Efficacy and Safety of Vildagliptin Monotherapy during 2-Year Treatment of Drug-naïve Patients with Type 2 Diabetes: Comparison with Metformin

Abstract

The present study was a 52-week extension of a previously published, multi-center, randomized, parallel-group study. The aim of this extension study was to compare the efficacy and tolerability of vildagliptin and metformin in drug-naïve patients with type 2 diabetes over 104 weeks. The extension population comprised 305 patients randomized to vildagliptin (100 mg daily) and 158 patients randomized to metformin (2 000 mg daily). Pioglitazone was added as rescue medication if fasting glucose was >10 mmol/l; data from patients receiving rescue medication were excluded from the primary analysis. Baseline HbA (1c) averaged 8.4+/-0.1% in patients randomized to vildagliptin and 8.8+/-0.1% in those randomized to metformin. The adjusted mean change from baseline to study endpoint was -1.0+/-0.1% in vildagliptin-treated patients and -1.5+/-0.1% in those receiving metformin (p<0.001 vs. vildagliptin). These results were similar to those reported after the 1-year core phase of the study. The adjusted mean changes in body weight from baseline to endpoint were 0.5+/-0.4 kg and -2.5+/-0.5 kg in the vildagliptin and metformin groups, respectively. One or more adverse event (AE) was reported by 82.2% of patients receiving vildagliptin and by 87.3% of those receiving metformin (p<0.001). Gastrointestinal AEs were more common in patients receiving metformin (45.6%) than in those receiving vildagliptin (25.0%, p<0.001 vs. metformin). One hypoglycemic event occurred after strenuous exercise in a single patient receiving vildagliptin (0.3%). In conclusion, both vildagliptin and metformin monotherapy provided clinically meaningful decreases in HbA (1c) over 2 years in drug-naïve patients with type 2 diabetes. Vildagliptin was weight neutral, while weight loss was observed with metformin; however, metformin was associated with significantly worse gastrointestinal tolerability.

A comparative study of efficacy and safety of vildagliptin against metformin in newly diagnosed patients of type 2 diabetes mellitus

“…The difference in the mean reductions of HbA1c in vildagliptin group and metformin group was not statistically significant (p>0.05). The mean reduction in vildagliptin group was comparable to that observed in studies conducted by Schweizer et al, Goke et al, and Schweizer et al 24,26 Schweizer et al and Goke et al reported a reduction in HbA1c of 1% with vildagliptin at the end of 52 week study and 104 weeks study, respectively. 23,24 Schweizer et al reported a reduction of 0.64% in HbA1c with vildagliptin at the end of 24 weeks in drug naïve elderly population.…”

“…The mean reduction in vildagliptin group was comparable to that observed in studies conducted by Schweizer et al, Goke et al, and Schweizer et al 24,26 Schweizer et al and Goke et al reported a reduction in HbA1c of 1% with vildagliptin at the end of 52 week study and 104 weeks study, respectively. 23,24 Schweizer et al reported a reduction of 0.64% in HbA1c with vildagliptin at the end of 24 weeks in drug naïve elderly population. 26 The mean reduction of HbA1c observed in metformin group (1.12%) was comparable to those reported by Schweizer et al, Goke et al and Schweizer et al 23,24,26 Schweizer et al and Goke et al reported a reduction of 1.4% and 1.5% respectively, with metformin.…”

“…Similar doses of metformin were used in studies conducted by Schweizer et al, Goke et al, Bosi et al, Schweizer et al conducted a study comparing 100 mg of vildagliptin daily versus 1500 mg of metformin daily, in drug naïve elderly patient of T2DM mellitus. 23,24,26,28 The mean reductions of FPG in vildagliptin and metformin groups were 37.84 mg/dL and 39.33 mg/dL respectively ( Table 3).…”

“…Patients in vildagliptin group were administered vildagliptin 50 mg twice daily (100 mg daily) orally. Similar doses of vildagliptin were used in many studies such as those conducted by Schweizer et al, Goke et al, Iwamoto et al, Schweizer et al and Pan et al [23][24][25][26][27] Patients in metformin group were administered metformin tablet 1000 mg twice daily (2000 mg daily) orally. Similar doses of metformin were used in studies conducted by Schweizer et al, Goke et al, Bosi et al, Schweizer et al conducted a study comparing 100 mg of vildagliptin daily versus 1500 mg of metformin daily, in drug naïve elderly patient of T2DM mellitus.…”

DPP-4 inhibitors in the management of type 2 diabetes: A critical review of head-to-head trials

“…As metformin is considered the first-line drug therapy for the management of T2DM [10,11], it is of interest to compare the efficacy (and safety) of aDPP-4 inhibitor with that of metformin in drug-naive T2DM patients insufficiently controlled with diet and exercise [12][13][14][15][16][17][18][19][20][21]. Overall, metformin (1000-2000 mg/day) demonstrated slightly (but significantly) greater reductions in both HbA 1c and body weight ( Table 1, Fig.…”