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

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

This study has been completed.

First Received on August 7, 2007. Last Updated on April 25, 2011 History of Changes

Sponsor:	Shanghai Jiao Tong University School of Medicine
Information provided by:	Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:	NCT00513630

Purpose

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:

follow up 3yr
recurrence of cardiovascular event
death caused by other reasons such as stroke, uremia, blindness and amputation

Condition	Intervention	Phase
Type 2 Diabetes Coronary Artery Disease	Drug: Glipizide Drug: Metformin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Coronary Artery Disease Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Glipizide Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:

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:

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

Enrollment:	304
Study Start Date:	June 2004
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: metformin	Drug: Glipizide
Active Comparator: glipizide	Drug: Metformin

Eligibility

Ages Eligible for Study:	up to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513630

Locations

China
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

More Information

No publications provided

Responsible Party:	Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:	NCT00513630 History of Changes
Other Study ID Numbers:	CCEMD002
Study First Received:	August 7, 2007
Last Updated:	April 25, 2011
Health Authority:	China: Ethics Committee

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glipizide
Hypoglycemic Agents
Metformin
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012