Type 2 diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: "1) Type 2 diabetes mellitus patients on diet and exercise therapy with inadequate blood glucose control 2) More than 20 years of age at the time of informed consent acquisition 3) Both females and males 4) Patients whose HbA1c (NGSP values) is more than 6.5% 5) Patients who received explanation of the study by using an informed consent form and gave written consent on study participation "
Exclusion criteria
Exclusion criteria: "1) Patients with type 1 diabetes mellitus 2) Patients who had severe ketosis, diabetic coma, or precoma within 6 months 3) Patients with severe infection, perioperative patients, patients with severe trauma 4) Patients hypersensitive to ingredients of the drug used or its excipient 5) Patients with severe renal dysfunction (eGFR < 30 ml/min/1.73 m2) or terminal renal failure patients undergoing dialysis 6) Patients with severe hepatic dysfunction 7) Patients who are pregnant or breast-feeding 8) Patients considered inappropriate to participate in the study by the principal (sub-) investigator "
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood glucose (fasting), IRI, CPR, Glucagon, Leptin, diponectin, TG, TC, LDL-C, HDL-C, ALT (GPT), AST (GOT), GGT, Uric acid, Creatinine, L-FABP, Urine microalbumin, Blood pressure, Body weight, Questionnaire (patient satisfaction, etc.) | — |
Countries
Japan
Contacts
Miura Central Clinic internal medicine