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Japan Diabetes Optimal Integrated Treatment Study for 3 Major Risk Factors of Cardiovascular Diseases (J-DOIT3)
This study is currently recruiting participants.
Verified by Japan Foundation for the Promotion of International Medical Research Cooperation, July 2006
First Received: March 8, 2006   Last Updated: March 15, 2007   History of Changes
Sponsored by: Japan Foundation for the Promotion of International Medical Research Cooperation
Information provided by: Japan Foundation for the Promotion of International Medical Research Cooperation
ClinicalTrials.gov Identifier: NCT00300976
  Purpose

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
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

MedlinePlus related topics: Diabetes Diets
Drug Information available for: Insulin Angiotensin II Atorvastatin Atorvastatin calcium Pitavastatin NK 104 Angiotensin II, ile(5)-
U.S. FDA Resources
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

Further study details as provided by Japan Foundation for the Promotion of International Medical Research Cooperation:

Primary Outcome Measures:
  • Incidence of myocardial infarction
  • Incidence of stroke
  • Incidence of death (it does not matter what the cause of death is)

Secondary Outcome Measures:
  • Incidence or exacerbation of nephropathy
  • Large vessel complications: Coronary artery events (bypass operation of the coronary artery, percutaneous coronary revascularization)
  • Cerebral artery events (cerebral revascularization for blood circulation, cerebral revascularization)
  • Blood vessel events of the lower extremities (amputation of the lower extremities, revascularization of the lower extremities)
  • Incidence or exacerbation of retinopathy

Estimated Enrollment: 3000
Study Start Date: May 2006
Estimated Study Completion Date: December 2009
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   45 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

    1. Glucose level: Patients with hemoglobin A1c (HbA1c) of 7.0% or higher, who are on treatment with some of the following treatments:

      • Only diet therapy and exercise therapy
      • Treatment with 1 oral hypoglycemic agent
      • Treatment with 1 alpha-glucosidase inhibitor (alpha-GI) and one of the other oral hypoglycemic agents
    2. Blood pressure (BP): Patients meeting some of the following conditions of casual BP at the time of the ambulatory practice:

      • Systolic blood pressure (SBP) >= 140 mm Hg or diastolic blood pressure (DBP) >= 90 mm Hg without use of anti-hypertensive agent
      • SBP >= 130 mm Hg or DBP >= 80 mm Hg on treatment with 1 or 2 medications of angiotensin II receptor blockers, angiotensin converting enzyme inhibitors, or long-acting calcium (Ca) channel blockers.

      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.

    3. Lipid metabolism: Patients meeting some of the following 3 conditions of fasting levels without use of medication for the treatment of hyperlipemia:

      • Low-density lipoprotein cholesterol (LDL-C) (calculated by Friedewald's equation) >= 120 mg/dL
      • Triglycerides >= 150 mg/dL
      • High-density lipoprotein cholesterol (HDL-C) < 40 mg/dL.

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 BP that is poorly controlled in spite of drug therapy (SBP >= 200 mm Hg or DBP >= 120 mm Hg).
  • Patients on treatment with insulin.
  • Patients with nondiabetic renal diseases.
  • Patients who are strongly suspected of having type 1 DM (including slow progressive type 1) and those with suspected DM due to other specific mechanisms or diseases.
  • Patients who are confirmed to be positive for anti-GAD antibodies.
  • Patients with LDL-C >= 200 mg/dL.
  • Patients with suspected secondary hypertension other than renal hypertension.
  • Patients with high-risk family histories, who are suspected of having hereditary dyslipidemia.
  • Patients on treatment with anti-hypertensive drugs other than angiotensin II receptor blockers, angiotensin converting enzyme inhibitors, and long-acting Ca channel blockers. This rule, however, does not apply in the case in which these anti-hypertensive drugs are administered for other purposes.
  • Patients on treatment with at least 3 drugs including angiotensin II receptor blockers, angiotensin converting enzyme inhibitors, and long-acting Ca channel blockers. This rule, however, does not apply in the case in which these drugs are administered for purposes other than anti-hypertension.
  • Patients with proliferative retinopathy or more severe retinopathy.
  • Patients with renal failure [serum creatinine >= 2.0 mg/dL (males) and >= 1.5 mg/dL (females)].
  • Patients with a past history of cardiac failure or those complicated currently by cardiac failure.
  • Pregnant or possibly pregnant patients.
  • Patients with BNP >= 100 pg/mL, who meet some of the following conditions:

    • Myocardial infarction
    • Angina pectoris (or a past history of angina pectoris)
    • A past history of bypass operation on the coronary artery
    • A past history of percutaneous coronary revascularization
    • Other heart diseases
    • Electrocardiogram (ECG) findings of left ventricular hypertrophy (LVH)
  • Other patients who are determined to be eligible by investigators.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00300976

Contacts
Contact: Takashi Kadowaki, MD, PhD +81-3-5800-8815 kadowaki-3im@h.u-tokyo.ac.jp

Locations
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            
Sponsors and Collaborators
Japan Foundation for the Promotion of International Medical Research Cooperation
Investigators
Principal Investigator: Toshitsugu Oda The Japan Foundation for the Promotion of International Medical Research Cooperation
  More Information

No publications provided

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

Keywords provided by Japan Foundation for the Promotion of International Medical Research Cooperation:
Blood glucose
Blood pressure
Lipids

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009