Advertisement

Diabetology International

, Volume 9, Issue 1, pp 56–65 | Cite as

Efficacy and safety of sitagliptin in elderly patients with type 2 diabetes mellitus and comparison of hypoglycemic action of concomitant medications: a subanalysis of the JAMP study

  • Noriko Ujihara
  • Hiroshi Sakura
  • Naotake Hashimoto
  • Kazuo Sasamoto
  • Hiroshi Ohashi
  • Sumiko Hasumi
  • Tadasu Kasahara
  • Osamu Tomonaga
  • Hideo Nunome
  • Masashi Honda
  • Yasuhiko Iwamoto
  • for the JAMP Study Investigators
Original Article
  • 249 Downloads

Abstract

Purpose

To determine the efficacy and safety of sitagliptin when used with some therapeutic drugs to treat elderly patients.

Methods

Sitagliptin (50 mg/day) was added to the pre-existing therapy for type 2 diabetes. Changes in the glycated hemoglobin (HbA1c) level after 3 months of treatment were compared with the baseline, and exploratory analysis was performed. These analyses were conducted as subanalyses of the JAMP study, which was an open-label observational study.

Results

For patients who were ≥65 years of age, the change in HbA1c level from baseline ranged from −0.50 to −0.87% at 3 months after starting treatment. There was no significant difference in the change in HbA1c level between the patients treated with different concomitant drugs. No significant difference in HbA1c variations at 3 and 12 months from baseline was noted among the three age groups (≥75, 65–74, and <65 years). Multiple regression analysis was performed, and it revealed that patients with higher HbA1c levels at baseline were likely to show decreased HbA1c levels, while those with higher triglyceride (TG) levels were unlikely to show decreased HbA1c levels.

Conclusion

Sitagliptin has the potential to both improve glycemic control and prevent hypoglycemia, and can be considered a potent alternative drug.

Keywords

DPP-4 inhibitor Prospective observational study Elderly patients Sitagliptin JAMP subanalysis Type 2 diabetes mellitus 

Notes

Acknowledgements

We would like to express our sincere gratitude to Mr. Shogo Shishikura (MSD K.K.) (Teikyo University Graduate School of Public Health, MPH) for scientific advice, including references, when revising the manuscript. We would also like to thank Nouvelle Place Inc. for conducting the data analyses.

Compliance with ethical standards

Funding

This study was funded by the Japan Diabetes Foundation.

Conflict of interest

Hiroshi Sakura received honoraria from Mitsubishi Tanabe Pharma Corporation and a research grant from Ono Pharmaceutical Co., Ltd. The other authors declare that they have no conflict of interest.

JAMP Study Investigators

Akiko Sato (Maruyama Internal Medicine Clinic); Akira Miyashita (Miyashita Surgery Clinic); Asako Kokubo (Kokubo Clinic); Atsuro Tsuchiya (Tsuchiya Clinic); Dai Hirohara (Hanazono Clinic); Daiji Kogure (Kogure Clinic); Daijo Kasahara (Kasahara Clinic); Hideki Tanaka (Internal Medicine, Seiwa Clinic); Hideki Tanaka (Internal Medicine, Nishiarai Hospital); Hideo Tezuka (Tezuka Clinic); Hiroyuki Kuroki (Internal Medicine, Johsai Hospital); Jun Ogino (Department of Diabetes, Endocrine and Metabolic Diseases, Tokyo Women’s Medical University Yachiyo Medical Center); Kanu Kin (Internal Medicine, Nishiarai Lifestyle-Related Diseases Clinic); Kanu Kin (Internal Medicine, Nishiarai Hospital); Kazuko Muto (Tokyo Women’s Medical University); Kazuo Suzuki (Kenkokan Suzuki Clinic of Internal Medicine); Keiko Iseki (Iseki Clinic); Keita Watanabe (Watanabe Clinic); Kenshi Higami (Higami Hospital); Kenzo Matsumura (Matsumura Gastroenterological Clinic); Kiyotaka Nakajima (Ebisu Clinic); Koki Shin (Shin Clinic); Kuniya Koizumi (Kuniya Clinic); Maki Saneshige (Mugishima Medical Clinic); Makio Sekine (Sekine Clinic); Makoto Yaida (Urban Heights Clinic); Mari Kiuchi (physician, Kanauchi Medical Clinic); Mari Mugishima (Mugishima Medical Clinic); Mari Osawa (Department of Diabetes Mellitus, Institute of Geriatrics, Tokyo Women’s Medical University); Masae Banno (Banno Medical Clinic); Masahiro Yamamoto (Internal Medicine 1, Shimane University Faculty of Medicine); Masatake Hiratsuka (Higashishinagawa Clinic); Masumi Hosoya (Yasui Clinic); Michika Atsuta (Internal Medicine, Nishiarai Lifestyle-Related Diseases Clinic); Mitsutoshi Kato (Kato Clinic of Internal Medicine); Miwa Morita (Internal Medicine 1, Shimane University Faculty of Medicine); Munehiro Miyamae (Johsai Hospital); Mutsumi Iijima (Abe Hospital); Naomi Okuyama (Shinjuku Mitsui Building Clinic); Nobuo Hisano (Mejiro Medical Clinic); Norihiro Tsuchiya (Omotesando Naika Ganka); Rie Wada (Kanauchi Medical Clinic); Rie Wada (Nerimasakuradai Clinic); Ryuji Momose (Momo Medical Clinic); Sachiko Otake (Tokyo Women’s Medical University); Satoko Maruyama (Shinjuku Mitsui Building Clinic); Satoru Takada (Internal Medicine, Social Welfare Corporation, Shineikai Takinogawa Hospital); Shigeki Dan (Ube Internal Medicine and Pediatrics Hospital); Shigeki Nishizawa (Nishizawa Medical Clinic); Shigeo Yamashita (Department of Diabetes and Endocrinology, JR Tokyo General Hospital); Shingo Saneshige (Internal Medicine, Kamiochiai Shin Clinic); Shinichi Teno (Teno Clinic); Shinji Tsuruta (Diabetic Medicine, Itabashi Chuo Medical Center); Shinobu Kumakura (Kumakura Medical Clinic); Sumiko Kijima (Abe Hospital); Takashi Kondo (Kondo Clinic); Takeo Onishi (Internal Medicine, Onishi Clinic); Taku Kudo (Internal Medicine, Social Welfare Corporation, Shineikai Takinogawa Hospital); Tatsushi Sugiura (Internal Medicine, Seiwa Clinic); Toshihiko Ishiguro (Kaname Clinic); Yasue Suzuki (Suzuki Medical Clinic); Yasuhiro Tomita (Nakanobu Clinic); Yasuko Takano (Department of Diabetes, Shiseikai Daini Hospital); Yoshihisa Akimoto (Akimoto Yoshi Medical Clinic); Yoshiko Odanaka (Ito Internal Medicine Pediatrics Clinic); Yoshimasa Tasaka (Tokyo Women’s Medical University); Yoshitaka Aiso (Internal Medicine, Diabetes, Aiso Clinic); Yukiko Inoue (Inoue Medical Clinic); Yukinobu Kobayashi (Kobayashi Clinic).

Ethical approval and consent to participate

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 a substitute for it was obtained from all patients before they were included in the study.

Supplementary material

13340_2017_330_MOESM1_ESM.docx (16 kb)
Supplementary material 1 (DOCX 15 kb)
13340_2017_330_MOESM2_ESM.docx (15 kb)
Supplementary material 2 (DOCX 15 kb)

References

  1. 1.
    Ministry of Health, Labour and Welfare. Summary of “Patient Survey”. Tokyo: Ministry of Health, Labour and Welfare; 2015. http://www.mhlw.go.jp/english/database/db-hss/sps_2014.html. Accessed 26 Jul 2017
  2. 2.
    Ministry of Health, Labour and Welfare. Results of “National Health and Nutrition Survey”. Tokyo: Ministry of Health, Labour and Welfare; 2015. http://www.mhlw.go.jp/stf/houdou/0000106405.html. Accessed 26 Jul 2017
  3. 3.
    Seltzer HS. Drug-induced hypoglycemia. A review of 1418 cases. Endocrinol Metab Clin North Am. 1989;18(1):163–83.PubMedGoogle Scholar
  4. 4.
    Araki A. Low well-being, cognitive impairment and visual impairment associated with functional disabilities in elderly Japanese patients with diabetes mellitus. Geriatr Gerontol Int. 2004;4(1):15–24.CrossRefGoogle Scholar
  5. 5.
    Ma F. Conversion of mild cognitive impairment to dementia among subjects with diabetes: a population-based study of incidence and risk factors with five years of follow-up. J Alzheimers Dis. 2015;43(4):1441–9.PubMedGoogle Scholar
  6. 6.
    Solini A. Renal insufficiency and cardiovascular events study group: age, renal dysfunction, cardiovascular disease, and antihyperglycemic treatment in type 2 diabetes mellitus. J Am Geriatr Soc. 2013;61(8):1253–61.CrossRefPubMedGoogle Scholar
  7. 7.
    Huang ES. Rates of complications and mortality in older diabetes patients: the diabetes and aging study. JAMA Intern Med. 2014;174(2):251–8.CrossRefPubMedPubMedCentralGoogle Scholar
  8. 8.
    Lind M. The relationship between glycaemic control and heart failure in 83,021 patients with type 2 diabetes. Diabetologia. 2012;55(11):2946–53.CrossRefPubMedGoogle Scholar
  9. 9.
    Bremer JP. Hypoglycemia unawareness in older compared with middle-aged patients with type 2 diabetes. Diabetes Care. 2009;32(8):1513–7.Google Scholar
  10. 10.
    Aschner P. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care. 2006;29(12):2632–7.CrossRefPubMedGoogle Scholar
  11. 11.
    Charbonnel B. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone. Diabetes Care. 2006;29(12):2638–43.CrossRefPubMedGoogle Scholar
  12. 12.
    Rosenstock J. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing pioglitazone therapy in patients with type 2 diabetes: a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2006;28(10):1556–68.CrossRefPubMedGoogle Scholar
  13. 13.
    Shankar R. A comparison of glycaemic effects of sitagliptin and sulfonylureas in elderly patients with type 2 diabetes mellitus. Int J Clin Pract. 2015;69(6):626–31.CrossRefPubMedGoogle Scholar
  14. 14.
    Hartley P. Efficacy and tolerability of sitagliptin compared with glimepiride in elderly patients with type 2 diabetes mellitus and inadequate glycemic control: a randomized, double-blind, non-inferiority trial. Drugs Aging. 2015;32(6):469–76.Google Scholar
  15. 15.
    Umezawa S. Two-year assessment of the efficacy and safety of sitagliptin in elderly patients with type 2 diabetes: post hoc analysis of the ASSET-K study. BMC Endocr Disord. 2015;15(34):1–8.Google Scholar
  16. 16.
    Hermansen K. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes Obes Metab. 2007;9(5):733–45.CrossRefPubMedGoogle Scholar
  17. 17.
    Sakura H. Effect of sitagliptin on blood glucose control in patients with type 2 diabetes mellitus who are treatment naive or poorly responsive to existing antidiabetic drugs: the JAMP study. BMC Endocr Disord. 2016;16(1):70.Google Scholar
  18. 18.
    Seino Y, Nanjo K, Tajima N, Kadowaki T, Kashiwagi A, Araki E, Ito C, Inagaki N, Iwamoto Y, Kasuga M, Hanafusa T, Haneda M, Ueki K. Report of the Committee on the Classification and Diagnostic Criteria of Diabetes Mellitus (revision for international harmonization of HbA1c in Japan). J Jpn Diabetes Soc. 2012;55(7):485–504.Google Scholar
  19. 19.
    Barzilia N. Efficacy and tolerability of sitagliptin monotherapy in elderly patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial. Curr Med Res Opin. 2011;27(5):1049–58.CrossRefGoogle Scholar
  20. 20.
    Round E. Safety of sitagliptin in elderly patients with type 2 diabetes: a pooled analysis of 25 clinical studies. Drugs Aging. 2014;31(3):203–14.CrossRefPubMedGoogle Scholar
  21. 21.
    Nelson EA. Aged heterogeneity: fact or fiction? The fate of diversity in gerontological research. Gerontologist. 1992;32(1):17–23.CrossRefPubMedGoogle Scholar
  22. 22.
    Goto A. Severe hypoglycaemia and cardiovascular disease: systematic review and meta-analysis with bias analysis. BMJ. 2013;347:f4533.CrossRefPubMedGoogle Scholar
  23. 23.
    The Japan Diabetes Society. Diabetes in the elderly (including dementia). In: Guideline for the treatment for diabetes in Japan 2016. Tokyo: Nankodo; 2016. p. 411–48.Google Scholar
  24. 24.
    Scott R. Efficacy and tolerability of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy over 12 weeks in patients with type 2 diabetes. Int J Clin Pract. 2007;61(1):171–80.CrossRefPubMedGoogle Scholar
  25. 25.
    Nonaka K. Efficacy and safety of sitagliptin monotherapy in Japanese patients with type 2 diabetes. Diabetes Res Clin Pract. 2008;79(2):291–8.CrossRefPubMedGoogle Scholar
  26. 26.
    Tada Y. Long-term efficacy and safety of sitagliptin in elderly patients with type 2 diabetes mellitus. Intern Med. 2016;55(10):1275–8.CrossRefPubMedGoogle Scholar
  27. 27.
    Ching-Jung H. The durability of sitagliptin in elderly patients with type 2 diabetes. Clin Interv Aging. 2014;7(9):1905–11.Google Scholar
  28. 28.
    Harris MI. Prevalence of diabetes, impaired fasting glucose, and impaired glucose tolerance in US adults: the Third National Health and Examination Survey. Diabetes Care. 1998;21(4):518–24.CrossRefPubMedGoogle Scholar
  29. 29.
    Suh DC. Comorbid conditions and glycemic control in elderly patients with type 2 diabetes mellitus, 1988 to 1994 to 1999 to 2004. J Am Geriatr Soc. 2008;56(3):484–92.CrossRefPubMedGoogle Scholar
  30. 30.
    Bosu R. Mechanisms of the age-associated deterioration in glucose tolerance: contribution of alterations in insulin secretion, action, and clearance. Diabetes. 2003;52(7):1738–48.CrossRefGoogle Scholar
  31. 31.
    Sakurai T. Age-associated increase in abdominal obesity and insulin resistance, and usefulness of AHA/NHLBI definition of metabolic syndrome for predicting cardiovascular disease in Japanese elderly with type 2 diabetes mellitus. Gerontology. 2010;56:141–9.CrossRefPubMedGoogle Scholar
  32. 32.
    Zhuravlyova LV. The factors of the progression of metabolic disorders in the pancreas in patients with associated clinical variants of the chronic pancreatitis and type 2 diabetes mellitus. Lik Sprava. 2015;2015(5–6):46–51.Google Scholar
  33. 33.
    Iwamoto Y. Dose-ranging efficacy of sitagliptin, a dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus. Endocr J. 2010;57(5):383–94.CrossRefPubMedGoogle Scholar

Copyright information

© The Japan Diabetes Society 2017

Authors and Affiliations

  • Noriko Ujihara
    • 1
  • Hiroshi Sakura
    • 2
  • Naotake Hashimoto
    • 3
  • Kazuo Sasamoto
    • 4
  • Hiroshi Ohashi
    • 5
  • Sumiko Hasumi
    • 6
  • Tadasu Kasahara
    • 7
  • Osamu Tomonaga
    • 8
  • Hideo Nunome
    • 9
  • Masashi Honda
    • 10
  • Yasuhiko Iwamoto
    • 11
  • for the JAMP Study Investigators
  1. 1.Department of Medicine, Diabetes Center, Institute of GeriatricsTokyo Women’s Medical UniversityTokyoJapan
  2. 2.Department of MedicineTokyo Women’s Medical University, Medical Center EastTokyoJapan
  3. 3.Department of Diabetes, Endocrine and Metabolic DiseasesTokyo Women’s Medical University Yachiyo Medical CenterYachiyo-shiJapan
  4. 4.Internal MedicineSuzuki ClinicTokyoJapan
  5. 5.Internal MedicineOyama East ClinicOyama-shiJapan
  6. 6.Internal MedicineNishiyamado-Keiwa HospitalNaka-shiJapan
  7. 7.Josai HospitalTokyoJapan
  8. 8.Diabetes and Lifestyle CenterTomonaga ClinicTokyoJapan
  9. 9.Diabetes Center, Edogawa Hospital, Medical Plaza ShinozakiTokyoJapan
  10. 10.Nishikawa ClinicTokyoJapan
  11. 11.Tokyo Women’s Medical University/The Institute for Adult Diseases, Asahi Life FoundationTokyoJapan

Personalised recommendations