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

Phase 4

Completed

• Conditions: Type 2 Diabetes; Coronary Artery Disease
• Interventions: Drug: Glipizide; Drug: Metformin

• Registration Number: NCT00513630
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2007-08-07
• Study First Submitted QC: 2007-08-07
• Study First Posted: 2007-08-08
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2010-12
• Last Update Submitted: 2011-04-25
• Last Update Posted: 2011-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metformin	Glipizide	-
glipizide	Metformin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
New or worsening angina
new or worsening heart failure
new critical cardiac arrhythmia
new peripheral vascular events

Trial Locations

Locations (1)

Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China