A Randomized Comparative Clinical Study on Suppression of Progression from Early Diabetes, Diet/exercise Standard Intervention vs. Concurrent Pharmacological Standard Intervention

UMIN ID: UMIN000000681

Registered date:18/04/2007

Basic Information

• Health condition(s) or Problem(s) studied: Newly-diagnosed early diabetes
• Date of first enrollment: 2007/04/01
• Target sample size: 2560
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Standard lifestyle guidance
Standard lifestyle guidance and pharmacological intervention (monotherapy with acarbose)
Standard lifestyle guidance and pharmacological intervention (monotherapy with metformin)
Standard lifestyle guidance and pharmacological intervention (monotherapy with gliclazide)

Outcome(s)

• Primary Outcome: - Progression/worsening to definite diabetes mellitus: Subjects are judged to have progressed to definite diabetes when FPG >= 140mg/dl and HbA1c >= 7.0% are confirmed more than one occasion by central Progression and Safety Assessment committee.
• Secondary Outcome: - Progression to warning glycemic level: Progression to a glycemic level warning means that more aggressive intervention should be done, for subjects with FPG >= 126 and HbA1c >= 6.5% - Appearance of diabetic microangiopathy (retinopathy or nephropathy) - Appearance of macroangiopathy

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 69years-old
• Gender: Male and Female
• Exclude criteria: a. Type 1 diabetes mellitus b. Undergoing treatment with steroids c. Secondary diabetes mellitus d. Diabetes mellitus due to suspected mitochondrial gene abnormalities or other gene abnormalities e. Very obese (BMI >= 35 kg/m2) or underweight (BMI < 18.5 kg/m2) f. Undergone a gastrectomy or abdominal surgery g. Severe hyperuricemia (gout) associated with organ dysfunction caused by hyperuricemia h. Severe vascular diseases with organ dysfunction i. Cancer or other malignant neoplasms j. Liver cirrhosis or chronic hepatic, chronic renal failure k. Gastrointestinal disorders such as diarrhea and vomiting l. Always performing rigorous muscular exercise m. Severe infection or serious trauma or, who are scheduled to undergo or who have just undergone surgery n. Women who are pregnant or with a possibility of pregnancy o. Alcohol dependence or drug dependence p. Drug allergy q. Anemic (males: Hb < 13 g/dL; females: Hb < 11 /dL) r. Abnormal hemoglobinuria. s. Severe mental disease undergoing treatment, Other individuals whom the investigator deems unsuitable for inclusion in this study (e.g., individuals who are very likely to be transferred to another locality during the course of the study)

Related Information

• Primary Sponsor: Japan Early Diabetes Intervention Study (JEDIS) Group
• Source(s) of Monetary Support: Japan Diabetes Foundation