Study on the Prognosis and Effect of Anti-diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease
SPREADDIMCAD
Phase 4 Study on the Prognosis and Effect of Anti-diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease
1 other identifier
interventional
304
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 type-2-diabetes
Started Jun 2004
Longer than P75 for phase_4 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 7, 2007
CompletedFirst Posted
Study publicly available on registry
August 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedApril 26, 2011
December 1, 2010
6.1 years
August 7, 2007
April 25, 2011
Conditions
Outcome Measures
Primary Outcomes (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 Outcomes (4)
New or worsening angina
new or worsening heart failure
new critical cardiac arrhythmia
new peripheral vascular events
Study Arms (2)
metformin
ACTIVE COMPARATORglipizide
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Coronary heart disease
- Type 2 diabetes
You may not qualify if:
- Severe organ dysfunction, psychopathy, infection, neutropenia
- Congenital heart disease, rheumatic heart disease, severe arrhythmia, myocardiopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Jiao Tong University School of Medicine
Shanghai, 200025, China
Related Publications (1)
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.
PMID: 23230096DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guang Ning, MD. PHD
Shanghai Jiao Tong University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 7, 2007
First Posted
August 8, 2007
Study Start
June 1, 2004
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
April 26, 2011
Record last verified: 2010-12