metformin) by using an double-blind, randomized, parallel control and prospective study The end point of this study is: 1. follow up 3yr 2. recurrence of cardiovascular event 3. death...
Date First Received: August 7, 2007
Last Updated: August 7, 2007
Verified by: Shanghai Jiao Tong University of Medicine, July 2007
Clinical Trial Phase: Phase 4 | Start Date: June 2004
Overall Status: Active, not recruiting
Brief Summary
Official Title: “Phase 4 Study on the Prognosis and Effect of Anti-Diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to explore the recurrence risk of cardiovascular events in patients with type 2 diabetes mellitus and coronary heart disease after different antidiabetic drug therapy (glipizide or metformin) by using an double-blind, randomized, parallel control and prospective study
The end point of this study is:
1. follow up 3yr
2. recurrence of cardiovascular event
3. death caused by other reasons such as stroke, uremia, blindness and amputation
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Glipizide
- Drug: Metformin
Outcome Measures for this Clinical Trial
Primary Measures
- the recurrence rate and severity of cardiovascular event
- the incidence and severity of restenosis and second infarction confirmed by coronary artery achieving CAG
Secondary Measures
- plasma glucose (fasting and postprandial)levels, HbA1c, lipid levels ,body weight, blood pressure
- the incidence of other diabetic chronic complication
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Coronary heart disease confirmed by CAG
- Type 2 diabetes
Exclusion Criteria:
- Severe organ dysfunction, psychopathy, infection, neutropenia
- Congenital heart disease, rheumatic heart disease, severe arrhythmia, myocardiopathy
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: 80 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Shanghai Jiao Tong University of Medicine
Overall Clinical Trial Officials and Contacts
Guang Ning, MD. PHD Principal Investigator Shanghai Jiao Tong University, School of Medicine
Additional Information
Information obtained from ClinicalTrials.gov on August 27, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00513630
Study ID Number: CCEMD002
ClinicalTrials.gov Identifier: NCT00513630
Health Authority: China: Ethics Committee
Clinical Trials Authorship and Review
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