Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin compared with alpha-glucosidase inhibitor in Japanese patients with type 2 diabetes inadequately controlled on metformin or pioglitazone alone (Study for an Ultimate Combination Therapy to Control Diabetes with Sitagliptin-1): A multicenter, randomized, open-label, non-inferiority trial

on behalf of the SUCCESS Study Group

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Aims/Introduction: To assess the efficacy and safety of sitagliptin compared with α-glucosidase inhibitors in Japanese patients with type 2 diabetes inadequately controlled by metformin or pioglitazone alone. Materials and Methods: In the present multicenter, randomized, open-label, parallel-group, active-controlled, non-inferiority trial, 119 patients aged 20-79 years with type 2 diabetes who had glycated hemoglobin 6.9-8.8% on stable metformin (500-1,500 mg/day) or pioglitazone (15-30 mg/day) alone were randomly assigned (1:1) to receive the addition of sitagliptin (50 mg/day) or an α-glucosidase inhibitor (0.6 mg/day voglibose or 150 mg/day miglitol) for 24 weeks. The primary end-point was change in glycated hemoglobin from baseline to week 12. All data were analyzed according to the intention-to-treat principle. Results: After 12 weeks, reductions in adjusted mean glycated hemoglobin from baseline were -0.70% in sitagliptin and -0.21% in the α-glucosidase inhibitor groups respectively; between-group difference was -0.49% (95% confidence interval -0.66 to -0.32, P < 0.0001), meeting the predefined non-inferiority criterion (0.25%) and showing statistical significance. This statistical significance also continued after 24 weeks. Although sitagliptin did not affect bodyweight, α-glucosidase inhibitors decreased bodyweight significantly from baseline (-0.39 kg; P = 0.0079). Gastrointestinal disorders were significantly lower with sitagliptin than with an α-glucosidase inhibitor (6 [10.3%] patients vs 23 [39.7%]; P = 0.0003). Minor hypoglycemia occurred in two patients (3.5%) in each group. Conclusions: Sitagliptin showed greater efficacy and better tolerability than an α-glucosidase inhibitor when added to stable doses of metformin or pioglitazone. These findings support the use of sitagliptin in Japanese patients with type 2 diabetes inadequately controlled by insulin-sensitizing agents. This trial was registered with UMIN (no. 000004675).

Original languageEnglish
Pages (from-to)182-191
Number of pages10
JournalJournal of Diabetes Investigation
Volume6
Issue number2
DOIs
Publication statusPublished - 2015 Mar 1
Externally publishedYes

Fingerprint

pioglitazone
Dipeptidyl-Peptidase IV Inhibitors
Glucosidases
Metformin
Type 2 Diabetes Mellitus
Safety
Glycosylated Hemoglobin A
miglitol
Therapeutics
Sitagliptin Phosphate
Glycoside Hydrolase Inhibitors
Hypoglycemia

Keywords

  • Alpha-glucosidase inhibitor
  • Combination drug therapy
  • Sitagliptin

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

@article{fce46a9d63a24705bdee48eac5b0b08a,
title = "Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin compared with alpha-glucosidase inhibitor in Japanese patients with type 2 diabetes inadequately controlled on metformin or pioglitazone alone (Study for an Ultimate Combination Therapy to Control Diabetes with Sitagliptin-1): A multicenter, randomized, open-label, non-inferiority trial",
abstract = "Aims/Introduction: To assess the efficacy and safety of sitagliptin compared with α-glucosidase inhibitors in Japanese patients with type 2 diabetes inadequately controlled by metformin or pioglitazone alone. Materials and Methods: In the present multicenter, randomized, open-label, parallel-group, active-controlled, non-inferiority trial, 119 patients aged 20-79 years with type 2 diabetes who had glycated hemoglobin 6.9-8.8{\%} on stable metformin (500-1,500 mg/day) or pioglitazone (15-30 mg/day) alone were randomly assigned (1:1) to receive the addition of sitagliptin (50 mg/day) or an α-glucosidase inhibitor (0.6 mg/day voglibose or 150 mg/day miglitol) for 24 weeks. The primary end-point was change in glycated hemoglobin from baseline to week 12. All data were analyzed according to the intention-to-treat principle. Results: After 12 weeks, reductions in adjusted mean glycated hemoglobin from baseline were -0.70{\%} in sitagliptin and -0.21{\%} in the α-glucosidase inhibitor groups respectively; between-group difference was -0.49{\%} (95{\%} confidence interval -0.66 to -0.32, P < 0.0001), meeting the predefined non-inferiority criterion (0.25{\%}) and showing statistical significance. This statistical significance also continued after 24 weeks. Although sitagliptin did not affect bodyweight, α-glucosidase inhibitors decreased bodyweight significantly from baseline (-0.39 kg; P = 0.0079). Gastrointestinal disorders were significantly lower with sitagliptin than with an α-glucosidase inhibitor (6 [10.3{\%}] patients vs 23 [39.7{\%}]; P = 0.0003). Minor hypoglycemia occurred in two patients (3.5{\%}) in each group. Conclusions: Sitagliptin showed greater efficacy and better tolerability than an α-glucosidase inhibitor when added to stable doses of metformin or pioglitazone. These findings support the use of sitagliptin in Japanese patients with type 2 diabetes inadequately controlled by insulin-sensitizing agents. This trial was registered with UMIN (no. 000004675).",
keywords = "Alpha-glucosidase inhibitor, Combination drug therapy, Sitagliptin",
author = "{on behalf of the SUCCESS Study Group} and Hidetaka Yokoh and Kazuki Kobayashi and Yasunori Sato and Minoru Takemoto and Daigaku Uchida and Azuma Kanatsuka and Nobuichi Kuribayashi and Takashi Terano and Naotake Hashimoto and Kenichi Sakurai and Hideki Hanaoka and Ko Ishikawa and Shunichiro Onishi and Koutaro Yokote",
year = "2015",
month = "3",
day = "1",
doi = "10.1111/jdi.12282",
language = "English",
volume = "6",
pages = "182--191",
journal = "Journal of Diabetes Investigation",
issn = "2040-1116",
publisher = "Blackwell Publishing Asia Pty Ltd",
number = "2",

}

TY - JOUR

T1 - Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin compared with alpha-glucosidase inhibitor in Japanese patients with type 2 diabetes inadequately controlled on metformin or pioglitazone alone (Study for an Ultimate Combination Therapy to Control Diabetes with Sitagliptin-1)

T2 - A multicenter, randomized, open-label, non-inferiority trial

AU - on behalf of the SUCCESS Study Group

AU - Yokoh, Hidetaka

AU - Kobayashi, Kazuki

AU - Sato, Yasunori

AU - Takemoto, Minoru

AU - Uchida, Daigaku

AU - Kanatsuka, Azuma

AU - Kuribayashi, Nobuichi

AU - Terano, Takashi

AU - Hashimoto, Naotake

AU - Sakurai, Kenichi

AU - Hanaoka, Hideki

AU - Ishikawa, Ko

AU - Onishi, Shunichiro

AU - Yokote, Koutaro

PY - 2015/3/1

Y1 - 2015/3/1

N2 - Aims/Introduction: To assess the efficacy and safety of sitagliptin compared with α-glucosidase inhibitors in Japanese patients with type 2 diabetes inadequately controlled by metformin or pioglitazone alone. Materials and Methods: In the present multicenter, randomized, open-label, parallel-group, active-controlled, non-inferiority trial, 119 patients aged 20-79 years with type 2 diabetes who had glycated hemoglobin 6.9-8.8% on stable metformin (500-1,500 mg/day) or pioglitazone (15-30 mg/day) alone were randomly assigned (1:1) to receive the addition of sitagliptin (50 mg/day) or an α-glucosidase inhibitor (0.6 mg/day voglibose or 150 mg/day miglitol) for 24 weeks. The primary end-point was change in glycated hemoglobin from baseline to week 12. All data were analyzed according to the intention-to-treat principle. Results: After 12 weeks, reductions in adjusted mean glycated hemoglobin from baseline were -0.70% in sitagliptin and -0.21% in the α-glucosidase inhibitor groups respectively; between-group difference was -0.49% (95% confidence interval -0.66 to -0.32, P < 0.0001), meeting the predefined non-inferiority criterion (0.25%) and showing statistical significance. This statistical significance also continued after 24 weeks. Although sitagliptin did not affect bodyweight, α-glucosidase inhibitors decreased bodyweight significantly from baseline (-0.39 kg; P = 0.0079). Gastrointestinal disorders were significantly lower with sitagliptin than with an α-glucosidase inhibitor (6 [10.3%] patients vs 23 [39.7%]; P = 0.0003). Minor hypoglycemia occurred in two patients (3.5%) in each group. Conclusions: Sitagliptin showed greater efficacy and better tolerability than an α-glucosidase inhibitor when added to stable doses of metformin or pioglitazone. These findings support the use of sitagliptin in Japanese patients with type 2 diabetes inadequately controlled by insulin-sensitizing agents. This trial was registered with UMIN (no. 000004675).

AB - Aims/Introduction: To assess the efficacy and safety of sitagliptin compared with α-glucosidase inhibitors in Japanese patients with type 2 diabetes inadequately controlled by metformin or pioglitazone alone. Materials and Methods: In the present multicenter, randomized, open-label, parallel-group, active-controlled, non-inferiority trial, 119 patients aged 20-79 years with type 2 diabetes who had glycated hemoglobin 6.9-8.8% on stable metformin (500-1,500 mg/day) or pioglitazone (15-30 mg/day) alone were randomly assigned (1:1) to receive the addition of sitagliptin (50 mg/day) or an α-glucosidase inhibitor (0.6 mg/day voglibose or 150 mg/day miglitol) for 24 weeks. The primary end-point was change in glycated hemoglobin from baseline to week 12. All data were analyzed according to the intention-to-treat principle. Results: After 12 weeks, reductions in adjusted mean glycated hemoglobin from baseline were -0.70% in sitagliptin and -0.21% in the α-glucosidase inhibitor groups respectively; between-group difference was -0.49% (95% confidence interval -0.66 to -0.32, P < 0.0001), meeting the predefined non-inferiority criterion (0.25%) and showing statistical significance. This statistical significance also continued after 24 weeks. Although sitagliptin did not affect bodyweight, α-glucosidase inhibitors decreased bodyweight significantly from baseline (-0.39 kg; P = 0.0079). Gastrointestinal disorders were significantly lower with sitagliptin than with an α-glucosidase inhibitor (6 [10.3%] patients vs 23 [39.7%]; P = 0.0003). Minor hypoglycemia occurred in two patients (3.5%) in each group. Conclusions: Sitagliptin showed greater efficacy and better tolerability than an α-glucosidase inhibitor when added to stable doses of metformin or pioglitazone. These findings support the use of sitagliptin in Japanese patients with type 2 diabetes inadequately controlled by insulin-sensitizing agents. This trial was registered with UMIN (no. 000004675).

KW - Alpha-glucosidase inhibitor

KW - Combination drug therapy

KW - Sitagliptin

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U2 - 10.1111/jdi.12282

DO - 10.1111/jdi.12282

M3 - Article

AN - SCOPUS:84923651207

VL - 6

SP - 182

EP - 191

JO - Journal of Diabetes Investigation

JF - Journal of Diabetes Investigation

SN - 2040-1116

IS - 2

ER -