Type 2 diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetic patients 2. HbA1c higher than 6.5% and lower than 11.0% 3. BMI higher than 18 and lower than 40 kg/m2 4. Patients who have been treated diet and exercise therapy alone, or patients who have never received drug therapy at baseline. 5. Patients who are able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have history or current serious diabetic complication. 2. Patients that insulin dependence is suspected. 3. Patients who have history or current cardiac failure (New York Heart Association Class III or IV), myocardial infarction or cerebrovascular disorder. 4. Patients whose eGFR lower than 45 mL/min/1.73m2, serum creatinine higher than 1.5 mg/dL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in fasting and postprandial blood glucose at week 12 by meal tolerance test | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c, body weight, fasting and postprandial serum insulin, proinsulin/insulin ratio, serum adiponectin at week 12 | — |
Countries
Japan
Contacts
Ogawa Red Cross Hospital Department of Internal Medicine