India: Glyxambi

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
  • †
    Taken anytime, with or without food. Not recommended for use in patients with persistent estimated glomerular filtration rate <30 mL/min/1.73 m². Recommended dose is 5/10 mg, while the 5/25 mg is used in patients tolerating empagliflozin + linagliptin = (Glyxambi®) 5/10 mg.¹ Taken anytime, with or without food. Not recommended for use in patients with persistent estimated glomerular filtration rate <30 mL/min/1.73 m². Recommended dose is 5/10 mg, while the 5/25 mg is used in patients tolerating empagliflozin + linagliptin = (Glyxambi®) 5/10 mg.2
  • ‡
    Patient profile is hypothetical and intended to illustrate a patient profile.
  • §
    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%). 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.3
  • II
    Empagliflozin + linagliptin (Glyxambi®) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate.2,3
  • Glyxambi® is not indicated for weight loss or blood pressure reduction.2,3
  • **
    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.2,3

Abbreviations:

BP, blood pressure; CV, cardiovascular; HbA1c, glycated haemoglobin; MET, metformin; T2DM, type 2 diabetes mellitus; XR, extended release.

References:
  1. GLYXAMBI® India pack insert version. 15 May 2024.

  2. GLYXAMBI® Summary of product characteristics India; Feb 2024.

  3. DeFronzo RA, Lewin A, Patel S, Liu D, et al. Combination of Empagliflozin and Linagliptin as Second-Line Therapy in Subjects With Type 2 Diabetes Inadequately Controlled on Metformin. Diabetes Care. 2015;38(3):384–393.