A Comparative Study of Insulin Secretagogue (SU Agent) and Insulin sensitizers (TZD)
- Conditions
- Type2 diabetes
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Not provided
At preliminary registration (1)Type 1 DM (2)The use of insulin preparations or oral hypoglycemic agents (including a-GI) within 4 weeks prior to the start of observation period. (3)Cardiac failure at present or in the past (4)Concurrent serious cardiac, renal, hepatic, pancreatic or blood disease. (5)Women who are pregnant, wishing to become pregnant, or lactating. (6)Excessive alcohol drinking. (7)Past history of drug allergies. (8)Those who are participating in other clinical studies (excluding epidemiological studies). (9)Those who are determined inappropriate for the study by the investigator. At formal registration (1)The use of insulin preparations or oral hypoglycemic agents (including a-GI) within 4 weeks prior to the start of observation period. (2)Cardiac failure at present or in the past (3)Concurrent serious cardiac, renal, hepatic, pancreatic or blood disease. (4)Women who are pregnant, wishing to become pregnant, or lactating. (5)Excessive alcohol drinking. (6)Past history of drug allergies. (7)Those who are participating in other clinical studies (excluding epidemiological studies). (8)Those who are determined inappropriate for the study by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate for achieving the HbA1c level of < 6.5% at Month 6
- Secondary Outcome Measures
Name Time Method Secondary endpoints in Step 1 1)Change in the HbA1c level at Month 6. 2)Changes in the FPG level, fasting insulin level, lipid metabolism, body weight, BMI, blood pressure and BNP at Month 6. Secondary endpoints in Step 2 1)The rate for achieving the HbA1c level of 6.5% in the total subjects in each randomized group in Step 1. 2)The rates for achieving the target HbA1c level in the monotherapy groups. 3)Change in the HbA1c level in the monotherapy groups. 4)Changes in the FPG level, fasting insulin level, lipid metabolism, body weight, BMI, blood pressure and BNP at Month 12.5. 5)Changes in the dose of the drug and the HbA1c level. 6)Medical economic evaluation (medical expenses, new expenses for treatment and tests/ examinations required at the onset of adverse reactions, drugs necessary for lowering the HbA1c level by 1%, and drugs and medical care necessary for improving the DTSQ score by 1 point).