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

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ClinicalTrials.gov Identifier: NCT00513630
Recruitment Status : Completed
First Posted : August 8, 2007
Last Update Posted : April 26, 2011
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine

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 Type : Interventional  (Clinical Trial)
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 : June 2004
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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


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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 8, 2007    Key Record Dates
Last Update Posted: April 26, 2011
Last Verified: December 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Metformin
Hypoglycemic Agents
Glipizide
Physiological Effects of Drugs