Type 2 diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with type 2 diabetes inadequately controlled with following therapies (HbA1c 6.9~10.4%) 1) diet and exercise therapy 2) treated with glinides or biguanides or pioglitazone monotherapy 3) treated with glinides and biguanides or pioglitazone (dual therapy)
Exclusion criteria
Exclusion criteria: 1) kidney dysfunction (serum creatinine > 1.5 mg/dl in men, >1.3 mg/dl in women, or nephrotic syndrome) 2) heart failure, stroke 3) liver dysfunction (serum AST and/or ALT >100mU/ml or liver cirrhosis) 4) respiratory failure (needing oxygen therapy) 5) pregnant women 6) treated with sulfonyureas or alpha-glucosidase inhibitors 7) ketosis, diabetic coma, type 1 diabetes mellitus, severe infection 8) dementia 9) other inadequate patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c, body weight, hypoglycemia | — |
Secondary
| Measure | Time frame |
|---|---|
| glycoalbumin, 1, 5-anhydroglucitol, blood pressure, lipids, insulin, proinsulin, adiponectin, leptin, CRP, bone metabolic markers, durability, safety | — |
Countries
Japan
Contacts
Jichi Medical University Division of Endocrinology and Metabolism