Type 2 diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria:
Exclusion criteria
Exclusion criteria: (1)Patients with type 1 diabetes (2)Patients with a history of severe ketosis, diabetic coma, or diabetic pre-coma within 6 months prior to the start of study (3)Patients with severe infection or serious trauma, or in a pre- or post-operative phase (4)Patients with a history of hypersensitivity to the components of the study drug (5)Patients with severe renal dysfunction (eGFR <30 mL/min/1.73 m2) or end-stage renal failure undergoing dialysis (6)Patients with serious hepatic dysfunction (7)Pregnant or lactating women, or those expecting to become pregnant during the study period (8)Patients judged inadequate to enroll in the study at the discretion of principal investigator or subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Blood glucose-related: HbA1c, fasting glucose, glucagon 2.Insulin secretion-related: fasting insulin, plasma glucose after glucose tolerance test, fasting blood CPR, CPI 3.Insulin resistance: Matsuda Index 4.Metabolic syndrome-related: Abdominal circumference, neutral fat, HDL cholesterol, blood pressure 5.Oxidative stress-related: high-sensitivity CRP, adiponectin | — |
Countries
Japan
Contacts
Bell Medical Solutions Inc. Clinical Research and Development