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.

First Received: August 7, 2007 Last Updated: October 13, 2009 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:	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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Diabetes

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:

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
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

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 School of Medicine

Investigators

Principal Investigator:

Guang Ning, MD. PHD

Shanghai Jiao Tong University School of Medicine

More Information

No publications provided

Study ID Numbers:	CCEMD002
Study First Received:	August 7, 2007
Last Updated:	October 13, 2009
ClinicalTrials.gov Identifier:	NCT00513630 History of Changes
Health Authority:	China: Ethics Committee

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Glipizide
Heart Diseases
Metabolic Diseases
Myocardial Ischemia
Physiological Effects of Drugs
Metformin
Diabetes Mellitus
Vascular Diseases

Endocrine System Diseases
Arteriosclerosis
Pharmacologic Actions
Coronary Disease
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Glucose Metabolism Disorders
Coronary Artery Disease

ClinicalTrials.gov processed this record on November 27, 2009