A study to assess clinical profile of Indian type 2 diabetes mellitus patients treated with Teneligliptin-ASPIRE study
Keywords:Demographics, Diabetes complication, DPP4 inhibitors, Real world data, Teneligliptin, Type 2 diabetes mellitus
Background: Teneligliptin is a DPP-4 inhibitor with unique chemical structure. Efficacy and safety of Teneligliptin is well established in the patients with type 2 diabetes mellitus (T2DM) in different randomized controlled trials. However, limited real-world data is available for Teneligliptin pertaining to Indian T2DM patient profile such as demographics, duration of disease, currently prescribed anti-hyperglycemic drugs, initiation of Teneligliptin as monotherapy or as an add on therapy.
Methods: A cross-sectional, multicenter, non-interventional study was conducted to understand the demographics and clinical profile of Indian T2DM patients (n=5091) who were prescribed Teneligliptin.
Results: Majority of patients were male (65.2%) with family history of T2DM present in 43.45% of cases. Age at onset of T2DM was 51.1±11.6 years. Among the T2DM patients, 36.2% of patients were newly diagnosed and more than half of them (54.7%) were uncontrolled with current anti-hyperglycemic drugs. Mean HbA1c level among these patients was 8.09±1.3%. Mean fasting and postprandial blood glucose levels were 170.2±46.9 mg/dl and 255.3±69.3 mg/dl respectively. Teneligliptin was prescribed as monotherapy in 2165 (41.66 %) of patients while as dual, triple and quadruple therapy in 2346 (46.08%) and 551 (10.82%) and 29 (0.56%) respectively. Among the patients on current anti-hyperglycemic treatment, most commonly prescribed drugs along with Teneligliptin were metformin (43.39%) followed by glimepiride (11%) and voglibose (3.42%).
Conclusions: Teneligliptin is preferred as monotherapy and combination with metformin and sulfonylureas (mostly glimepiride) in newly diagnosed and uncontrolled T2DM patients in Indian scenario.
International Diabetes Federation (IDF) Diabetes Atlas. 8th ed. 2017. Available at: http://www.diabetesatlas.org/across-the-globe.html. Accessed on 1 October 2018.
American Diabetes Association (2018). Standards of medical care in diabete-2018. Diabetes Care, 41 (Supplement 1): S38-S73. Available at: https://diabetesed.net/wp-content/uploads/2017/12/2018-ADA-Standards-of-Care.pdf. Accessed 30 March 2019.
Sharma SK, Panneerselvam A, KP Singh, Parmar G, Gadge P, Swami OC. Teneligliptin in management of type 2 diabetes mellitus. Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy. 2016;9:251-60.
Haneda M, Kadowaki T, Ito H, Sasaki K, Hiraide S, Ishii M et al. Safety and efficacy of teneligliptin in patients with type 2 diabetes mellitus and impaired renal function: interim report from post-marketing surveillance. Diabetes Therapy. 2018;9(3):1083-97.
Ghosh 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 and Obesity: Targets and Therapy 2016;9:347-53.
Ashutosh K, Ipseeta RM, Sandeep. Assessment of prescription pattern of antidiabetic drugs in the outpatient department of a tertiary care hospital. Int J Clin Endocrinol Metab. 2017;3(1):001-7.
Venkateswaramurthy N, Shajeem MS, Sambathkumar R. Prescribing pattern of antidiabetic drugs in type-2 diabetic patients. Int J Phar Sci and Res. 2016;7(11):4550-5.
ICMR Guidelines for Management of Type 2 Diabetes 2018; Section 4: 12. Available at: https://medibulletin.com/wpcontent/uploads/2018/05/ICMR.diabetesGuidelines.2018.pdf. Accessed 30 March 2019
Davies MJ, D’Alessio DA, Fradkin J, Kernan WN, Mathieu C, Mingrone G, et al. Management of hyperglycemia in type 2 diabetes, 2018. a consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2018 Dec 1;61(12):2461-98.
Kim Y, Kang ES, Jang HC, Kim DJ, Oh T, Kim ES et al. Teneligliptin versus sitagliptin in Korean patients with type 2 diabetes inadequately controlled with metformin and glimepiride: a randomized, double‐blind, non‐inferiority trial. Diabetes, Obesity and Metabolism. 2018 Oct 26. Available at: https://www.ncbi.nlm.nih.gov/pubmed/30362280. Accessed 30 March 2019.
Haghighatpanah M, Nejad AS, Haghighatpanah M, Thunga G, Mallayasamy S. Factors that correlate with poor glycemic control in type 2 diabetes mellitus patients with complications. Osong Public Health Res Perspect. 2018;9(4):167-74.
Kayar Y, Ilhan A, Kayar NB, Unver N, Coban G, Ekinci I, et al. Relationship between the poor glycemic control and risk factors, life style and complications. Biomedical Research. 2017;28(4):1581-6.
Basu S, Garg S, Sharma N, Singh MM, Garg S. Adherence to self-care practices, glycemic status and influencing factors in diabetes patients in a tertiary care hospital in Delhi. World J Diabetes. 2018;9(5):72-9.
Litwak L, Goh SY, Hussein Z, Malek R, Prusty V, Khamseh ME. Prevalence of diabetes complications in people with type 2 diabetes mellitus and its association with baseline characteristics in the multinational A1chieve study. Diabetology and Metabolic Syndrome. 2013;5(1):57.
Joshi SR, Saboo B, Vadivale M, Dani SI, Mithal A, Kaul U et al. Prevalence of diagnosed and undiagnosed diabetes and hypertension in India-results from the screening India's twin epidemic (SITE) study. Diabetes Technology and Therapeutics. 2012;14(1):8-15.
Maniarasu K, Muthunarayanan L. Prevalence of certain chronic complications of diabetes among type 2 diabetic patients in rural population of Kancheepuram district, Tamil Nadu- A cross sectional study. Int J Med. Public Health. 2017;7(1):41-6.
Tanabe M, Motonaga R, Terawaki Y, Nomiyama T, Yanase T. Prescription of oral hypoglycemic agents for patients with type 2 diabetes mellitus: A retrospective cohort study using a Japanese hospital database. J Diabetes Investig. 2017;8:227-34.
Ko SH, Kim DJ, Park JH, Park CY, Jung CH, Kwon HS et al. Trends of antidiabetic drug use in adult type 2 diabetes in Korea in 2002-2013 nationwide population-based cohort study. Medicine. 2016;95(27):e4018.
Silverman SL. From randomized controlled trials to observational studies. Am J Med. 2009;122(2):114-20.
Sahay BK, Seshiah V. Importance of observational studies in understanding regional clinical practice: rationale and design of the A1chieve study. J Assoc Physicians India. 2013;61(1):6-8.