2,925
Views
21
CrossRef citations to date
0
Altmetric
Original Research

Efficacy and safety of teneligliptin add-on to insulin monotherapy in Japanese patients with type 2 diabetes mellitus: a 16-week, randomized, double-blind, placebo-controlled trial with an open-label period

, , , , , & show all
Pages 1291-1300 | Received 13 Jun 2017, Accepted 20 Jul 2017, Published online: 10 Aug 2017

References

  • IDF Diabetes Atlas 2015-7th Edition. International Diabetes Federation; 2015. Available at: http://www.diabetesatlas.org/.
  • Yabe D , Seino Y , Fukushima M , et al. β cell dysfunction versus insulin resistance in the pathogenesis of type 2 diabetes in East Asians. Curr Diab Rep. 2015;15(6):602.
  • Ko SH , Kim DJ , Park JH , et al. Task force team for diabetes fact sheet of the Korean diabetes association. Trends of antidiabetic drug use in adult type 2 diabetes in Korea in 2002-2013: nationwide population-based cohort study. Medicine (Baltimore). 2016;95(27):e4018.
  • Kohro T , Yamazaki T , Sato H , et al. Trends in antidiabetic prescription patterns in Japan from 2005 to 2011. Int Heart J. 2013;54(2):93–97.
  • ORIGIN Trial Investigators, Gerstein HC , Bosch J , Dagenais GR , et al. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med. 2012; 367(4):319–328.
  • Ryan EA , Imes S , Wallace C. Short-term intensive insulin therapy in newly diagnosed type 2 diabetes. Diabetes Care. 2004;27(5):1028–1032.
  • Wajchenberg BL. Beta-cell failure in diabetes and preservation by clinical treatment. Endocr Rev. 2007;28(2):187–218.
  • Li Y , Xu W , Liao Z , et al. Induction of long-term glycemic control in newly diagnosed type 2 diabetic patients is associated with improvement of beta-cell function. Diabetes Care. 2004;27(11):2597–2602.
  • Weng J , Li Y , Xu W , et al. Effect of intensive insulin therapy on beta-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes: a multicenter randomised parallel-group trial. Lancet. 2008;371(9626):1753–1760.
  • Hong ES , Khang AR , Yoon JW , et al. Comparison between sitagliptin as add-on therapy to insulin and insulin dose-increase therapy in uncontrolled Korean type 2 diabetes: CSI study. Diabetes Obes Metab. 2012;14(9):795–802.
  • Rehman MB , Tudrej BV , Soustre J , et al. Efficacy and safety of DPP-4 inhibitors in patients with type 2 diabetes: meta-analysis of placebo-controlled randomized clinical trials. Diabetes Metab. 2017;43(1):48–58.
  • Seino Y , Kuwata H , Yabe D. Incretin-based drugs for type 2 diabetes: focus on East Asian perspectives. J Diabetes Investig. 2016;7(Suppl 1):102–109.
  • Hinnen D . Dipeptidyl peptidase-4 inhibitors in diverse patient populations with type 2 Diabetes. Diabetes Educ. 2015;41(1 Suppl):19S–31S.
  • de Wit HM , Te Groen M , Rovers MM , et al. The placebo response of injectable GLP-1 receptor agonists vs. oral DPP-4 inhibitors and SGLT-2 inhibitors: a systematic review and meta-analysis. Br J Clin Pharmacol. 2016;82(1):301–314.
  • Karagiannis T , Paschos P , Paletas K , et al. Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis. BMJ. 2012;344:e1369.
  • Aroda VR , Henry RR , Han J , et al. Efficacy of GLP-1 receptor agonists and DPP-4 inhibitors: meta-analysis and systematic review. Clin Ther. 2012;34(6):1247–1258.e22.
  • Eto T , Inoue S , Kadowaki T . Effects of once-daily teneligliptin on 24-h blood glucose control and safety in Japanese patients with type 2 diabetes mellitus: a 4-week, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2012;14:1040–1046.
  • Tanaka S , Suzuki K , Aoki C , et al. Add-on treatment with teneligliptin ameliorates glucose fluctuations and improves glycemic control index in Japanese patients with type 2 diabetes on insulin therapy. Diabetes Technol Ther. 2014;16(12):840–845.
  • Kadowaki T , Kondo K . Efficacy and safety of teneligliptin in combination with pioglitazone in Japanese patients with type 2 diabetes mellitus. J Diabetes Investig. 2013;4(6):576–584.
  • Kadowaki T , Kondo K . Efficacy and safety of teneligliptin added to glimepiride in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study with an open-label, long-term extension. Diabetes Obes Metab. 2014;16(5):418–425.
  • Fa.Kyorin.co.jp . The treatment guide for diabetes 2014-2015. Chapter 6. Pharmacotherapy, B Types of Insulin Preparations; p 33–34. Japan Diabetes Society. Japan; [cited 2017 Jul 10 ]. Available from http://www.fa.kyorin.co.jp/jds/uploads/Treatment_Guide_for_Diabetes_2014-2015.pdf
  • Kadowaki T , Marubayashi F , Yokota S , et al. Safety and efficacy of teneligliptin in Japanese patients with type 2 diabetes mellitus: a pooled analysis of two Phase III clinical studies. Expert Opin Pharmacother. 2015;16(7):971–981.
  • Kim MK , Rhee EJ , Han KA , et al. Efficacy and safety of teneligliptin, a dipeptidyl peptidase-4 inhibitor, combined with metformin in Korean patients with type 2 diabetes mellitus: a 16-week, randomized, double-blind, placebo-controlled phase III trial. Diabetes Obes Metab. 2015;17(3):309–312.
  • Otsuka Y , Yamaguchi S , Furukawa A , et al. Addition of sitagliptin or metformin to insulin monotherapy improves blood glucose control via different effects on insulin and glucagon secretion in hyperglycemic Japanese patients with type 2 diabetes. Endocr J. 2015;62(2):133–143.
  • Esposito K , Cozzolino D , Bellastella G , et al. Dipeptidyl peptidase-4 inhibitors and HbA1c target of <7% in type 2 diabetes: meta-analysis of randomized controlled trials. Diabetes Obes Metab. 2011;13(7):594–603.
  • Kim YG , Min SH , Hahn S , et al. Efficacy and safety of the addition of a dipeptidyl peptidase-4 inhibitor to insulin therapy in patients with type 2 diabetes: a systematic review and meta-analysis. Diabetes Res Clin Pract. 2016;116:86–95.
  • Chen C , Yu Q , Zhang S , et al. Assessing the efficacy and safety of combined DPP-4 inhibitor and insulin treatment in patients with type 2 diabetes: a meta-analysis. Int J Clin Exp Pathol. 2015;8(11):14141–14150.
  • Min SH , Yoon JH , Hahn S , et al. Comparison between SGLT2 inhibitors and DPP4 inhibitors added to insulin therapy in type 2 diabetes: a systematic review with indirect comparison meta-analysis. Diabetes Metab Res Rev. 2016 May 7 Epub ahead of print. DOI:10.1002/dmrr.2818.
  • Mitsubishi Tanabe Pharma Corp . Tenelia® tablets 20 mg Package Insert 2012.
  • Amiel SA , Dixon T , Mann R , et al. Hypoglycaemia in type 2 diabetes. Diabet Med. 2008;25(3):245–254.
  • Ahrén B . Avoiding hypoglycemia: a key to success for glucose-lowering therapy in type 2 diabetes. Vasc Health Risk Manag. 2013;9:155–163.
  • Matsuba I , Sawa T , Kawata T , et al. Cross-national variation in glycemic control and diabetes-related distress among east asian patients using insulin: results from the MOSAIc study. Diabetes Ther. 2016;7(2):349–360.
  • Polinski JM , Kim SC , Jiang D , et al. Geographic patterns in patient demographics and insulin use in 18 countries, a global perspective from the multinational observational study assessing insulin use: understanding the challenges associated with progression of therapy (MOSAIc). BMC Endocr Disord. 2015;15:46.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.