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Sponsored by: |
Japan Early Diabetes Intervention Study Group |
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Information provided by: | Japan Early Diabetes Intervention Study Group |
ClinicalTrials.gov Identifier: | NCT00464594 |
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).
Condition | Intervention |
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Diabetes Mellitus |
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 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Comparative Clinical Study on Suppression of Progression From Early Diabetes, Diet/Exercise Standard Intervention vs. Concurrent Pharmacological Standard Intervention |
Estimated Enrollment: | 2560 |
Study Start Date: | April 2007 |
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.
Ages Eligible for Study: | 30 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kazuo Ichikawa | 81-3-3814-8010 | info@jedis2560.org |
Japan | |
Tokyo Medical and Dental University | Recruiting |
Tokyo, Japan, 113-8519 | |
Contact 03-3813-6111 |
Principal Investigator: | Takeshi Kuzuya | Jichi Medical University |
Study ID Numbers: | JEDIS ver.4.0, UMIN000000681 |
Study First Received: | April 19, 2007 |
Last Updated: | April 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00464594 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Japan Early Diabetes Intervention Study |
Acarbose Metabolic Diseases Gliclazide Metformin Disease Progression |
Diabetes Mellitus Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |