Diabetes Mellitus, Type 2 Clinical Trial
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
(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.
(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.
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