Trial | NCT00464594  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    gliclazide acarbose sitagliptin ...

  • Study Participants

    2560
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).
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.
Study Started
Apr 30
2007
Last Update
Apr 24
2007
Estimate

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

Criteria 

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
No Results Posted