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

NCT ID: NCT00513630

Last Updated: 2011-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2010-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Type 2 Diabetes Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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metformin

Group Type ACTIVE_COMPARATOR

Glipizide

Intervention Type DRUG

glipizide

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Interventions

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Glipizide

Intervention Type DRUG

Metformin

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Shanghai Jiao Tong University School of Medicine

Principal Investigators

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Guang Ning, MD. PHD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Locations

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Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 23230096 (View on PubMed)

Other Identifiers

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CCEMD002

Identifier Type: -

Identifier Source: org_study_id

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