Twelve-week Monotherapy with the Dpp-4 Inhibitor Vildagliptin Improves Glycemic Control in Subjects with Type 2 Diabetes.
From: University of Vermont College of Medicine, Burlington, VT 05401, USA. richard.pratley@uvm.edu
Hormone and metabolic research. Hormon- und Stoffwechselforschung. Hormones et métabolisme
- Publish Date: Jun 2006
- ISSN: 0018-5043
- Volume: 38
- Issue: 6
- Pages: 423-8
- Medium: Print
- Language: English
- Citation (JAMA): Pratley R E, Jauffret-Kamel S, Galbreath E, et al. Twelve-week Monotherapy with the Dpp-4 Inhibitor Vildagliptin Improves Glycemic Control in Subjects with Type 2 Diabetes.. Horm. Metab. Res. Jun 2006;38:423-8
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 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 %). CONCLUSION: 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.
Mesh Headings (Keywords): Adamantane, Adenosine Deaminase, Adult, Aged, Antigens, CD26, Blood Glucose, Diabetes Mellitus, Type 2, Double-Blind Method, Female, Glycoproteins, Hemoglobin A, Glycosylated, Humans, Male, Middle Aged, Nitriles, Placebos, Protease Inhibitors, Pyrrolidines
Check for Full Text / PubMed Unique Identifier (PMID): 16823726
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