Metformin, Empagliflozin With Sitagliptin vs Linagliptin in Type 2 Diabetes

Summary

This clinical trial aims to evaluate and compare the comparative efficacy and safety of Metformin-Empagliflozin-Sitagliptin vs. Metformin-Empagliflozin-Linagliptin in newly diagnosed Type 2 Diabetes Mellitus patients. The study will involve 110 participants, aged 30-55, enrolled at the National Medical Centre, Karachi, Pakistan. The study involves two groups, subjects will receive the following treatments: Group A will receive Tab Metformin 1000mg + Tab Empagliflozin 12.5mg (FDC) + Tab Sitagliptin 50mg, whereas Group B will receive Tab Metformin 1000mg + Tab Empagliflozin 12.5mg + Tab Linagliptin 2.5mg (FDC) per orally, once daily, for 90 days. Safety and efficacy will be assessed through anthropometric measurements and lab investigations at baseline, 6 weeks, and 12 weeks, with weekly monitoring of blood sugar levels. The total duration of the study will be 6 months, with a 3-month individual treatment period.

Timeline

Start

2026-01-01

Primary completion

2026-03-30

Completion

2026-06-30

Publications

• Background Ghasemi P, Jafari M, Maskouni SJ, Hosseini SA, Amiri R, Hejazi J, Chambari M, Tavasolian R, Rahimlou M. Impact of very low carbohydrate ketogenic diets on cardiovascular risk factors among patients with type 2 diabetes; GRADE-assessed systematic review and meta-analysis of clinical trials. Nutr Metab (Lond). 2024 Jul 19;21(1):50. doi: 10.1186/s12986-024-00824-w.
• Background Khan F, Hussain T, Chaudhry TZ, Payal F, Shehryar A, Rehman A, Ramadhan A, Hayat MT, Dabas MM, Khan M. Comparing the Efficacy and Long-Term Outcomes of Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors, Dipeptidyl Peptidase-4 (DPP-4) Inhibitors, Metformin, and Insulin in the Management of Type 2 Diabetes Mellitus. Cureus. 2024 Nov 25;16(11):e74400. doi: 10.7759/cureus.74400. eCollection 2024 Nov.
• Background Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Kelly T, Irvine K, Peters C, Zhyzhneuskaya S, Hollingsworth KG, Adamson AJ, Sniehotta FF, Mathers JC, McIlvenna Y, Welsh P, McConnachie A, McIntosh A, Sattar N, Taylor R. 5-year follow-up of the randomised Diabetes Remission Clinical Trial (DiRECT) of continued support for weight loss maintenance in the UK: an extension study. Lancet Diabetes Endocrinol. 2024 Apr;12(4):233-246. doi: 10.1016/S2213-8587(23)00385-6. Epub 2024 Feb 26.
• Background Ahmed AM. History of diabetes mellitus. Saudi Med J. 2002 Apr;23(4):373-8.
• Background Wilding JPH, Evans M, Fernando K, Gorriz JL, Cebrian A, Diggle J, Hicks D, James J, Newland-Jones P, Ali A, Bain S, Da Porto A, Patel D, Viljoen A, Wheeler DC, Del Prato S. The Place and Value of Sodium-Glucose Cotransporter 2 Inhibitors in the Evolving Treatment Paradigm for Type 2 Diabetes Mellitus: A Narrative Review. Diabetes Ther. 2022 May;13(5):847-872. doi: 10.1007/s13300-022-01228-w. Epub 2022 Mar 20.
• Background Zhang X, Tong WK, Xia Q, Tang Z. The impact of dipeptidyl peptidase 4 inhibitors on health-related quality of life in patients with type 2 diabetes mellitus: a systematic review and meta-analysis. Qual Life Res. 2024 Dec;33(12):3175-3188. doi: 10.1007/s11136-024-03753-6. Epub 2024 Aug 3.
• Background Katsimardou A, Theofilis P, Vordoni A, Doumas M, Kalaitzidis RG. The Effects of SGLT2 Inhibitors on Blood Pressure and Other Cardiometabolic Risk Factors. Int J Mol Sci. 2024 Nov 18;25(22):12384. doi: 10.3390/ijms252212384.
• Background Lopez-Candales A, Monte S, Sawalha K, Norgard NB. Time to revisit the true role of metformin in type 2 diabetes mellitus. Postgrad Med. 2023 Aug;135(6):539-542. doi: 10.1080/00325481.2023.2224036. Epub 2023 Jun 14. No abstract available.
• Background Zhang L, Zhang Y, Shen S, Wang X, Dong L, Li Q, Ren W, Li Y, Bai J, Gong Q, Kuang H, Qi L, Lu Q, Cheng W, Liu Y, Yan S, Wu D, Fang H, Hou F, Wang Y, Yang Z, Lian X, Du J, Sun N, Ji L, Li G; China Diabetes Prevention Program Study Group. Safety and effectiveness of metformin plus lifestyle intervention compared with lifestyle intervention alone in preventing progression to diabetes in a Chinese population with impaired glucose regulation: a multicentre, open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2023 Aug;11(8):567-577. doi: 10.1016/S2213-8587(23)00132-8. Epub 2023 Jul 3.
• Background Lu X, Xie Q, Pan X, Zhang R, Zhang X, Peng G, Zhang Y, Shen S, Tong N. Type 2 diabetes mellitus in adults: pathogenesis, prevention and therapy. Signal Transduct Target Ther. 2024 Oct 2;9(1):262. doi: 10.1038/s41392-024-01951-9.

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