Study on the Prognosis and Effect of Anti-diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease (SPREADDIMCAD)
Primary Purpose
Type 2 Diabetes, Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Glipizide
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility 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
Sites / Locations
- Shanghai Jiao Tong University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
metformin
glipizide
Arm Description
Outcomes
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
Full Information
NCT ID
NCT00513630
First Posted
August 7, 2007
Last Updated
April 25, 2011
Sponsor
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00513630
Brief Title
Study on the Prognosis and Effect of Anti-diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease
Acronym
SPREADDIMCAD
Official Title
Phase 4 Study on the Prognosis and Effect of Anti-diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
follow up 3yr
recurrence of cardiovascular event
death caused by other reasons such as stroke, uremia, blindness and amputation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
304 (Actual)
8. Arms, Groups, and Interventions
Arm Title
metformin
Arm Type
Active Comparator
Arm Title
glipizide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Glipizide
Intervention Type
Drug
Intervention Name(s)
Metformin
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
New or worsening angina
Title
new or worsening heart failure
Title
new critical cardiac arrhythmia
Title
new peripheral vascular events
10. Eligibility
Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guang Ning, MD. PHD
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200025
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
23230096
Citation
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.
Results Reference
derived
Learn more about this trial
Study on the Prognosis and Effect of Anti-diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease
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