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Why Glyxambi
Why Glyxambi

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Abbreviations

BP = Blood Pressure; CV = Cardiovascular; DPP-4i = Dipeptidyl peptidase-4 inhibitor; HbA1c = Hemoglobin A1c; mm = millimeter; SGLT2i = Sodium-glucose co-transporter-2 inhibitor; T2D = Type 2 Diabetes.

Footnotes

*Glyxambi® is indicated to improve glycemic control when metformin and/or sulfonylurea (SU) and one of the mono-components of GLYXAMBI do not provide adequate glycemic control, or when already being treated with the free combination of empagliflozin and linagliptin.1
†Center for Drug Evaluation and Research. Accessed from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/206073/2015Orig1s000Approv.pdf Accessed on: 2018/04/27.
‡EMA. Accessed from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004057/human_med_002000.jsp&mid=WC0b01ac058001d124.pdf Accessed on: 2018/04/27.
§Post hoc subgroup analysis from a 24-week, randomized, double-blind Phase III study (NCT01422876) in adults with type 2 diabetes inadequately controlled on metformin monotherapy. Subgroup includes patients with baseline HbA1c ≥8.5% (mean: 9.1%).2
||Taken anytime, with or without food. Not recommended for use in patients with persistent eGFR <30 mL/min/1.73 m². Recommended dose is 10/5 mg, while the 25/5 mg is used in patients tolerating empagliflozin + linagliptin = (Glyxambi®) 10/5 mg.1
¶Glyxambi® is not indicated for weight loss or blood pressure reduction.2
#Data from a 52-week, randomized, double-blind, parallel-group, Phase 3 trial (N=686) in adults with type 2 diabetes inadequately controlled on metformin. Patients received empagliflozin 25 mg/linagliptin 5 mg (n=134) as add-on to metformin. Body weight and BP changes are exploratory endpoints. Glyxambi® is not indicated for weight loss or blood pressure reduction.2
**Glyxambi® is a fixed-dose combination of empagliflozin and linagliptin. It has not been studied in a dedicated cardiovascular or renal outcomes trial.3-8
††Caution should be advised when used with insulin and secretagogues which may increase the risk of hypoglycemia.9
‡‡Hypoglycemia was defined as blood glucose ≤70 mg/dL and/or an event requiring assistance. No severe events were reported.9

References:

  1. GLYXAMBI® Saudi Arabia Local SMPC.

  2. DeFronzo RA, et al. Diabetes Care. 2015;38(3):384–393.

  3. Zinman B, et al., N Engl J Med. 2015;373(22):2117-2128.

  4. The EMPA-KIDNEY Collaborative Group,Herrington WG, Staplin N, et al. N Engl J Med. 2023;388(2):117-127.

  5. Marx N, et al., Diab Vasc Dis Res.2015;12(3):164–174.

  6. Rosenstock J, et al., JAMA. 2019;322(12):1155–1166.

  7. Rosenstock J, et al., Cardiovasc Diabetol. 2018;17(1):39.

  8. Rosenstock J, et al., JAMA. 2019;321(1):69–79.

  9. DeFronzo RA, et al., Adv Ther. 2018;35(7):1009-1022.

  10. American Diabetes Association Professional Practice Committee; 2025. Diabetes Care; 48 (Supplement_1): S181–S206.

Document Number: PC-SA-102869
Expiry Date: 08/03/2038

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