Micro Labs Launches Sitanorm-E, Sitagliptin-Empagliflozin FDC for Uncontrolled Type 2 Diabetes in India
Micro Labs has announced the launch of Sitanorm-E, a fixed-dose combination (FDC) of Sitagliptin and Empagliflozin. The combination is formulated to address the growing challenge of uncontrolled type 2 diabetes mellitus (T2DM), particularly in patients not achieving adequate glycemic control with metformin alone.
Sitanorm-E tablets, a fixed-dose combination of Sitagliptin and Empagliflozin, has received DCGI approval for the treatment of type 2 diabetes mellitus in patients who are inadequately controlled with metformin alone.
It is available in two strengths—Sitanorm E 10 (Sitagliptin 100 mg + Empagliflozin 10 mg) and Sitanorm E 25 (Sitagliptin 100 mg + Empagliflozin 25 mg)—priced at ₹180 and ₹198 for a strip of 10 tablets.
The launch comes at a time when global treatment guidelines are evolving to prioritize outcomes beyond glycemic control. The American Diabetes Association (ADA)1 and the European Association for the Study of Diabetes (EASD) recommend the use of SGLT2 inhibitors and DPP4 inhibitors, either as monotherapy or in combination, for T2DM patients, especially those with established cardiovascular disease (CVD), chronic kidney disease (CKD), or at high risk of such complications.
Empagliflozin and Sitagliptin: EMpowered to Protect Beyond Glycemic control
The two molecules in Sitanorm-E have well-established clinical benefits:
Empagliflozin a potent, highly selective, sodium glucose cotransporter-2 (SGLT2) inhibitor, is an effective and generally well-tolerated anti-hyperglycaemic agent approved for the treatment of adults with type 2 diabetes (T2D). It has also shown cardio-renal protective effects in multiple large-scale landmark trials such as EMPA-REG OUTCOME, EMPEROR-Reduced/Preserved, and EMPA-KIDNEY. These studies demonstrated reduced risk of cardiovascular death, hospitalization for heart failure, and progression of kidney disease2. Beyond lowering glucose, empagliflozin exerts a favourable effect on a number of beyond-glycaemic outcomes, including reductions in bodyweight and blood pressure.
Sitagliptin, a DPP4 inhibitor, approved in more than 130 countries across the globe and is widely prescribed India and has shown good glycemic efficacy, low hypoglycemia with a neutral effect on cardiovascular risk, as reported in the TECOS trial3.
Addressing India’s Diabetes Burden
India is facing a massive diabetes crisis. With an estimated 74.9 million adults (aged 20–79 years) currently living with diabetes, the country ranks second globally, after China. According to the International Diabetes Federation (IDF)4, one in every seven diabetic adults worldwide is Indian. The condition impacts nearly one in three households, straining both personal finances and the national healthcare system5.
Indian studies revealed that over 50% of diabetes patients have poor glycemic control (HbA1c >8%) and coexisting issues like hypertension and dyslipidemia. Despite treatment, 72.7% still had HbA1c above 7%. Infrequent monitoring further worsens outcomes, increasing the risk of serious vascular complications and higher mortality6.
Uncontrolled diabetes can lead to serious complications such as heart disease, kidney failure, blindness, and amputations. Hence, timely and effective management is crucial.
Speaking to Medical Dialogues, Mr. Satish G. Mansukhani, Sr. Vice President – Sales & Marketing at 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.”
Micro Labs is one of India's leading pharmaceutical companies with a strong presence in cardiology, diabetology, neurology, and ophthalmology. The company, headquartered in Bengaluru, Karnataka, is known for its flagship brand Dolo 650, and continues to invest in research-backed, patient-centric therapies across various specialties.
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) International Diabetes Federation. IDF Diabetes Atlas, 11th edn. Brussels, Belgium: 2025. Available at: https://diabetesatlas.org
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.
6) Muralidharan, Shrikanth. Diabetes and current Indian scenario: A narrative review. Journal of Diabetology 15(1):p 12-17, January-March 2024. | DOI: 10.4103/jod.jod_93_23
