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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.
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT00513630
First received: August 7, 2007
Last updated: April 25, 2011
Last verified: December 2010
History of Changes
  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:

  1. follow up 3yr
  2. recurrence of cardiovascular event
  3. 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 4

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:

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 by Shanghai Jiao Tong University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 June 18, 2013