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

Tracking Information

First Received Date ^ICMJE

August 7, 2007

Last Updated Date

October 13, 2009

Start Date ^ICMJE

June 2004

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

the recurrence rate and severity of cardiovascular event
the incidence and severity of restenosis and second infarction confirmed by coronary artery achieving CAG

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00513630 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

plasma glucose (fasting and postprandial)levels, HbA1c, lipid levels ,body weight, blood pressure
the incidence of other diabetic chronic complication

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Phase 4 Study on the Prognosis and Effect of Anti-diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Type 2 Diabetes
Coronary Artery Disease

Intervention ^ICMJE

Drug: Glipizide
Drug: Metformin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

July 2010

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Coronary heart disease confirmed by CAG
Type 2 diabetes

Exclusion Criteria:

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

Gender

Both

Ages

up to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT ID ^ICMJE

NCT00513630

Responsible Party

Study ID Numbers ^ICMJE

CCEMD002

Study Sponsor ^ICMJE

Shanghai Jiao Tong University School of Medicine

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Guang Ning, MD. PHD

Shanghai Jiao Tong University School of Medicine

Information Provided By

Shanghai Jiao Tong University School of Medicine

Verification Date

October 2009

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