Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes Sitagliptin Glimepiride Elderly patients Japanese
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 305
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the efficacy and the safety of sitagliptin and glimepiride in drug naïve elderly patients with Type 2 diabetes as evaluated by HbA1c change from baseline at 52 W as efficacy and incidence of hypoglycemia from randomization to 52 W as safety. The clinical hypotheses are non-inferiority of sitagliptin to glimepiride in efficacy as judged by HbA1c change from baseline at 52 W and superiority of sitagliptin to glimepiride in safety as judged by incidence of hypoglycemia in drug naïve elderly patients with T2DM. In addition, comparison of efficacy is extended to 104 W.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Sitagliptin intervention 2: Glimepiride
Intervention descriptions: intervention 1: Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; estimate glomerular filtration rate (eGFR) 30=\< \<50). intervention 2: Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg

Protocol document: