Type 2 Diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with type 2 diabetes receiving either metformin and/or miglitol for at least two months before the start of the run-in period without any changes in the type or dosage of the drug 2.HbA1c(NGSP) is less than 8.0% more than 6.5% measured during the run-in period
Exclusion criteria
Exclusion criteria: 1.Patients require insulin or oral antidiabetic drug therapy other than metformin and/or miglitol 2.Female patients who were pregnant,suspected of being pregnant,planning a pregnancy,or lactating 3.Patients with,or a history of,serious renal disease(Serum Creatinine of >=2mg/dL 4.Any patients deemed by the investigator to be ineligible for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy:HbA1c,Glyco-albumin,Fasting blood glucose,Serum lipid(TG,TC,LDL-C,HDL-C),Meal load test(Post prandial glucose,active-GLP-1,active-GIP,Ghrelin,PYY,Leptin),Body weight,Body fat percentage,amount of fat Safety:AE,clinical laboratory test | — |
Countries
Japan
Contacts
Nakakinen Clinic Director