title: Comparative analysis of the effects of alogliptin and vildagliptin on glucose metabolism in type 2 diabetes mellitus.
abstract: The aim of this 24-week, prospective randomized open-label study was to compare the effects of alogliptin and vildagliptin on glucose control, renal function, and lipid metabolism. In Study 1, DPP-4 inhibitor-naive type 2 diabetes (T2DM) were randomly assigned to alogliptin 25 mg/day or vildagliptin 50 mg twice daily. In Study 2, T2DM on treatment with 50 mg/day sitagliptin were switched to either 25 mg/day alogliptin or 50 mg twice daily vildagliptin. The primary endpoint was change in glycosylated hemoglobin (HbA1c) level at 24 weeks, while the secondary endpoints were changes in urinary albumin excretion and low-density lipoprotein cholesterol (LDL-C) levels at 24 weeks. In Study 1, HbA1c levels changed at 24-week by -0.5±0.7% in the alogliptin group (p=0.002, relative to baseline) and -0.7±0.9% in the vildagliptin group (p=0.001, relative to baseline), and the extent of these changes were comparable between the two groups (p=0.219). The decrease in log urinary albumin excretion was more significant in the vildagliptin group (p=0.008). In Study 2, HbA1c levels at 24-week changed by 0.2±0.7% in the switch-to-alogliptin group (p=0.007) and 0.0±0.6% in the switch-to-vildagliptin group (p=0.188), indicating a significant difference between the groups (p=0.003). In both studies, the changes in LDL-C levels were comparable between the two groups. The two drugs had comparable glucose-lowering effects in DPP-4 inhibitor-naive patients but the effect was more pronounced for vildagliptin in patients switched from sitagliptin. The results may point to subtle yet important differences between the two DPP-4 inhibitors. This trial was registered with UMIN (no. #000019022).
authors.affiliation: First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu 807-8555, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Tanaka
authors.forename: Yosuke
authors.initials: Y
authors.lastname: Okada
authors.forename: Hiroko
authors.initials: H
authors.lastname: Mori
authors.forename: Megumi
authors.initials: M
authors.lastname: Miyazaki
authors.forename: Fumi
authors.initials: F
authors.lastname: Kuno
authors.forename: Satomi
authors.initials: S
authors.lastname: Sonoda
authors.forename: Kei
authors.initials: K
authors.lastname: Sugai
authors.forename: Maiko
authors.initials: M
authors.lastname: Hajime
authors.forename: Akira
authors.initials: A
authors.lastname: Kurozumi
authors.forename: Manabu
authors.initials: M
authors.lastname: Narisawa
authors.forename: Keiichi
authors.initials: K
authors.lastname: Torimoto
authors.forename: Tadashi
authors.initials: T
authors.lastname: Arao
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Mine
authors.forename: Yoshiya
authors.initials: Y
authors.lastname: Tanaka
mesh_terms: D000218:Adamantane / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D000368:Aged; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000378:metabolism; D005260:Female; D005947:Glucose / Q000378:metabolism; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000494:pharmacology* / Q000627:therapeutic use; D010880:Piperidines / Q000494:pharmacology* / Q000627:therapeutic use; D011759:Pyrrolidines / Q000494:pharmacology* / Q000627:therapeutic use; D016896:Treatment Outcome; D014498:Uracil / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D000077597:Vildagliptin
chemical_list: D000218:Adamantane; D001786:Blood Glucose; D005947:Glucose; D006442:Glycated Hemoglobin; D009570:Nitriles; D010880:Piperidines; D011759:Pyrrolidines; D014498:Uracil; D000077597:Vildagliptin; C517652:hemoglobin A1c protein, human; C520853:alogliptin