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

August 7, 2007
April 25, 2011
June 2004
July 2010   (final data collection date for primary outcome measure)
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
  • the recurrence rate and severity of cardiovascular event
  • the incidence and severity of restenosis and second infarction confirmed by coronary artery achieving CAG
Complete list of historical versions of study NCT00513630 on ClinicalTrials.gov Archive Site
  • New or worsening angina
  • new or worsening heart failure
  • new critical cardiac arrhythmia
  • new peripheral vascular events
  • plasma glucose (fasting and postprandial)levels, HbA1c, lipid levels ,body weight, blood pressure
  • the incidence of other diabetic chronic complication
Not Provided
Not Provided
 
Study on the Prognosis and Effect of Anti-diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease
Phase 4 Study on the Prognosis and Effect of Anti-diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease

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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Coronary Artery Disease
  • Drug: Glipizide
  • Drug: Metformin
  • Active Comparator: metformin
    Intervention: Drug: Glipizide
  • Active Comparator: glipizide
    Intervention: Drug: Metformin
Hong J, Zhang Y, Lai S, Lv A, Su Q, Dong Y, Zhou Z, Tang W, Zhao J, Cui L, Zou D, Wang D, Li H, Liu C, Wu G, Shen J, Zhu D, Wang W, Shen W, Ning G; SPREAD-DIMCAD Investigators. Effects of metformin versus glipizide on cardiovascular outcomes in patients with type 2 diabetes and coronary artery disease. Diabetes Care. 2013 May;36(5):1304-11. doi: 10.2337/dc12-0719. Epub 2012 Dec 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
304
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
up to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00513630
CCEMD002
Yes
Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine
Not Provided
Principal Investigator: Guang Ning, MD. PHD Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP