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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
305
Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; estimate glomerular filtration rate (eGFR) 30=\< \<50).
Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
Japan Association for Diabetes Education and Care
Chiyoda-Ku, Tokyo, Japan
Change From Baseline in HbA1c at 52 W
Time frame: Baseline and 52 W
Number of Participants With Hypoglycaemia
Time frame: From baseline to 52 W
The Number of Participants Achieving HbA1c < 6.9 %
Time frame: 52 W
Change From Baseline in HOMA-β at 52 W
β cell function is measured by the Homeostatic Model Assessment(HOMA-β). HOMA β = \[20 x fasting insulin (μU/mL)\] / \[fasting plasma glucose (mmol/L) - 3.5\]
Time frame: Baseline and 52 W
Change From Baseline in Insulin/Proinsulin Ratio at 52 W
Time frame: Baseline and 52 W
Change From Baseline in Body Weight at 52 W
Time frame: Baseline and 52 W
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