Type 2 diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Type 2 diabetes mellitus patients. As for the study of diabetes control, patients with HbA1c higher than or equal to 6.5 % and lower than 10 %. As for the study of renal impairment, patients with eGFR<60mL/min/1.73m2, urine albumin >= 30mg/gCr, or urine protein >= 0.15g/gCr. As for the study of cognitive function, patients 70 years of age and older. Patients not planned to be treated with prohibited combined drugs
Exclusion criteria
Exclusion criteria: Type 1 diabetic patients. Patients with a history of severe ketosis or diabetic coma in previous 6 months. Patients with severe infection, before/after surgery or severe traumatic injury. Patients to have a plan to be pregnant. Patients with severe gastroenteric disturbance as exemplified by severe gastro-paresis. Patients with a history of pancreatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of HbA1c,body weight at the 52th and the 104th week. As for patients with renal disturbance, change of serum creatinine, urine albumin(mg/gCr), urine protein (g/gCr) at the 52th and the 104th week. As for patients over 70 years old, change of MMSE at the 52th and the 104th week. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of data shown below at the 52th and the 104th week. AST, ALT, gamma-GTP, LDL-C, HDL-C,TG, non-HOL-C, serum creatinine, serum UA, eGFR, 1,5-AG, self-monitoring blood glucose, Urine albumin(mg/gCr),Urine protein (g/gCr) | — |
Countries
Japan
Contacts
Haga Diabetes Clinic Internal Medicine