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

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease; Type 2 Diabetes

Treatments: Drug: Metformin; Drug: Glipizide

Study type: Interventional

Funder types: Other

Identifiers

NCT00513630

CCEMD002

Details and patient eligibility

About

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

Enrollment: 304 patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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304 participants in 2 patient groups

metformin

Active Comparator group

Treatment:

Drug: Glipizide

glipizide

Active Comparator group

Treatment:

Drug: Metformin