Type 2 diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Type 2 diabetes patients with inadequate glycemic control Sulfonylurea(Glimepiride:1 or 2mg once a day) monotherapy (HbA1c:6.9% or more, less than 10.5%)
Exclusion criteria
Exclusion criteria: Patients with type 1 diabetes Patients with a history of severe ketosis, diabetic coma or pre-coma within the past six months Patients with severe infection, before and after surgery, or severe trauma Patients with moderate renal impairment or more(serum creatinine level:1.5mg/dl or more(male),1.3mg/dl or more(female)) Patients in the insulin therapy, rapid insulin secretagogue, or alpha-glucosidase inhibitor Patients with a planned pregnancy or likely to be pregnant or lactating patients, or pregnant patients Patients with a history of hypersensitivity to study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c Change in weight Incidence of hypoglycemia | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in fasting insulin level Change in fasting blood glucose level Treatment compliance | — |
Countries
Japan
Contacts
Osaka Saiseikai Noe Hospital Department of diabetes and endocrinology