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Sponsored by: |
Japan Foundation for the Promotion of International Medical Research Cooperation |
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Information provided by: | Japan Foundation for the Promotion of International Medical Research Cooperation |
ClinicalTrials.gov Identifier: | NCT00300976 |
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.
Condition | Intervention |
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Cardiovascular Diseases Diabetes Mellitus, Type 2 |
Behavioral: Lifestyle consultation: weight control, diet, exercise Drug: Thiazolidine derivatives, biguanides Drug: Insulin-secreting drugs, alpha-glucosidase inhibitors Drug: Angiotensin II receptor antagonists Drug: Angiotensin converting enzyme inhibitors Drug: Atorvastatin, pitavastatin, eicosapentaenic acid |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 3000 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | December 2009 |
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 the incidence of myocardial infarction, stroke, or death.
Ages Eligible for Study: | 45 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Type 2 diabetic patients aged 45 years or more and less than 70 years when their consent is obtained, who meet "both (1) and (2)" or "both (1) and (3)" of the following criteria. Patients who meet all (1), (2), and (3) are also included as subjects.
Glucose level: Patients with hemoglobin A1c (HbA1c) of 7.0% or higher, who are on treatment with some of the following treatments:
Blood pressure (BP): Patients meeting some of the following conditions of casual BP at the time of the ambulatory practice:
Patients who are on treatment with anti-hypertensive drugs other than angiotensin II receptor blockers, angiotensin converting enzyme inhibitors, and long-acting Ca channel blockers are excluded as subjects. This rule, however, does not apply in the case in which these anti-hypertensive drugs are administered for other purposes.
Lipid metabolism: Patients meeting some of the following 3 conditions of fasting levels without use of medication for the treatment of hyperlipemia:
Even in the case of the use of only 1 medication for the treatment of hyperlipemia, patients meeting any of the above-described criteria may be included in the study. However, fibrates need to be withdrawn at the start of the study in patients who are on an oral medication consisting of 1 fibrate and allocated to the intensive therapy group.
Exclusion Criteria:
Patients with BNP >= 100 pg/mL, who meet some of the following conditions:
Contact: Takashi Kadowaki, MD, PhD | +81-3-5800-8815 | kadowaki-3im@h.u-tokyo.ac.jp |
Japan | |
The University of Tokyo | Recruiting |
Tokyo, Japan, 113-8655 | |
Contact: Takashi Kadowaki, MD +81-3-5800-8815 kadowaki-3im@h.u-tokyo. ac.jp | |
Principal Investigator: Takashi Kadowaki, MD |
Principal Investigator: | Toshitsugu Oda | The Japan Foundation for the Promotion of International Medical Research Cooperation |
Study ID Numbers: | J-DOIT3 |
Study First Received: | March 8, 2006 |
Last Updated: | March 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00300976 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Blood glucose Blood pressure Lipids |
Antimetabolites Metabolic Diseases Antilipemic Agents Diabetes Mellitus Endocrine System Diseases Anticholesteremic Agents Cardiovascular Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Angiotensin II Insulin |
Protease Inhibitors NK 104 Diabetes Mellitus, Type 2 Vasoconstrictor Agents Angiotensin-Converting Enzyme Inhibitors Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Atorvastatin |
Antimetabolites Metabolic Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Diabetes Mellitus Endocrine System Diseases Enzyme Inhibitors Anticholesteremic Agents Cardiovascular Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Angiotensin II |
Pharmacologic Actions Protease Inhibitors NK 104 Therapeutic Uses Diabetes Mellitus, Type 2 Vasoconstrictor Agents Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Glucose Metabolism Disorders Atorvastatin |