Twelve-week monotherapy with the DPP-4 inhibitor vildagliptin improves glycemic control in subjects with type 2 diabetes.
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 HbA1c 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 HbA1c 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 %).


CONCLUSIONS
monotherapy with vildagliptin is well tolerated and improves glycemic control in diet-treated subjects with type 2 diabetes. Concomitant improvements in beta-cell function were also observed. Subjects with higher baseline HbA1c levels showed greater response.
Pratley
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RE
University of Vermont College of Medicine, Burlington, VT 05401, USA. richard.pratley@uvm.edu
Jauffret-Kamel
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Galbreath
E
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Holmes
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D
D000218:Adamantane / Q000031:analogs & derivatives* / Q000627:therapeutic use; D058892:Adenosine Deaminase Inhibitors; D000328:Adult; D000368:Aged; D001786:Blood Glucose; D003924:Diabetes Mellitus, Type 2 / Q000178:diet therapy / Q000188:drug therapy*; D018819:Dipeptidyl Peptidase 4; D004311:Double-Blind Method; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006023:Glycoproteins / Q000037:antagonists & inhibitors*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009570:Nitriles; D010919:Placebos; D011480:Protease Inhibitors / Q000627:therapeutic use*; D011759:Pyrrolidines; D000077597:Vildagliptin
D000218:Adamantane; D058892:Adenosine Deaminase Inhibitors; D001786:Blood Glucose; D018819:Dipeptidyl Peptidase 4; D006442:Glycated Hemoglobin; D006023:Glycoproteins; D009570:Nitriles; D010919:Placebos; D011480:Protease Inhibitors; D011759:Pyrrolidines; D000077597:Vildagliptin; C042807:DPP4 protein, human