Glyxambi contains 5mg of the dipeptidyl peptidase 4 inhibitor linagliptin, plus 10mg or 25mg of the sodium-glucose co-transporter 2 (SGLT2) inhibitor empagliflozin. It can be prescribed for patients with type II diabetes inadequately controlled by metformin and/or a sulfonylurea plus linagliptin or empagliflozin, and those already being treated with linagliptin and empagliflozin as separate tablets.
In a double-blind parallel-group study, patients inadequately controlled on metformin were randomised after a 2-week placebo run-in period to add-on treatment with linagliptin/empagliflozin 5mg/10mg (n=135), linagliptin/empagliflozin 5mg/25mg (n=134), empagliflozin 10mg (n=137), empagliflozin 25mg (n=140) or linagliptin 5mg (n=128), all taken once daily.
After 24 weeks, reductions in HbA1c observed with empagliflozin/linagliptin were superior to those seen with empagliflozin or linagliptin alone as add-on to metformin. Adjusted mean changes from baseline were −13.1mmol/mol (−1.19%) with empagliflozin 25mg/linagliptin 5mg and −11.8mmol/mol (−1.08%) with empagliflozin 10mg/linagliptin 5mg, compared with −6.8mmol/mol (−0.62%) with empagliflozin 25mg, −7.2mmol/mol (−0.66%) with empagliflozin 10mg, and −7.6 mmol/mol (−0.70%) with linagliptin 5mg (p < 0.001 for all comparisons). Efficacy was maintained at 52 weeks.
Treatment with linagliptin/empagliflozin also resulted in significant improvements in fasting plasma glucose at 24 weeks compared to linagliptin or empagliflozin as individual add-on therapy to metformin.
Reductions in weight from baseline to week 24 observed with empagliflozin/linagliptin were significantly greater than those seen with linagliptin but not significantly different from those seen with either dose of empagliflozin.
The proportion of patients with adverse events over 52 weeks was similar across the treatment arms (68.6–73.0%), with no hypoglycaemic episodes requiring assistance.