Efficacy and safety of sitagliptin added to insulin in Japanese patients with type 2 Diabetes: The EDIT randomized trial

Seiji Sato, Yoshifumi Saisho, Kinsei Kou, Shu Meguro, Masami Tanaka, Junichiro Irie, Toshihide Kawai, Hiroshi Itoh

Research output: Contribution to journalArticle

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Abstract

Aims: To clarify the efficacy and safety of adding sitagliptin to insulin therapy in Japanese patients with suboptimally controlled type 2 diabetes (T2DM). Study Design and Methods: This was a 24-week, prospective, randomized, open-labeled, controlled trial. Patients with T2DM who were suboptimally controlled despite receiving at least twice daily injection of insulin were enrolled in the study. The patients were randomized to continuation of insulin treatment (Insulin group) or addition of sitagliptin 50 to 100 mg daily to insulin treatment (Ins+Sita group). The primary outcome was change in HbA1c at week 24. Results: Adding sitagliptin to insulin significantly reduced HbA1c from 7.9 ± 1.0% at baseline to 7.0 ± 0.8% at week 24 (P <0.0001), while there was no significant change in HbA1c in the Insulin group (7.8 ± 0.7% vs. 7.8 ± 1.1%, P=0.32). The difference in HbA1c reduction between the groups was 0.9% (95% confidence interval, 0.4 to 1.5, P=0.01). There was no significant weight gain in either group. Incidence of hypoglycemia was significantly reduced in the Ins+Sita group compared with the Insulin group. Treatment satisfaction was improved in the Ins+Sita group. Baseline HbA1c level and beta cell function were associated with the magnitude of reduction in HbA1c in the Ins+Sita group. Conclusion: Adding sitagliptin to insulin reduced HbA1c without weight gain or increase in hypoglycemia, and improved treatment satisfaction in Japanese patients with T2DM who were suboptimally controlled despite at least twice daily injection of insulin.

Original languageEnglish
Article numbere0121988
JournalPLoS One
Volume10
Issue number3
DOIs
Publication statusPublished - 2015 Mar 27

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Medical problems
noninsulin-dependent diabetes mellitus
glycohemoglobin
Type 2 Diabetes Mellitus
insulin
Insulin
Safety
hypoglycemia
Hypoglycemia
Weight Gain
weight gain
injection
Sitagliptin Phosphate
Therapeutics
Injections
confidence interval
experimental design
incidence
Confidence Intervals
Incidence

ASJC Scopus subject areas

  • Agricultural and Biological Sciences(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Medicine(all)

Cite this

Efficacy and safety of sitagliptin added to insulin in Japanese patients with type 2 Diabetes : The EDIT randomized trial. / Sato, Seiji; Saisho, Yoshifumi; Kou, Kinsei; Meguro, Shu; Tanaka, Masami; Irie, Junichiro; Kawai, Toshihide; Itoh, Hiroshi.

In: PLoS One, Vol. 10, No. 3, e0121988, 27.03.2015.

Research output: Contribution to journalArticle

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AU - Tanaka, Masami

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AU - Kawai, Toshihide

AU - Itoh, Hiroshi

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