type 2 diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Japanese patients with hemoglobin A1c (JDS) level 6.5% and higher under antidiabetic treatment with lifestyle modification and/or oral hypoglycemic agents (sulfonylureas, biguanides, thiazolidinediones, and/or alpha-glucosidase inhibitors)
Exclusion criteria
Exclusion criteria: 1) type 1 diabetes mellitus 2) history of severe ketosis, diabetic coma, or pre-coma within six months 3) severe infection, pre- or post-surgery, or severe trauma 4) renal dysfunction with serum creatinine >= 1.5 mg/dl in males or 1.3 mg/dl in females 5) body mass index >= 40 kg/m2 6) women who are pregnant, breast-feeding, or suspected of being pregnant 7) history of hypersensitivity to the investigational medication 8) patients whose participation in the current trial is evaluated as being inadequate by the doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the change of glucose metabolism and insulin secretion evaluated with the use of stable isotope tracers and hyperglycemic clamp technique | — |
Countries
Japan