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

Condition(s) targeted: Type 2 Diabetes; Coronary Artery Disease

Intervention: Glipizide (Drug); Metformin (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Shanghai Jiao Tong University of Medicine

Official(s) and/or principal investigator(s):
Guang Ning, MD. PHD, Principal Investigator, Affiliation: Shanghai Jiao Tong University School of Medicine

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

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

the recurrence rate and severity of cardiovascular event

the incidence and severity of restenosis and second infarction confirmed by coronary artery achieving CAG

Secondary outcome:

plasma glucose (fasting and postprandial)levels, HbA1c, lipid levels ,body weight, blood pressure

the incidence of other diabetic chronic complication

Minimum age: N/A. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China

Starting date: June 2004
Ending date: July 2010
Last updated: August 7, 2007