Effect of teneligliptin vs metformin on glycemic control in Indian patients with newly-diagnosed, drug-naïve type 2 diabetes mellitus: a 12-week randomized comparative clinical study
DOI:
https://doi.org/10.18203/2349-3933.ijam20191163Keywords:
Clinical study, DPP-4 inhibitor, Efficacy, HbA1C, Metformin, Oral antidiabetic drugs, Teneligliptin, Type 2 diabetesAbstract
Background: This comparative study was done to evaluate the change from baseline in HbA1c levels with teneligliptin vs. metformin treatments at week 12 among recently diagnosed type 2 DM patients attending Medicine OPD of Dr. B. C. Roy Hospital, Haldia, West Bengal (a tertiary care teaching hospital).
Methods: In this prospective parallel group clinical study patients were divided into two groups. Group A patients were on metformin monotherapy therapy and Group B patients were on teneligliptin monotherapy. Data of 40 patients (20 patients in each group) were available for analysis in the present study. Secondary endpoints included changes from baseline FPG and 2h-PPG values at 12 weeks were evaluated. Safety and tolerability were assessed by the incidence of adverse events (AEs) throughout the study period.
Results: The mean age of patients was 50.05±12.35 years and out of the entire patient population 70% were males and 30% were females. At the end of 12 weeks or 3 months of metformin therapy, mean HbA1c, FBG, and PPG were significantly reduced by 0.52%, 16.2mg/dL, and 36.8mg/dL, respectively, and 37.75% of patients achieved the HbA1c target of <7%. At the end of 12 weeks or 3 months of teneligliptin therapy, mean HbA1c, FBG, and PPG were significantly reduced by 0.60%, 19.4mg/dL, and 49.8mg/dL, respectively (Table 2), and 40% of patients achieved the HbA1c target of <7%.
Conclusions: Teneligliptin, a DPP4 inhibitor reduced HbA1C significantly compared with monotherapy of metformin in treatment naive patients at week 12. It also reduced FBG and 2-h PPBG as compared with metformin at week 12.
References
International diabetes federation. IDF Diabetes Atlas. 7th ed. Brussels, Belgium: International Diabetes Federation, 2015. Available at: http://www.diabetesatlas.org. Accessed 17 August, 2017.
Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfo¬nylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. JAMA. 1999;281: 2005-12.
Hauber AB, Mohamed AF, Johnson FR, Falvey H. Treatment preferences and medication adherence of people with Type 2 diabetes using oral glucose-lowering agents. Diabet Med. 2009;26:416-24.
American Diabetes Association. Standards of medical care in diabetes-2016. Diabetes Care. 2016;39 (Suppl 1):S1-S106.
Garber AJ, Abrahamson MJ, Barzilay JI, Blonde L, Bloomgarden ZT, Bush MA, et al. Consensus statement by the American Association of Clinical endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm-2016 executive summary. Endocr Pract. 2016;22(1):84-113.
Ghosh S, Trivedi S, Sanyal D, Modi KD, Kharb S. Teneligliptin real-world efficacy assessment of type 2 diabetes mellitus patients in India (TREAT-INDIA study). Diabetes, Metabolic Syndrome Obesity: Targets Therapy. 2016;9:347.
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(11):1040-6.
Scott LJ. Teneligliptin: a review in type 2 diabetes. Clin Drug Investig. 2015;35(11):765-72.
ORG-IMS. From evidence. To engagement. To an entire ecosystem, 2016. Available at: https://www.imshealth.com/en/about-us/news/top-line-market-data. Accessed on 17 January 2017.
Wu W, Li Y, Chen X, Lin D, Xiang S, Shen F, Gu X. Effect of linagliptin on glycemic control in Chinese patients with newly-diagnosed, drug-Naïve type 2 diabetes mellitus: a randomized controlled trial. Medical science monitor: international medical J Exp Clin Res. 2015;21:2678.
Kutoh E, Hirate M, Ikeno Y. Teneligliptin as an initial therapy for newly diagnosed, drug naive subjects with type 2 diabetes. J Clin Med Res. 2014;6(4):287-94.
Gallwitz B, Rosenstock J, Rauch T, Bhattacharya S, Patel S, von Eynatten M, et al. 2-year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, non-inferiority trial. The Lancet. 2012 Aug 4;380(9840):475-83.
Barnett AH, Patel S, Harper R, Toorawa R, Thiemann S, von Eynatten M, et al. Linagliptin monotherapy in type 2 dia¬betes patients for whom metformin is inappropriate: an 18-week random-ized, double-blind, placebo-controlled phase III trial with a 34-week active-controlled extension. Diabetes Obes Metab. 2012;14:1145-54.
Kawamori R, Inagaki N, Araki E, Watada H, Hayashi N, Horie Y, et al. Linagliptin monotherapy provides su¬perior glycaemic control versus placebo or voglibose with comparable safe¬ty in Japanese patients with type 2 diabetes: a randomized, placebo and active comparator-controlled, double-blind study. Diabetes Obes Metab. 2012;14:348-57.
Bajaj M, Gilman R, Patel S, Kempthorne‐Rawson J, Lewis‐D'Agostino D, Woerle HJ. Linagliptin improved glycaemic control without weight gain or hypoglycaemia in patients with type 2 diabetes in-adequately controlled by a combination of metformin and pioglitazone: a 24-week randomized, double-blind study. Diabet Med. 2014;31:1505-14.
Wang W, Yang J, Yang G, Gong Y, Patel S, Zhang C, et al. Efficacy and safety of linagliptin in Asian pa¬tients with type 2 diabetes mellitus inadequately controlled by metformin: A multinational 24-week, randomized clinical trial. J Diabetes. 2016;8(2):229-37.
CTRI. E-tutorial. Available at: http://ctri.nic.in/Clinicaltrials/login.php?id=. Accessed on 14 January 2017.
Doupis J, Veves A. DPP4 inhibitors: a new approach in diabetes treatment. Adv Ther. 2008;25:627-43.
Kadowaki T, Kondo K. Efficacy, safety and dose-response relationship of teneligliptin, a dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2013;15:810-8.
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;16:418-25.
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;4:576-84.
Kadowaki T, Marubayashi F, Yokota S, Katoh M, Iijima H. 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;16:971-81.
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;14:1040-6.
Monami M, Lamanna C, Desideri CM, Mannucci E. DPP-4 inhibitors and lipids: systematic review and meta-analysis. Adv Ther. 2012;29:14-25.
Sone H, Tanaka S, Tanaka S, Iimuro S, Oida K, Yamasaki Y, et al. Japan Diabetes Complications Study Group. Serum level of triglycerides is a potent risk factor comparable to LDL cholesterol for coronary heart disease in Japanese patients with type 2 diabetes: subanalysis of the Japan Diabetes Complications Study (JDCS). J Clin Endocrinol Metab. 2011;96:3448-56.
Hsieh J, Longuet C, Baker CL, Qin B, Federico LM, Drucker DJ, Adeli K. The glucagon-like peptide 1 receptor is essential for postprandial lipoprotein synthesis and secretion in hamsters and mice. Diabetologia. 2010;53:552-61.
Matikainen N, Mänttäri S, Schweizer A, et al. Vildagliptin therapy reduces postprandial intestinal triglyceride-rich lipoprotein particles in patients with type 2 diabetes. Diabetologia. 2006;49:2049-57.
Tremblay AJ, Lamarche B, Deacon CF, Weisnagel SJ, Couture P. Effect of sitagliptin therapy on postprandial lipoprotein levels in patients with type 2 diabetes. Diabetes Obes Metab. 2011;13:366-73.
Wojdemann M, Wettergren A, Sternby B, Holst JJ, Larsen S, Rehfeld JF, Olsen O. Inhibition of human gastric lipase secretion by glucagon-like peptide-1. Dig Dis Sci. 1998;43:799-805.
Qin X, Shen H, Liu M, Yang Q, Zheng S, Sabo M, et al. GLP-1 reduces intestinal lymph flow, triglyceride absorption, and apolipoprotein production in rats. Am J Physiol Gastrointest Liver Physiol. 2005;288:G943-G949.
Mahler R, Statford WS, Tarrant ME, Ashmore J. The effect of insulin on lipolysis. Diabetes. 1964;13:297-302.
Goldstein BJ, Feinglos MN, Lunceford JK, Johnson J, Williams Herman DE. Sitagliptin 036 Study Group. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes. Diabetes Care. 2007;30:1979-87.
Scheen AJ. A review of gliptins in 2011. Expert Opin Pharmacother. 2012;13:81-99.
