![img](/in/products/glyxambi/sites/default/files/2023-04/bg%402x.jpg)
Powerful Efficacy.
Ensured Safety.
Convenient Dosing.
Differentiation v/s other FDCs
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Glyxambi® is not indicated for treatment of HF or CKD. * Glyxambi® is not indicated for weight reduction or BP reduction. ## CV death reduction. §§ Proven in the EM PA-REG OUTCOME® trial. ‡‡ Proven in the CARMELINA® trial.
†† Proven in the TECOS trial. # Exploratory endpoint in the EM PA-REG OUTCOME® trial. ^ Prespecified microvascular endpoint in the CARMELINA® trial. α Immediate release tablet. β New or worsening nephropathy, a composite of: progression to macroalbuminuria, doubling of serum creatinine, initiation of RRT, or renal death.
EMPA: Empagliflozin. LINA: Linagliptin. FDC: Fixed-dose combination. MET: Metformin. SITA: Sitagliptin. BP: Blood pressure. CRM: Cardio-renal-metabolic. VILDA: Vildagliptin. CV: Cardiovascular. HF: Heart failure. CVOT: Cardiovascular outcome trial. hHF: Hospitalisation due to heart failure. RRR: Relative risk reduction. T2DM: Type 2 diabetes mellitus. DPP4i: Dipeptidyl peptidase-4 inhibitor. RRT: Renal replacement therapy. CKD: Chronic kidney disease.
References:
Thrasher J. Am J Med. 2017;130(6S):S4-S17.
DeFronzo RA, et al. Diabetes Care. 2015;38(3):384-393. (Based on subgroup analysis of patients with HbA1c >8.5°/o at baseline).
Zinman B, et al. N Engl J Med. 2015;373(22):2117-2128.
Rosenstock J, et al. JAMA. 2019;322(12):1155-66.
Rosenstock J, et al. JAMA. 2019;321(1):69-79.
Wanner C, et al. N Engl J Med. 2016;375:323-334.
Green JB, et al. N Engl J Med. 2015;373:232-42.
Cornel JH, et al. Diabetes Care. 2016;39:2304-2310.
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Glyxambi® is not indicated for treatment of HF or CKD. * Potential albuminuria benefits with Linagliptin as evidenced from CARMELINA® trial. # Clinical benefit/safety seen with innovator SGLT2i/DPP4i in CVOTs may not be replicable to its generic versions.
EMPA: Empagliflozin. LINA: Linagliptin. DAPA: Dapagliflozin. VILDA: Vildagliptin. SITA: Sitagliptin. MET: Metformin. CV: Cardiovascular. JP-MACE: 3-point major adverse cardiovascular events. CVOT: Cardiovascular outcome trial. FDC: Fixed-dose combination.
CRM: Cardio-renal-metabolic. HbA le: Glycated haemoglobin. eGFR: Estimated glomerular filtration rate. CKD: Chronic kidney disease.
HF: Heart failure. SGL2Ti: Sodium-glucose co-transporter-2 inhibitor. DPP4i: Dipeptidyl peptidase-4 inhibitor.
References:
- Lewin A, et al. Diabetes Care. 2015;38(3):394-402.
- DeFronzo RA, et al. Diabetes Care. 2015;38(3):384-393.
- Zinman B, et al. N Engl J Med. 2015;373:2117.
- Rosenstock J, et al. JAMA. 2019;321(1):69-79.
- Kuchay MS, et al. Diabetes Care. 2018;41(8):1801-1808.
- Inagaki N, et al. J Diabetes Complications. 2016;30(8):1622-1630.
- GLYXAMBI® India pack insert version: 12 Jul 2021.
- Wanner C, et al. N Engl J Med. 2016;375:323.
- Kovil R, et al. JAPI. 2020. Accessed from: https://www.japi.org/x2649454/single-pill-combination-of-empagliflozin-and-linagliptin-in-realworld-indian-type-2-diabetes-patient-grid. Accessed on Dec 7, 2020.
- Joshi S, Endocr Pract. 2020. Accessed from: https://www.endocrinepractice.org/article/S1530-891X(20)39836-0/pdf. Accessed on Jan 19, 2020.
- Bhattacharya S. Abstract #1003971: Efficacy and Safety of Empagliflozin and Linagliptin Combination in Non-hospitalized COVID-19 Positive Patients with T2DM in Real World Setting: A Single Center Retrospective Study. Endocr Pract. 2021;27(6):S57.
- Gupta A, et al. J Assoc Physicians India. 2021;69(7):11-12.
- Bhattacharyya S, et al. Int J Diab. 2020;14-18.
- Supratik Bhattacharyya, Aditya Bikram Mishra, Maneesha Khalse. Clinical Effectiveness Of Fixed Dose Combination Of Empagliflozin And Linagliptin (empa/lina) In Patients With Type 2 Diabetes Mellitus Unwilling To Continue Basal Insulin Therapy: A Real-world Experience In Indian Setting, IJAR - Indian Journal of Applied Research(IJAR), IJAR I World Wide Journals/ Accessed on Aug. 20, 2021.
- Bhattacharyya S. Diabetes. 2021;70(Supplement 1).
- https://ctri.nic.in/Clinicaltrials/pdf _generate.php?trialid=55328&EncH id =&modid=&compid=%27, 0/o2755328det0/o27/ Accessed on Aug 20, 2021.
- Wiviott S, et al. N Engl J Med. 2019;380(4):347-357.
- Green JB, et al. N Engl J Med. 2015;373:232-42.
- Merck. Januvia® (sitagliptin) summary of product characteristics. Feb 2021.
- Gluxit-S® India pack insert version: June 2022.
- Mosenzon 0, et al. Lancet Diabetes Endocrinol. 2019;7(8):606-17.
- Novartis Galvus® (vildagliptin) summary of product characteristics. Nov 2020.
![16-9-copy-3@2x](/in/products/glyxambi/sites/default/files/2023-04/16-9-copy-3%402x_4.png)
![16-9-copy-3@2x](/in/products/glyxambi/sites/default/files/2023-04/16-9-copy-3%402x_4.png)
Glyxambi® is not indicated for treatment of HF or CKD. * Potential albuminuria benefits with Linagliptin X as evidenced in the CARMELINA® trial. # Clinical benefits/safety seen with innovator SGLT 2i/DPP4i in CVOTs may not be replicable to its generic versions.
FDC: Fixed-dose combination. MET: Metformin. CVOT: Cardiovascular outcome trial. OD: Once-daily. LINA: Linagliptin. CV: Cardiovascular. 3P-MACE: 3-point major adverse cardiovascular events. hHF: Hospitalisation due to heart failure. BID: Twice-daily. EMPA: Empagliflozin. REMO: Remogliflozin. VILDA: Vildagliptin. LV: Left ventricular. HbA1c: Glycated haemoglobin. CRM: Cardio-renal-metabolic. CKD: Chronic kidney disease. HF: Heart failure. SGL2Ti: Sodium-glucose co-transporter-2 inhibitor. DPP4i: Dipeptidyl peptidase-4 inhibitor.
References:
Lewin A, et al. Diabetes Care. 2015;38(3):394-402.
DeFronzo RA, et al. Diabetes Care. 2015;38(3):384-393. (Based on subgroup analysis of patients with HbAlc ;?8.5°/o at baseline).
Kiran Ket al. J Assoc Physicians India. 2022 Apr;70(4):11-12
Zinman B, et al. N Engl J Med. 2015;373(22):2117-2128.
Rosenstock J, et al. JAMA. 2019;321(1):69-79.
McMurray JJ, et al. JACC Heart Fail. 2018;6(1):8-17.
Cosentino F, et al. Eur Heart J. 2020;41(2):255-323.
Glyxambi® Pl Boehringer lngelheim Pvt. Ltd. Version July 2021.
Remo® -V Pl Glenmark Pharmaceuticals Ltd. 2020.