Type2 diabetes
Conditions
Interventions
[Step 1] The assigned study drug will be administered alone. Insulin secretagogue (SU agent) Treatment with the insulin secretagogue should be started at a half of the usual dose when the HbA1c lev
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6.5% to <
7.0%, and at the usual dose when the HbA1c level is &
7.0% to <
10.0%. Thereafter, the dose should be adjusted as necessary for achieving the morning FPG level of <
120 mg/dL. [Step 2] Combination therapy will be started or monotherapy will be continued according to the directions in Table 1 taking account of an evaluation of the HbA1c level at Month 6 and the
120 mg/dL. If the subjects do not achieve the HbA1c <
6.5% after reaching the maximum dose during the treatment period, coadministration with the insulin sensitizer (TZD) should be started as in Item (2). (2)When the insulin secretagogue (SU agent) is c
120 mg/dL.
[Step 1] The assigned study drug will be administered alone. Insulin sensitizer (TZD) The doses of pioglitazone should be as follows: 15 mg/day as the starting dose, 30 mg/day as the
120 mg/dL. [Step 2] Combination therap
Sponsors
Japan Association for Diabetes Education and Care
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At preliminary registration (1)Being treated only with dietary management and/or therapeutic exercise. (2)HbA1c >= 6.5% to < 10.0% at preliminary registration. (3)Age at treatment initiation: 30 to 73 years* (4)Sex: Male and female (5)Inpatient or outpatient (6)Being capable of providing informed consent to participate in the study, reading the informed consent document and understanding its contents. At formal registration (1)Being treated only with diet and exercise. (2)HbA1c >= 6.5% to < 10.0% at formal registration (3)A < 1.0% difference in HbA1c from the level at preliminary registration.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate for achieving the HbA1c level of < 6.5% at Month 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Japan
Contacts
Public ContactNobuyuki Shihara
Japan Association for Diabetes Education and Care secretariat
Outcome results
None listed