Sitagliptin added to voglibose monotherapy improves glycemic control in patients with type 2 diabetes

Abstract

Aims/introduction: Type 2 diabetes mellitus is a progressive disease that frequently requires patients to use more than one oral antihyperglycemic agent to achieve adequate glycemic control. The present multicenter, randomized study assessed the efficacy and safety of the addition of sitagliptin to ongoing voglibose monotherapy (0.2-0.3 mg three times daily) in Japanese patients with type 2 diabetes mellitus who had inadequate glycemic control (glycated hemoglobin ≥6.9% and <10.5%).

Materials and methods: The present study had an initial 12-week, double-blind treatment period in which patients were randomized (1:1) to sitagliptin 50 mg/day (n = 70) or placebo (n = 63), followed by a 40-week, open-label treatment period during which all patients received sitagliptin 50 mg/day, that could have been increased to 100 mg/day for patients meeting predefined glycemic criteria.

Results: After 12 weeks, treatment with sitagliptin resulted in placebo-subtracted mean changes from baseline in glycated hemoglobin (the primary end-point), fasting plasma glucose and 2-h postmeal glucose of -0.9%, -22.5 mg/dL and -51.3 mg/dL, respectively (all, P < 0.001). During the double-blind period, adverse experiences were reported with similar frequency in both treatment groups, and the occurrences of hypoglycemia and gastrointestinal adverse experiences were low. In the open-label period, sustained improvements in glycemic parameters were observed with sitagliptin treatment, and sitagliptin was generally well tolerated.

Conclusions: Sitagliptin added on to ongoing voglibose monotherapy provided significant improvements in glycemic parameters and was well tolerated in Japanese patients with type 2 diabetes mellitus who had inadequate glycemic control. This trial was registered with ClinicalTrials.gov (no. NCT00837577).

Keywords: Incretins; Sitagliptin; Voglibose.

Figures

Figure 1

Patient disposition. Patients who received placebo during the double‐blind period and open‐label sitagliptin in the open‐label period (P/S group). Patients who received sitagliptin in both periods (S/S group).

Figure 2

Time course of glycated hemoglobin (HbA1c) in Japanese patients with type 2 diabetes mellitus treated with double‐blind sitagliptin 50 mg/day or the placebo added to voglibose for the first 12 weeks and open‐label sitagliptin 50 or 100 mg/d added to voglibose for the subsequent 40 weeks. The data are values for mean ± standard error (SE), and results from the patients who received the placebo during the double‐blind period and open‐label sitagliptin in the open‐label period (P/S group) and patients who received sitagliptin in both periods (S/S group) treatment groups are shown with open and closed circles, respectively. Statistics for HbA1c were calculated using at each time‐point the data available for that specific time‐point. The sample sizes at each time‐point are shown beneath the plots.