Official Title: “A Randomized Comparative Clinical Study on Suppression of Progression From Early Diabetes, Diet/Exercise Standard Intervention vs. Concurrent Pharmacological Standard Intervention”

The purpose of this study is to compare the suppressive effect of two kinds of interventions on the worsening/progression to definite diabetes: standard lifestyle guidance and standard lifestyle guidance combined with pharmacological intervention (monotherapy with one of acarbose, metformin, or gliclazide).

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

In newly-diagnosed early diabetes patients, a randomized comparative study will be conducted to compare the suppressive effect of the following two kinds of interventions on the worsening/progression to definite diabetes which has a harmful hyperglycemia i.e. an increased risk of microangiopathy: standard education for the improvement of lifestyle in accordance with the “Guidelines for the Treatment of Diabetes Mellitus in Japan” of the Japan Diabetes Society (JDS) and standard lifestyle guidance combined with pharmacological intervention using the lowest possible dose of commercially available oral hypoglycemic agents (one of acarbose, metformin, or gliclazide) in Japan.

Intervention(s) in this Clinical Trial

• Behavioral: Standard lifestyle guidance
• Drug: Lifestyle guidance and monotherapy with acarbose
• Drug: Lifestyle guidance and monotherapy with metformin
• Drug: Lifestyle guidance and monotherapy with gliclazide

Primary Measures

• FPG >= 140mg/dl and HbA1c >= 7.0%

Inclusion Criteria:

• Results of 75-g oral glucose tolerance test (75 g OGTT)will be used to confirm FPG <= 125 mg/dL, 2-h PG >= 200 mg/dL and HbA1c <= 6.9%

Exclusion Criteria:

• Type 1 diabetes mellitus
• Undergoing treatment with steroids
• Secondary diabetes mellitus
• Diabetes mellitus due to suspected gene abnormalities
• BMI >= 35 kg/m2 or BMI < 18.5 kg/m2
• Undergone a surgery
• Severe hyperuricemia (gout) associated with organ dysfunction
• Severe vascular diseases with organ dysfunction
• Cancer or other malignant neoplasms
• Liver cirrhosis or chronic hepatic, chronic renal failure
• Gastrointestinal disorders
• Always performing rigorous muscular exercise
• Severe infection or serious trauma
• Women who are pregnant
• Alcohol dependence or drug dependence
• Drug allergy
• Anemic
• Abnormal hemoglobinuria
• Severe mental disease

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 69 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Japan Early Diabetes Intervention Study Group

Overall Clinical Trial Officials and Contacts

Takeshi Kuzuya Principal Investigator Jichi Medical University  

Overall Contact: Kazuo Ichikawa 81-3-3814-8010 info@jedis2560.org

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00464594

Study ID Number: JEDIS ver.4.0

ClinicalTrials.gov Identifier: NCT00464594

Health Authority: Japan: Ministry of Health, Labor and Welfare