Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00300976
Status:
UNKNOWN
Last Update Posted:
2017-08-03
First Post:
2006-03-08
Brief Title:
The Japan Diabetes Optimal Integrated Treatment Study for 3 Major Risk Factors of Cardiovascular Diseases
Sponsor:
Japan Foundation for the Promotion of International Medical Research Cooperation
Organization:
Japan Foundation for the Promotion of International Medical Research Cooperation
Study Overview
Official Title:
Intervention Study A Randomized Controlled Study of the Intensive Therapy and the Conventional Therapy for the Suppression of the Vascular Complications in the Type 2 Diabetic Patients Follow-up Study A Randomized Controlled Study Comparing Intensive Therapy and Conventional Therapy in the Reduction of Vascular Complications in Type 2 Diabetic Patients A Follow-up Study After Intervention
Status:
UNKNOWN
Status Verified Date:
2017-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
J-DOIT3
Brief Summary:
Intervention study The objective of the study is to confirm the superiority of the intensive therapy to the conventional therapy concerning the prevention of the incidence or exacerbation of vascular complications caused by diabetes mellitus DM by a randomized controlled study in patients with type 2 DM
Follow-up study The objective of the follow-up study is to evaluate the long-term efficacy of intensive versus conventional therapy in the effect on mortality and the prevention of the incidence or exacerbation of vascular complications caused by diabetes mellitus through a post-intervention follow-up research conducted after the multi-center open-label randomized parallel-group study comparing the efficacy of intensive versus conventional therapy in type 2 diabetic patients
Follow-up study The objective of the follow-up study is to evaluate the long-term efficacy of intensive versus conventional therapy in the effect on mortality and the prevention of the incidence or exacerbation of vascular complications caused by diabetes mellitus through a post-intervention follow-up research conducted after the multi-center open-label randomized parallel-group study comparing the efficacy of intensive versus conventional therapy in type 2 diabetic patients
Detailed Description:
Intervention study The objective of the study is to confirm the superiority of the intensive therapy to the conventional therapy concerning the prevention of the incidence or exacerbation of vascular complications caused by diabetes mellitus by a randomized controlled study in patients with type 2 DM The primary outcome measure is occurrence of myocardial infarction coronary bypass surgery percutaneous transluminal coronary angioplasty stroke carotid endarterectomy percutaneous transluminal cerebral angioplasty carotid artery stenting or death
Follow-up study The objective of the follow-up study is to evaluate the long-term efficacy of intensive versus conventional therapy in the effect on mortality and the prevention of the incidence or exacerbation of vascular complications caused by diabetes mellitus through a post-intervention follow-up research conducted after the multi-center open-label randomized parallel-group study comparing the efficacy of intensive versus conventional therapy in type 2 diabetic patients The primary endpoint is identical to that in the intervention study In addition overall survivalall-cause mortality will be evaluated as a key secondary endpoint
Follow-up study The objective of the follow-up study is to evaluate the long-term efficacy of intensive versus conventional therapy in the effect on mortality and the prevention of the incidence or exacerbation of vascular complications caused by diabetes mellitus through a post-intervention follow-up research conducted after the multi-center open-label randomized parallel-group study comparing the efficacy of intensive versus conventional therapy in type 2 diabetic patients The primary endpoint is identical to that in the intervention study In addition overall survivalall-cause mortality will be evaluated as a key secondary endpoint
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None