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

• Sponsor: Shanghai Jiao Tong University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00513630
• Collaborator: (none)
• Enrollment: 304
• Location: 1
• Arms: 2
• Duration (Months): 73
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes; Coronary Artery Disease	Drug: Glipizide; Drug: Metformin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 304 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Phase 4 Study on the Prognosis and Effect of Anti-diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease
• Study Start Date: Jun 1, 2004
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: metformin	Drug: Glipizide
Active Comparator: glipizide	Drug: Metformin

Outcome Measures

Primary Outcome Measures

1. 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

1. New or worsening angina []

2. new or worsening heart failure []

3. new critical cardiac arrhythmia []

4. new peripheral vascular events []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Jiao Tong University School of Medicine	Shanghai		China	200025

Sponsors and Collaborators

• Shanghai Jiao Tong University School of Medicine

Investigators

• Principal Investigator: Guang Ning, MD. PHD, Shanghai Jiao Tong University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00513630
• Other Study ID Numbers: CCEMD002
• First Posted: Aug 8, 2007
• Last Update Posted: Apr 26, 2011
• Last Verified: Dec 1, 2010

• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2; Metformin; Glipizide

Study Results

No Results Posted as of Apr 26, 2011