TY - JOUR
T1 - Sitagliptin monotherapy has better effect on insulinogenic index than glimepiride monotherapy in Japanese patients with type 2 diabetes mellitus
T2 - A 52-week, multicenter, parallel-group randomized controlled trial
AU - Kondo, Yaeko
AU - Harada, Norio
AU - Hamasaki, Akihiro
AU - Kaneko, Shizuka
AU - Yasuda, Koichiro
AU - Ogawa, Eiichi
AU - Harashima, Shin Ichi
AU - Yoneda, Hiroko
AU - Fujita, Yoshihito
AU - Kitano, Norikazu
AU - Nakamura, Yoshio
AU - Matsuo, Fujio
AU - Shinji, Megumi
AU - Hinotsu, Shiro
AU - Nakayama, Takeo
AU - Inagaki, Nobuya
N1 - Funding Information:
Nobuya Inagaki served as a medical advisor for Takeda, Taisho Pharmaceuti‑ cal, GlaxoSmithKline, Mitsubishi Tanabe Pharma, lectured for Merck Sharp & Dohme (MSD), Sanofi, Novartis Pharma, Dainippon Sumitomo Pharma, Kyowa Kirin, and Mitsubishi Tanabe Pharma, and received payment for his services. Nobuya Inagaki also received a clinical commissioned/joint research grant from MSD, Eli Lilly Japan, Shiratori Pharmaceutical, Roche Diagnostics, and the Japan Diabetes Foundation, and also received a scholarship grant from MSD, JT, Nippon Boehringer Ingelheim, Takeda, Dainippon Sumitomo Pharma, Astellas Pharma, Daiichi‑Sankyo, and Mitsubishi Tanabe Pharma. Kazuaki Nagashima received funding from MSD. Shizuka Kaneko received funding from Novartis Pharma and Novo Nordisk. Takashi Matsuoka received funding from Eli Lilly Japan and Novartis Pharma. Shimpei Fujimoto received funding from Takeda, Mitsubishi Tanabe Pharma, Novartis Pharma, Sanofi, MSD, Astellas Pharma, Eli Lilly Japan, Novo Nordisk, Sanwa Kagaku Kenkyusho, Kowa Com‑ pany, Shionogi, Nippon Boehringer Ingelheim, AstraZeneca, Kyowa Hakko Kirin, and Dainippon Sumitomo Pharma. Shiro Hinotsu received funding from Sanofi. Takeo Nakayama served as a medical advisor for Asahi Kasei Pharma. No other potential conflicts of interest relevant to this article were reported.
Publisher Copyright:
© 2016 Kondo et al.
PY - 2016/2/27
Y1 - 2016/2/27
N2 - Background: The 52-week monotherapy with the dipeptidyl peptidase-4 inhibitor sitagliptin and the sulphonylurea glimepiride on early-phase insulin secretion in Japanese patients with type 2 diabetes mellitus (T2DM) is not known. Methods: A randomized, parallel-group, open-label trial was conducted at 18 centers between February, 2011 and March, 2013. 171 outpatients with T2DM were recruited and randomly assigned to glimepiride or sitagliptin by minimization. Doses of glimepiride (0.25-1.0 mg/day) and sitagliptin (25-100 mg/day) were adjusted for hemoglobin A1c (HbA1c) > 6.9 %. Analyses were performed on full analysis set (FAS) of randomized subjects taking medications as allocated, and underwent 75 g oral glucose tolerance test (OGTTs) before and after treatment. The primary outcome was insulinogenic index to quantify early-phase insulin secretion after treatment, which was evaluated by analysis of covariance (ANCOVA). Results: Of 171 enrolled subjects, 68 in the sitagliptin group and 65 in the glimepiride group were included in the FAS (mean age, 64 years; baseline (HbA1c), 7.4 %). The primary outcome revealed a significantly higher insulinogenic index in the sitagliptin group than that in the glimepiride group (p = 0.036). Sitagliptin also reduced plasma glucose levels at 60 and 120 min during OGTT compared with glimepiride, while achieving a similar improvement in HbA1c during treatment. Body weight did not change in either of the two groups, and one case of hypoglycemia was observed in the glimepiride group. Conclusions: Sitagliptin shows better effects on insulinogenic index after 52-week treatment compared with glimepiride in Japanese patients with T2DM. Trial registration University hospital Medical Information Network (UMIN) Clinical Trials Registry, No.00004791.
AB - Background: The 52-week monotherapy with the dipeptidyl peptidase-4 inhibitor sitagliptin and the sulphonylurea glimepiride on early-phase insulin secretion in Japanese patients with type 2 diabetes mellitus (T2DM) is not known. Methods: A randomized, parallel-group, open-label trial was conducted at 18 centers between February, 2011 and March, 2013. 171 outpatients with T2DM were recruited and randomly assigned to glimepiride or sitagliptin by minimization. Doses of glimepiride (0.25-1.0 mg/day) and sitagliptin (25-100 mg/day) were adjusted for hemoglobin A1c (HbA1c) > 6.9 %. Analyses were performed on full analysis set (FAS) of randomized subjects taking medications as allocated, and underwent 75 g oral glucose tolerance test (OGTTs) before and after treatment. The primary outcome was insulinogenic index to quantify early-phase insulin secretion after treatment, which was evaluated by analysis of covariance (ANCOVA). Results: Of 171 enrolled subjects, 68 in the sitagliptin group and 65 in the glimepiride group were included in the FAS (mean age, 64 years; baseline (HbA1c), 7.4 %). The primary outcome revealed a significantly higher insulinogenic index in the sitagliptin group than that in the glimepiride group (p = 0.036). Sitagliptin also reduced plasma glucose levels at 60 and 120 min during OGTT compared with glimepiride, while achieving a similar improvement in HbA1c during treatment. Body weight did not change in either of the two groups, and one case of hypoglycemia was observed in the glimepiride group. Conclusions: Sitagliptin shows better effects on insulinogenic index after 52-week treatment compared with glimepiride in Japanese patients with T2DM. Trial registration University hospital Medical Information Network (UMIN) Clinical Trials Registry, No.00004791.
KW - Clinical trial
KW - DPP-4 inhibitor
KW - Insulin secretion
KW - Sulphonylurea
KW - Type 2 diabetes
UR - http://www.scopus.com/inward/record.url?scp=84959361340&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84959361340&partnerID=8YFLogxK
U2 - 10.1186/s13098-016-0131-y
DO - 10.1186/s13098-016-0131-y
M3 - Article
AN - SCOPUS:84959361340
VL - 8
JO - Diabetology and Metabolic Syndrome
JF - Diabetology and Metabolic Syndrome
SN - 1758-5996
IS - 1
M1 - 15
ER -