Efficacy and Safety of Vildagliptin as an Add-On Therapy in Inadequately Controlled Type 2 Diabetes Patients Treated With Basal Insulin.
BACKGROUND
The aim of this study was to investigate the efficacy and safety of vildagliptin as an add-on therapy for patients with type 2 diabetes mellitus inadequately controlled with basal insulin.


METHODS
Twenty-four patients treated with basal insulin and oral anti-diabetes drugs were randomly allocated into two groups: the control group (did not receive any add-on drugs) and vildagliptin group (received vildagliptin 100 mg/day for 6 months). The primary outcome was changes in hemoglobin A1c (HbA1c) from baseline to end of study.


RESULTS
Treatment with vildagliptin significantly reduced HbA1c from 8.1±0.7% at baseline to 7.1±0.7% (P < 0.01), while there was no significant change of HbA1c in the control group. Vildagliptin group showed significant reduction of HbA1c compared with control group (-1.0±0.3% vs. 0.2±0.8%, P < 0.01). In addition, vildagliptin group showed a significant increase in 1,5-anhydroglucitol compared with the control group (4.5 ± 3.4 vs. 0.5 ± 4.1 μg/mL, P < 0.05). Mild hypoglycemia was reported in one patient of the vildagliptin group and two patients of the control group.


CONCLUSIONS
Vildagliptin improved glycemic control without increasing hypoglycemia in Japanese type 2 diabetes inadequately controlled with basal insulin treatment and other oral anti-diabetes drugs. This study was registered with UMIN (University Hospital Medical Information Network ID#000010849).
Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Daisuke
D
Saito
Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan; Center for Therapeutic Innovations in Diabetes, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Akio
A
Kanazawa
Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Nayumi
N
Shigihara
Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Fumihiko
F
Sato
Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Toyoyoshi
T
Uchida
Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Junko
J
Sato
Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Hiromasa
H
Goto
Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Takeshi
T
Miyatsuka
Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Fuki
F
Ikeda
Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Takeshi
T
Ogihara
Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Chie
C
Ohmura
Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan; Center for Therapeutic Innovations in Diabetes, Juntendo University Graduate School of Medicine, Tokyo, Japan; Center for Identification of Diabetic Therapeutic Targets, Juntendo University Graduate School of Medicine, Tokyo, Japan; Sportology Center, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Hirotaka
H
Watada
1,5-anhydroglucitol; Basal insulin; DPP-4 inhibitor