Type 2 diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) HbA1c levels of >=6.5% to <8.5%, as defined by the National Institutes of Diabetes and Digestive and Kidney Diseases (2) Age >=20years on the date of submission of informed consent (3) Under treatment with fixed diet and exercise therapy >=8weeks (4) When treated with oral antidiabetic drugs; under treatment with a fixed dose and regimen >=8 weeks (5) Submission of written informed consent for participation in this study
Exclusion criteria
Exclusion criteria: (1) Type-1 diabetes, diabetes due to a pancreatic disorder, or secondary diabetes due to conditions (2) Application of contraindications contained in the package insert (3) Severe renal function disorder (4 )BMI is < 22kg/m2 (5) Under treatment with insulin,GLP-1 analog,or SGLT-2 inhibitor (6) Pregnant women, women suspected of being pregnant, or lactating women (7) Participation in the study is judged by the investigator or sub-investigator as inappropriate for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Glycosylated hemoglobin (HbA1c) levels over 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in fasting blood glucose, body weight, waist circumference, IRI, serum lipid and body composition over 6 months. 2)CGM | — |
Countries
Japan
Contacts
Nakakinen clinic Clinical Laboratory