Twelve-week Monotherapy with the DPP-4 Inhibitor Vildagliptin Improves Glycemic Control in Subjects with Type 2 Diabetes

Abstract

Inhibition of dipeptidyl peptidase-4 enhances the activity of incretin hormones, improving glycemic control in subjects with type 2 diabetes. This twelve-week randomized, double-masked, placebo-controlled study assessed the efficacy and tolerability of the specific and potent oral dipeptidyl peptidase-4 inhibitor, vildagliptin (25 mg, bid, n = 70) vs. placebo (bid, n = 28) in previously diet-treated subjects with type 2 diabetes. Standardized meal tests were performed at baseline and endpoint. The between-group difference in adjusted mean change in HbA_1c from baseline to endpoint was - 0.6 ± 0.2 % (p = 0.0012) for the whole cohort (baseline 8.0 %) and - 1.2 % for subjects with baseline HbA_1c 8.0 - 9.5 %. Fasting glucose and mean prandial glucose were reduced by 1.1 ± 0.4 (p = 0.0043) and 1.9 ± 0.5 mmol/l (p < 0.0001), respectively. The between-group differences in corrected insulin response at peak glucose and mean prandial C-peptide were + 0.06 ± 0.02 (p = 0.0258) and + 0.10 ± 0.03 nmol/l (p = 0.0031), respectively. Vildagliptin had no effect on fasting lipid levels or body weight. The incidence of adverse events was similar in subjects receiving placebo (71.4 %) and vildagliptin (55.7 %). Conclusion: monotherapy with vildagliptin is well tolerated and improves glycemic control in diet-treated subjects with type 2 diabetes. Concomitant improvements in β-cell function were also observed. Subjects with higher baseline HbA_1c levels showed greater response.

Key words

Dipeptidyl peptidase IV - efficacy - glycemic control - incretin

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