Efficacy and safety of sitagliptin/metformin fixed-dose combination compared with glimepiride in patients with type 2 diabetes: A multicenter randomized double-blind study

• Kim S.S.
• Kim In Joo
• Lee K.J.
• Park J.H.
• Kim Y.I.
• Lee Y.S.
• Chung S.C.
• Lee S.J.

Abstract

EarLy initiation of combination therapy using antihypergLycemic agents is recommended for treating type 2 diabetes (T2D). The present muLticenter doubLe-bLind randomized paraLLeL-group study examined the efficacy and safety of a sitagLiptin and metformin fixed-dose combination (Sita/Met) compared with gLimepiride in T2D patients as initiaL treatment.

Methods. Type 2 diabetes patients (aged ≥18 years) were randomized to Sita/Met or gLimepiride for 30 weeks after a wash-off run-in period. The primary endpoint was change from baseLine (CFB) in HbA_1c. Sec­ondary endpoints incLuded the proportion of patients achieving target goaL [HbA_1c<7.0% (53 mmoL/moL)] and CFB in fasting pLasma gLucose (FPG). Safety assessments comprised weight gain from baseLine and the incidence of adverse events (AEs).

Results. In totaL, 292 patients were randomized to Sita/Met (n=147) or gLimepiride (n=145). After 30 weeks, Sita/Met demonstrated superiority over gLimepiride in reducing HbA_1c (1.49% vs 0.71%, respectiveLy; between-group difference 0.78%; р<0.001). A significantLy higher proportion of patients achieved the target goaL with Sita/Met (81.2%) than with gLimepiride (40.1%; р<0.001). Greater reduction in FPG occurred with Sita/Met than with gLimepiride (Least-squares mean difference 23.5 mg/dL; р<0.001). Both drugs were generaLLy weLL toLerated. HypogLycemia events and weight gain were significantLy Lower in patients with Sita/Met than with gLimepiride (5.5% vs 20.1% and 0.83 vs + 0.90 kg, respectiveLy; both р<0.001). No serious drug-reLated AEs or deaths were reported.

Conclusions. Compared with glimepiride, Sita/Met as an initial treatment led to significantly greater improvements in glycemic control and body weight changes, with a lower incidence of hypoglycemia, over 30 weeks.

Keywords:glimepiride, hypoglycemia, metformin, sitagliptin phosphate

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