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Alogliptin as an initial therapy in patients with newly diagnosed, drug naïve type 2 diabetes: a randomized, control trial

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Abstract

The objectives of this study is to evaluate the efficacy and safety of alogliptin versus very low fat/calorie traditional Japanese diet (non-inferiority trial) as an initial therapy for newly diagnosed, drug naïve subjects with type 2 diabetes (T2DM). Study design was prospective, randomized, non-double-blind, controlled trial. The study was conducted at outpatient units of municipal hospital. Patients were newly diagnosed, drug naïve patients who visited the outpatient units. The patients randomly received 12.5–25 mg/day alogliptin (n = 25) or severe low calorie traditional Japanese diet (n = 26). The procedure of this trial was assessed by the consolidated standards of reporting trials statement. The primary end point was the change of HbA1c at 3 months. Secondary end points included the changes of fasting blood glucose, insulin, homeostasis model assessment-R (HOMA-R), HOMA-B, body mass index (BMI), and lipid parameters. Similar, significant reductions of HbA1c levels were observed in both groups (from 10.51 to 8.74% for alogliptin and from 10.01 to 8.39% for traditional Japanese diet) without any clinically significant adverse events. In the alogliptin group, some subjects (16%) had mild hypoglycemic evens which could be managed by taking glucose drinks by themselves. HOMA-B significantly increased in both groups with varying degrees, whereas HOMA-R significantly decreased only in the Japanese diet group. Atherogenic lipids, such as, total cholesterol, non-high density lipoprotein cholesterol, and low density lipoprotein cholesterol levels significantly decreased in both groups. BMI had no change in the alogliptin group, whereas it significantly decreased in the Japanese diet group. (1) Concerning its glycemic efficacy, alogliptin is effective and non-inferior to traditional Japanese diet as an initial therapeutic option for newly diagnosed T2DM. However, regarding the reductions of body weight and insulin resistance, traditional Japanese diet is superior. (2) Both alogliptin and traditional Japanese diet have favorable effects on atherogenic lipid profiles.

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References

  1. J.J. Neumiller, Clinical pharmacology of incretin therapies for type 2 diabetes mellitus: implications for treatment. Clin. Ther. 33(5), 528–576 (2011)

    Article  PubMed  CAS  Google Scholar 

  2. J.A. Lovshin, D.J. Drucker, Incretin-based therapies for type 2 diabetes mellitus. Nat. Rev. Endocrinol. 5(5), 262–269 (2009)

    Article  PubMed  CAS  Google Scholar 

  3. E. Kutoh, Sitagliptin is effective and safe as add-on to insulin in patients with absolute insulin deficiency: a case series. J. Med. Case Rep. 5, 117 (2011)

    Article  Google Scholar 

  4. J.R. White, Alogliptin for the treatment of type 2 diabetes. Drugs Today 47(2), 99–107 (2011)

    PubMed  CAS  Google Scholar 

  5. K. Takeuchi, T. Fujita, S. Hiroi, Pharmacological and clinical profile of alogliptin benzoate (NESINA®). Nihon Yakurigaku Zasshi 137(1), 43–50 (2011)

    Article  PubMed  CAS  Google Scholar 

  6. L.J. Scott, Alogliptin: a review of its use in the management of type 2 diabetes mellitus. Drugs 70(15), 2051–2072 (2010)

    Article  PubMed  CAS  Google Scholar 

  7. R.A. DeFronzo, P.R. Fleck, C.A. Wilson, Q. Mekkim, Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes and inadequate glycemic control. Diabetes Care 31(12), 2315–2317 (2008)

    Article  PubMed  CAS  Google Scholar 

  8. R. Andukuri, A. Drincic, M. Rendell, Alogliptin: a new addition to the class of DPP-4 inhibitors. Diabetes Metab. Syndr. Obes. 2, 117–126 (2009)

    PubMed  CAS  Google Scholar 

  9. D.M. Nathan, J.B. Buse, M.B. Davidson, E. Ferrannini, R.R. Holman, R. Sherwin, B. Zinman, American Diabetes Association; European Association for Study of Diabetes, Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 32(1), 193–203 (2009)

    Article  PubMed  CAS  Google Scholar 

  10. D.M. Nathan, J.B. Buse, M.B. Davidson, E. Ferrannini, R.R. Holman, R. Sherwin, B. Zinman, American Diabetes Association; European Association for Study of Diabetes, Medical management of hyperglycaemia in type 2 diabetes mellitus: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia 52(1), 17–30 (2009)

    Article  PubMed  CAS  Google Scholar 

  11. M. Tominaga, Diagnostic criteria for diabetes mellitus. Rinsho Byori 47(10), 901–908 (1999)

    PubMed  CAS  Google Scholar 

  12. K.F. Schulz, D.G. Altman, D. Moher, CONSORT Group, CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann. Intern. Med. 152(11), 726–732 (2010)

    PubMed  Google Scholar 

  13. K. Cwiertka, A note on the making of culinary tradition—an example of modern Japan. Appetite 30(2), 117–128 (1998)

    Article  PubMed  CAS  Google Scholar 

  14. K. Shiwaku, M. Hashimoto, A. Nogi, K. Kitajima, M. Yamasaki, Traditional Japanese dietary basics: a solution for modern health issues? Lancet 363(9422), 1737–1738 (2004)

    Article  PubMed  Google Scholar 

  15. Y. Ma, B.C. Olendzki, P.A. Merriam, D.E. Chiriboga, A.L. Culver, W. Li, J.R. Hébert, I.S. Ockene, J.A. Griffith, S.L. Pagoto, A randomized clinical trial comparing low-glycemic index versus ADA dietary education among individuals with type 2 diabetes. Nutrition 24(1), 45–56 (2008)

    Article  PubMed  CAS  Google Scholar 

  16. D.R. Matthews, J.P. Hosker, A.S. Rudenski, B.A. Naylor, D.F. Treacher, R.C. Turner, Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia 28(7), 412–419 (1985)

    Article  PubMed  CAS  Google Scholar 

  17. J.A. Davidson, Advances in therapy for type 2 diabetes: GLP-1 receptor agonists and DPP-4 inhibitors. Cleve. Clin. J. Med. 76(Suppl 5), S28–S38 (2009)

    Article  PubMed  Google Scholar 

  18. J. White, Efficacy and safety of incretin based therapies: clinical trial data. J. Am. Pharm. Assoc. 49(Suppl 1), S30–S40 (2009)

    Article  Google Scholar 

  19. F. Giorgino, A. Leonardini, A. Natalicchio, L. Laviola, Multifactorial intervention in type 2 diabetes: the promise of incretin-based therapies. J. Endocrinol. Invest. 34(1), 69–77 (2011)

    PubMed  CAS  Google Scholar 

  20. Z. Shah, T. Kampfrath, J.A. Deiuliis, J Zhong, C. Pineda, Z. Ying, X. Xu, B. Lu, S. Moffatt-Bruce, R. Durairaj, Q. Sun, G. Mihai, A. Maiseyeu, S. Rajagopalan, Long-term dipeptidyl-peptidase 4 inhibition reduces atherosclerosis and inflammation via effects on monocyte recruitment and chemotaxis. Circulation (2011). doi:10.1161/CIRCULATIONAHA.111.041418

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Acknowledgments

The author thanks Drs. Jan Wajs, Gaku Miyakawa, Susumu Touchika, Sachiko Yokoyama, and Hiroshi Kawashima for discussions and Naoki Takeda for the advice of statistical analysis.

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The authors have nothing to disclose.

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Authors and Affiliations

  1. Biomedical Center, 1-5-8-613 Komatsugawa, Edogawa-ku, Tokyo, 132-0034, Japan

    Eiji Kutoh & Yasuhiro Ukai

  2. Division of Diabetes and Endocrinology, Department of Internal Medicine, Gyoda General Hospital, Saitama, Japan

    Eiji Kutoh

Authors
  1. Eiji Kutoh
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  2. Yasuhiro Ukai
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Correspondence to Eiji Kutoh.

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Clinical Trail Registration: UMIN 000006860.

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Kutoh, E., Ukai, Y. Alogliptin as an initial therapy in patients with newly diagnosed, drug naïve type 2 diabetes: a randomized, control trial. Endocrine 41, 435–441 (2012). https://doi.org/10.1007/s12020-012-9596-0

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  • DOI: https://doi.org/10.1007/s12020-012-9596-0

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