Study on the Prognosis and Effect of Anti-diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease
Overview[ - collapse ][ - ]
| Purpose | 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 |
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| Condition | Type 2 Diabetes Coronary Artery Disease |
| Intervention | Drug: Glipizide Drug: Metformin |
| Phase | Phase 4 |
| Sponsor | Shanghai Jiao Tong University School of Medicine |
| Responsible Party | Shanghai Jiao Tong University School of Medicine |
| ClinicalTrials.gov Identifier | NCT00513630 |
| First Received | August 7, 2007 |
| Last Updated | April 25, 2011 |
| Last verified | December 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 7, 2007 |
|---|---|
| Last Updated Date | April 25, 2011 |
| Start Date | June 2004 |
| Estimated Primary Completion Date | July 2010 |
| Current 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 |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Study on the Prognosis and Effect of Anti-diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease |
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| Official Title | 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: 1. follow up 3yr 2. recurrence of cardiovascular event 3. death caused by other reasons such as stroke, uremia, blindness and amputation |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: Glipizide Drug: Metformin |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 304 |
| Estimated Completion Date | July 2010 |
| Estimated Primary Completion Date | July 2010 |
| 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 |
| Gender | Both |
| Ages | N/A |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | China |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00513630 |
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| Other Study ID Numbers | CCEMD002 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Shanghai Jiao Tong University School of Medicine |
| Study Sponsor | Shanghai Jiao Tong University School of Medicine |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Guang Ning, MD. PHD Shanghai Jiao Tong University School of Medicine |
| Verification Date | December 2010 |
Locations[ + expand ][ + ]
| Shanghai Jiao Tong University School of Medicine | Shanghai, China, 200025 |
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