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Clinical Trials/NCT00513630
NCT00513630
Completed
Phase 4

Phase 4 Study on the Prognosis and Effect of Anti-diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease

Shanghai Jiao Tong University School of Medicine1 site in 1 country304 target enrollmentJune 2004

Overview

Phase
Phase 4
Intervention
Glipizide
Conditions
Type 2 Diabetes
Sponsor
Shanghai Jiao Tong University School of Medicine
Enrollment
304
Locations
1
Primary Endpoint
Composite of cardiovascular events which were defined as death from a cardiovascular cause, death from any cause, nonfatal myocardial infarction, nonfatal stroke or arterial revascularization
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

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
Registry
clinicaltrials.gov
Start Date
June 2004
End Date
July 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shanghai Jiao Tong University School of Medicine

Eligibility Criteria

Inclusion Criteria

  • Coronary heart disease
  • Type 2 diabetes

Exclusion Criteria

  • Severe organ dysfunction, psychopathy, infection, neutropenia
  • Congenital heart disease, rheumatic heart disease, severe arrhythmia, myocardiopathy

Arms & Interventions

metformin

Intervention: Glipizide

glipizide

Intervention: Metformin

Outcomes

Primary Outcomes

Composite of cardiovascular events which were defined as death from a cardiovascular cause, death from any cause, nonfatal myocardial infarction, nonfatal stroke or arterial revascularization

Secondary Outcomes

  • New or worsening angina
  • new or worsening heart failure
  • new critical cardiac arrhythmia
  • new peripheral vascular events

Study Sites (1)

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