Sitagliptin monotherapy has better effect on insulinogenic index than glimepiride monotherapy in Japanese patients with type 2 diabetes mellitus: A 52-week, multicenter, parallel-group randomized controlled trial

Yaeko Kondo, Norio Harada, Akihiro Hamasaki, Shizuka Kaneko, Koichiro Yasuda, Eiichi Ogawa, Shin Ichi Harashima, Hiroko Yoneda, Yoshihito Fujita, Norikazu Kitano, Yoshio Nakamura, Fujio Matsuo, Megumi Shinji, Shiro Hinotsu, Takeo Nakayama, Nobuya Inagaki

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Abstract

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.

Original languageEnglish
Article number15
JournalDiabetology and Metabolic Syndrome
Volume8
Issue number1
DOIs
Publication statusPublished - Feb 27 2016

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glimepiride
Type 2 Diabetes Mellitus
Randomized Controlled Trials
Hemoglobins
Glucose Tolerance Test
Insulin
Dipeptidyl-Peptidase IV Inhibitors
Body Weight Changes
Information Services
Sitagliptin Phosphate
Therapeutics
Hypoglycemia
Registries

Keywords

  • Clinical trial
  • DPP-4 inhibitor
  • Insulin secretion
  • Sulphonylurea
  • Type 2 diabetes

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Internal Medicine

Cite this

Sitagliptin monotherapy has better effect on insulinogenic index than glimepiride monotherapy in Japanese patients with type 2 diabetes mellitus : A 52-week, multicenter, parallel-group randomized controlled trial. / Kondo, Yaeko; Harada, Norio; Hamasaki, Akihiro; Kaneko, Shizuka; Yasuda, Koichiro; Ogawa, Eiichi; Harashima, Shin Ichi; Yoneda, Hiroko; Fujita, Yoshihito; Kitano, Norikazu; Nakamura, Yoshio; Matsuo, Fujio; Shinji, Megumi; Hinotsu, Shiro; Nakayama, Takeo; Inagaki, Nobuya.

In: Diabetology and Metabolic Syndrome, Vol. 8, No. 1, 15, 27.02.2016.

Research output: Contribution to journalArticle

Kondo, Y, Harada, N, Hamasaki, A, Kaneko, S, Yasuda, K, Ogawa, E, Harashima, SI, Yoneda, H, Fujita, Y, Kitano, N, Nakamura, Y, Matsuo, F, Shinji, M, Hinotsu, S, Nakayama, T & Inagaki, N 2016, 'Sitagliptin monotherapy has better effect on insulinogenic index than glimepiride monotherapy in Japanese patients with type 2 diabetes mellitus: A 52-week, multicenter, parallel-group randomized controlled trial', Diabetology and Metabolic Syndrome, vol. 8, no. 1, 15. https://doi.org/10.1186/s13098-016-0131-y
Kondo, Yaeko ; Harada, Norio ; Hamasaki, Akihiro ; Kaneko, Shizuka ; Yasuda, Koichiro ; Ogawa, Eiichi ; Harashima, Shin Ichi ; Yoneda, Hiroko ; Fujita, Yoshihito ; Kitano, Norikazu ; Nakamura, Yoshio ; Matsuo, Fujio ; Shinji, Megumi ; Hinotsu, Shiro ; Nakayama, Takeo ; Inagaki, Nobuya. / Sitagliptin monotherapy has better effect on insulinogenic index than glimepiride monotherapy in Japanese patients with type 2 diabetes mellitus : A 52-week, multicenter, parallel-group randomized controlled trial. In: Diabetology and Metabolic Syndrome. 2016 ; Vol. 8, No. 1.
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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

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

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