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. 2017 Dec 16;9(3):158-167.
doi: 10.1007/s13340-017-0340-0. eCollection 2018 Jul.

Factors involved in decreasing the therapeutic effect of sitagliptin: a subanalysis of the JAMP study

Hideo Nunome  1 , Hiroshi Sakura  2 , Naotake Hashimoto  3 , Kazuo Sasamoto  4 , Hiroshi Ohashi  5 , Sumiko Hasumi  6 , Noriko Ujihara  7 , Tadasu Kasahara  8 , Osamu Tomonaga  9 , Masashi Honda  10 , Yasuhiko Iwamoto  11 ; JAMP Study Investigators
Collaborators, Affiliations

Factors involved in decreasing the therapeutic effect of sitagliptin: a subanalysis of the JAMP study

Hideo Nunome et al. Diabetol Int. .

Abstract

Objective: As a subanalysis of the Januvia Multicenter Prospective Trial in Type 2 Diabetes (JAMP study), we examined factors that decreased blood glucose control effect of sitagliptin after 3 months and patients requiring an addition or increase of diabetes treatment.

Methods: We selected patients in whom glycated hemoglobin (HbA1c) levels decreased by month 3 after initiation of sitagliptin treatment and conducted two analyses: (1) in patients who did not change drugs until month 12, we compared changes in HbA1c levels between concomitant drugs and examined factors that decreased blood glucose control effect of sitagliptin; (2) compared changes in HbA1c levels and backgrounds between patients who did and did not require an addition to or increased dose of the antidiabetic agent.

Results: Four hundred and ninety-eight patients were chosen. In 369 patients without drug change until month 12, changes in HbA1c levels during months 3-12 were not significantly different among concomitant drugs; factors causing rebound HbA1c were smoking and weight gain. Patient characteristics were compared between those who did and did not require an additional drug or a dose increase (n = 114) (n = 384). Drug changes were associated with longer disease duration, younger age, higher rate of smoking, and higher degree of insulin resistance but not with concomitantly administered drugs.

Conclusion: Smoking and weight gain were factors that decreased the effect of sitagliptin on reducing blood glucose levels. Differences in concomitant drugs did not affect sitagliptin's effects on glycemic control. A dose increase or the addition of the antidiabetic drug was not associated with concomitant drugs.

Keywords: DPP4-inhibitor; Decreasing the therapeutic effect; HbA1c rebound factor; Sitagliptin; Type 2 diabetes mellitus.

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Conflict of interest statement

Hiroshi Sakura received honoraria from Mitsubishi Tanabe Pharma Corporation and research grant from Ono Pharmaceutical Co., Ltd. Other authors declare that they have no conflict of interest.All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later versions. The ethics committee at the Tokyo Women’s Medical University approved the study (Approval Number: 2064) on 11 January 2011. Informed consent or substitute was obtained from all patients included in the study.

Figures

Fig. 1
Fig. 1
Study design. *Criteria on poor glycemic control: HbA1c ≥6.9% or fasting blood glucose ≥130 mg/dl. #Study-specific test (arbitrary): GA, anhydroglucitol (1,5-AG), C-peptide, proinsulin/insulin ratio
Fig. 2
Fig. 2
Analysis flow
Fig. 3
Fig. 3
Patient flow
Fig. 4
Fig. 4
Changes in glycated hemoglobin (HbA1c) levels by drug addition/dose increase. *P < 0.001 vs month 0; repeated measures analysis of variance (ANOVA) with Bonferroni correction. † P = 0.002; Student’s t test
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