Efficacy and Tolerability of Sitagliptin Compared with Glimepiride in Elderly Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control: A Randomized, Double-Blind, Non-Inferiority Trial

The aim of this study was to evaluate the efficacy and tolerability of sitagliptin compared with glimepiride in elderly patients with type 2 diabetes mellitus (T2DM) and inadequate glycemic control with diet and exercise alone.

This was a randomized, parallel-group, multinational, non-inferiority clinical trial with an active-controlled, double-blind treatment period in which patients ≥65 and ≤85 years of age with T2DM were screened at 85 sites. Patients were randomized to once-daily sitagliptin (100 or 50 mg, depending on renal function) or glimepiride (in titrated doses) for 30 weeks. The main outcome measures were change from baseline in glycated hemoglobin (HbA_1c), fasting plasma glucose (FPG), and body weight; and the incidence of symptomatic hypoglycemia.

The mean baseline HbA_1c was 7.8 % in both the sitagliptin group (n = 197) and the glimepiride group (n = 191). After 30 weeks, the least squares (LS) mean change in HbA_1c baseline was −0.32 % with sitagliptin and −0.51 % with glimepiride, for a between-group difference (95 % CI) of 0.19 % (0.03–0.34). This result met the pre-specified criterion for declaring non-inferiority, which required that the upper 95 % confidence limit lie below 0.4 %. The LS mean change in FPG from baseline was −14.5 mg/dL with sitagliptin and −21.2 mg/dL with glimepiride, for a between-group difference (95 % CI) of 6.7 mg/dL (0.7–12.7). The percentages of patients with adverse events of symptomatic hypoglycemia were 0.8 % in the sitagliptin group and 4.7 % in the glimepiride group (between-treatment difference = −3.9 %, p = 0.009). The LS mean change in body weight from baseline was 0.4 kg with sitagliptin and 1.1 kg with glimepiride, for a between-group difference of −0.7 kg (p = 0.011).

In elderly patients with T2DM and inadequate glycemic control with diet and exercise alone, sitagliptin provided non-inferior glycemic control after 30 weeks of treatment compared with glimepiride. Compared with glimepiride, sitagliptin had a lower risk of hypoglycemia. Sitagliptin was weight-neutral; while the between-group difference in change from baseline in body weight was statistically significant, the modest difference may not be clinically meaningful.

ClinicalTrials.gov NCT01189890.