The Japan Diabetes Optimal Integrated Treatment Study for 3 Major Risk Factors of Cardiovascular Diseases

Exclusion Criteria

• •1\. Those with poorly controlled hypertension despite pharmacological therapy (systolic BP 200 mmHg or diastolic BP 120 mmHg) 2. Those on insulin therapy 3. Those with non-diabetic renal disease 4. Those in whom type 1 and other diabetes due to pathogenic mechanisms other than those associated with type 2 diabetes is strongly suspected 5. Those who tested anti-GAD antibody\*-positive 6. Those with LDL-cholesterol 200 mg/dL 7. Those suspected of having secondary hypertension other than renal parenchymal hypertension 8. Those suspected of having hereditary lipid disorder with a strong family history of lipid metabolic disorder 9. 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 10. 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 11. Those with more serious retinopathy than proliferative retinopathy 12. Renal failure (serum Cr: 2.0 mg/dL in men; 1.5 mg/dL in women) 13. Those with a history of cardiac failure or those with cardiac failure 14. Those who were pregnant or potentially pregnant 15. Those who met any of the following criteria and who had BNP 100 pg/mL, Myocardial infarction, Angina pectoris (or a history of disease), History of coronary artery bypass graft (CABG), History of percutaneous coronary angioplasty (PTCA), Other cardiac disease, ECG findings of left ventricular hyperplasia, Abnormal ECG findings (excluding isolated extrasystole or right bundle branch block \[RBBB\]) 16. Those judged by the physician in charge to be ineligible for study entry
• •(Follow-up study)
• •A subject who is assessed as ineligible by the investigator will be excluded from the follow-up study