(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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- Japan Foundation for the Promotion of International Medical Research Cooperation
- Enrollment
- 2542
- Locations
- 1
- Primary Endpoint
- The occurrence of myocardial infarction, coronary bypass surgery, percutaneous transluminal coronary angioplasty, stroke, carotid endarterectomy, percutaneous transluminal cerebral angioplasty, carotid artery stenting, or death
- Last Updated
- 8 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects were considered eligible if they were 45 years old or older but younger than 70 years old at study entry, had type 2 diabetes and met both "(1) and (2)" or both "(1) and (3)" described below. \[Note: Those who met all three "(1), (2) and (3)" were also considered eligible for inclusion.\](1) Glycemic control Those with HbA1c 6.9% or greater despite treatment with any of the three regimens given below. Diet and exercise therapy alone, Diet and exercise therapy plus 1 oral anti-diabetic drug, Diet and exercise therapy plus, GI and 1 other oral anti-anti-diabetic drug (2) Blood pressure control Those with the following casual blood pressure (BP) level as measured on an outpatient basis, Systolic BP 140 mmHg or diastolic BP 90 mmHg while not on an antihypertensive agent, Systolic BP 130 mmHg or diastolic BP 80 mmHg while on 1 or 2 ARB, ACEI or long-acting CCB Those receiving antihypertensive agents other than ARB, ACEI or long-acting CCB were not eligible for study entry, with the exception of those who were receiving these agents for other purposes than blood pressure lowering. (3) Lipid metabolism Those with the following fasting lipid levels while not on a lipid-lowering agent LDL-cholesterol, 120 mg/dL (as calculated by using the Friedewald formula) Triglycerides, 150 mg/dL HDL-cholesterol, \< 40 mg/dL Subjects receiving 1 lipid-lowering agent were judged eligible for study entry if they met any of the above criteria. However, care needs to be taken to ensure that those on fibrates discontinue the fibrate treatment at the start of the study when they are assigned to the intensive therapy arm.
Exclusion Criteria
- •Those with poorly controlled hypertension despite pharmacological therapy (systolic BP 200 mmHg or diastolic BP 120 mmHg)
- •Those on insulin therapy
- •Those with non-diabetic renal disease
- •Those in whom type 1 and other diabetes due to pathogenic mechanisms other than those associated with type 2 diabetes is strongly suspected
- •Those who tested anti-GAD antibody\*-positive
- •Those with LDL-cholesterol 200 mg/dL
- •Those suspected of having secondary hypertension other than renal parenchymal hypertension
- •Those suspected of having hereditary lipid disorder with a strong family history of lipid metabolic disorder
- •Those who were receiving antihypertensive agents other than ARB, ACEI, long-acting CCB, except where they were receiving these agents for other purposes than blood pressure lowering
- •Those who were receiving 3 or more antihypertensive agents (i.e., ARB, ACEI, and long-acting CCB), except where they were receiving these agents for other purposes than blood pressure lowering
Outcomes
Primary Outcomes
The occurrence of myocardial infarction, coronary bypass surgery, percutaneous transluminal coronary angioplasty, stroke, carotid endarterectomy, percutaneous transluminal cerebral angioplasty, carotid artery stenting, or death
Time Frame: Every 12 months, at the end of the study.
Secondary Outcomes
- Occurrence of myocardial infarction, stroke or death(Every 12 months, at the end of the study.)
- Onset or progression of nephropathy(Every 6 months, at the end of the study.)
- Lower limb vascular events (amputation or revascularization of lower limb)(Every 12 months, at the end of the study.)
- Onset or progression of retinopathy(Every 12 months, at the end of the study.)
- All-cause mortality (deaths due to any cause)(Every 12 months, at the end of the study.)