Micro Labs Launches Sitanorm E: Sitagliptin + Empagliflozin FDC for diabetes patients in India

Micro Labs has announced the launch of Sitanorm-E, a fixed-dose combination (FDC) of Sitagliptin and Empagliflozin for the management of uncontrolled type 2 diabetes mellitus (T2DM).

Sitanorm-E is the fixed-dose combination of Sitagliptin and Empagliflozin which is approved by DCGI for the management of type 2 diabetes mellitus in patients inadequately controlled on metformin monotherapy. Sitanorm-E tablets are available in two strengths: Sitanorm-E 10 mg and Sitanorm-E 25 mg. Sitanorm-E 10 mg is priced at ₹180, and Sitanorm-E 25 mg priced at ₹198 per strip of 10 tablets.

Recent global guidelines, including those from the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)¹, recommend consideration of the combination of SGLT2 inhibitors and DPP4 inhibitors for patients with type 2 diabetes, particularly those at high risk of cardiovascular and renal complications.

Empagliflozin, supported by landmark trials like EMPA-REG, EMPA-KIDNEY, and EMPEROR, has demonstrated cardiovascular and renal protection². Sitagliptin, widely used in India, has shown effective glycemic control without increasing cardiovascular risk, as confirmed by the TECOS trial³. Studies also showed that fixed-dose combination has shown reductions in HbA1c, along with added benefits of weight loss, blood pressure control, and a favorable safety profile in both drug-naïve and treatment-experienced T2DM patients⁴.

Speaking to Medical dialogues Mr. Satish G Mansukhani, Sr. Vice President Sales & Marketing, Micro labs said “Sitanorm -E provides an excellent opportunity for patients with T2DM with co-morbid conditions like CKD & CVD. This therapy also offers end-organ protection in uncontrolled type 2 diabetes mellitus.”

India currently ranked second globally in diabetes burden, with an estimated 74.9 million adults (aged 20–79) living with diabetes. According to the International Diabetes Federation (IDF), one in every seven diabetic adults worldwide lives in India, and nearly one in three Indian households is affected by the disease⁵.

References:

1) Dennis JM, Young KG, McGovern AP, Mateen BA, Vollmer SJ, Simpson MD, Henley WE, Holman RR, Sattar N, Pearson ER, Hattersley AT, Jones AG, Shields BM; MASTERMIND consortium. Development of a treatment selection algorithm for SGLT2 and DPP-4 inhibitor therapies in people with type 2 diabetes: a retrospective cohort study. Lancet Digit Health. 2022 Dec;4(12):e873-e883. doi: 10.1016/S2589-7500(22)00174-1. PMID: 36427949.

2) Colbert GB, Madariaga HM, Gaddy A, Elrggal ME, Lerma EV. Empagliflozin in Adults with Chronic Kidney Disease (CKD): Current Evidence and Place in Therapy. Ther Clin Risk Manag. 2023 Feb 2;19:133-142. doi: 10.2147/TCRM.S398163. PMID: 36756278; PMCID: PMC9901477.

3) Green JB, Bethel MA, Armstrong PW, Buse JB, Engel SS, Garg J, Josse R, Kaufman KD, Koglin J, Korn S, Lachin JM, McGuire DK, Pencina MJ, Standl E, Stein PP, Suryawanshi S, Van de Werf F, Peterson ED, Holman RR; TECOS Study Group. Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2015 Jul 16;373(3):232-42. doi: 10.1056/NEJMoa1501352. Epub 2015 Jun 8. Erratum in: N Engl J Med. 2015 Aug 6;373(6):586. doi: 10.1056/NEJMx150029. PMID: 26052984.

4) Park YH, Sohn M, Lee SY, Lim S. Two-Year Therapeutic Efficacy and Safety of Initial Triple Combination of Metformin, Sitagliptin, and Empagliflozin in Drug-Naïve Type 2 Diabetes Mellitus Patients. Diabetes Metab J. 2024 Mar;48(2):253-264. doi: 10.4093/dmj.2023.0128. Epub 2024 Jan 26. PMID: 38273791; PMCID: PMC10995484.

5) Pradeepa R, Mohan V. Epidemiology of type 2 diabetes in India. Indian J Ophthalmol. 2021 Nov;69(11):2932-2938. doi: 10.4103/ijo.IJO_1627_21. PMID: 34708726; PMCID: PMC8725109.