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 is ongoing, but not recruiting participants.

Sponsored by:	Shanghai Jiao Tong University 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

MedlinePlus related topics: Coronary Artery Disease Diabetes

Drug Information available for: Glipizide Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 4 Study on the Prognosis and Effect of Anti-Diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease

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

Primary Outcome Measures:

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 Measures:

plasma glucose (fasting and postprandial)levels, HbA1c, lipid levels ,body weight, blood pressure
the incidence of other diabetic chronic complication

Study Start Date:	June 2004
Estimated Study Completion Date:	July 2010

Eligibility

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

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

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 of Medicine

Investigators

Principal Investigator:

Guang Ning, MD. PHD

Shanghai Jiao Tong University School of Medicine

More Information

Study ID Numbers:	CCEMD002
Study First Received:	August 7, 2007
Last Updated:	August 7, 2007
ClinicalTrials.gov Identifier:	NCT00513630
Health Authority:	China: Ethics Committee

Study placed in the following topic categories:

Arterial Occlusive Diseases
Glipizide
Heart Diseases
Metabolic Diseases
Myocardial Ischemia
Metformin
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases

Ischemia
Arteriosclerosis
Coronary Disease
Diabetes Mellitus, Type 2
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009