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CompletedNCT00513630SPREADDIMCADUpdated Apr 26, 2011

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

A Phase 4 interventional study of Glipizide and Metformin in Type 2 Diabetes and Coronary Artery Disease, sponsored by Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2011-04-26.

Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
304
Allocation
Randomized
Ages
Up to 80 Years
Sex
All
01

Study 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
02

Conditions studied

03

In context

Coronary Artery Disease

5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's enrollment of 304 is above the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Coronary heart disease
  • Type 2 diabetes

Exclusion criteria

Exclusion Criteria:

  • Severe organ dysfunction, psychopathy, infection, neutropenia
  • Congenital heart disease, rheumatic heart disease, severe arrhythmia, myocardiopathy
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
304 participants (actual)

Study arms

  • Active comparator
    metformin

    Drug: Glipizide

  • Active comparator
    glipizide

    Drug: Metformin

Interventions

  • DrugGlipizide
  • DrugMetformin
06

What researchers measure

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

  1. New or worsening angina

  2. new or worsening heart failure

  3. new critical cardiac arrhythmia

  4. new peripheral vascular events

07

Study locations

1 site
  • Shanghai Jiao Tong University School of Medicine
    Shanghai, 200025, China
08

References and documents

Publications

  • 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. PubMed 23230096 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00513630
Lead sponsor
Shanghai Jiao Tong University School of Medicine
First posted
Aug 8, 2007
Start date
Jun 2004
Primary completion
Jul 2010
Completion
Jul 2010
Last update
Apr 26, 2011

Study contacts

Guang Ning, MD. PHD
principal investigator · Shanghai Jiao Tong University School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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