Product: Glyxambi

Pharmacologic class: Sodium-glucose co-transporter 2 inhibitor + dipeptidyl peptidase-4 inhibitor

Active ingredient(s): Empagliflozin, linagliptin; 10 mg/5mg, 25 mg/5mg; tablets

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Company: Boehringer Ingelheim and Lilly

Indication(s): 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. Limitations of use: not for treating type 1 diabetes or diabetic ketoacidosis. Not studied in patients with a history of pancreatitis.

Pharmacology: Empagliflozin, a sodium-glucose co-transporter 2 inhibitor, reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Linagliptin, a dipeptidyl peptidase-4 inhibitor, increases the concentrations of active incretin hormones, stimulating the release of insulin in a glucose-dependent manner and decreasing glucagon levels in the circulation.

Clinical trials: A double-blind, active-controlled study enrolled 686 patients with type 2 diabetes to study the efficacy and safety of empagliflozin 10 mg or 25 mg in combination with linagliptin 5 mg vs. the individual components. Patients inadequately controlled on ≥1,500mg of metformin/day entered a single-blind placebo run-in period for 2 weeks. At the end of the run-in period, patients who remained inadequately controlled and had an HbA1c between 7-10.5% were randomized to one of five active treatment arms: empagliflozin 10 mg or 25 mg, linagliptin 5 mg, or linagliptin 5 mg in combination with 10 mg or 25 mg empagliflozin as a fixed-dose combination tablet. At week 24, empagliflozin 10 mg or 25 mg used with linagliptin 5 mg provided statistically significant improvement of HbA1c (P < .0001) and fasting plasma glucose (P < .001) compared with the individual components in patients who had been inadequately controlled on metformin. Glyxambi 25 mg/5mg or 10 mg/5mg also led to a statistically significant reduction in body weight vs. linagliptin 5 mg alone (P < .0001); no statistically significant difference was seen vs. empagliflozin alone. For more clinical trial data, see full labeling.

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