- when metformin alone is inadequate;
- in patients who are currently receiving the combination as separate tablets;
- with other hypoglycaemic agents, including insulin, when these plus metformin are inadequate.
One Synjardy tablet should normally be taken twice daily, starting at a strength that provides an empagliflozin dose of 5mg twice daily together with the patient’s current prescribed metformin dose. Tablets are available in empagliflozin/metformin strengths of 5mg/850mg, 5mg/1g, 12.5mg/850mg and 12.5mg/1g.
Renal glucose reabsorption
Empagliflozin is a reversible, competitive inhibitor of the glucose transporter SGLT2. Inhibition of SGLT2 improves glycaemic control in type II diabetes by reducing renal glucose reabsorption, which leads to excess glucose excretion in the urine. Urinary glucose excretion also triggers calorie loss, which is associated with body fat loss and body weight reduction.
Empagliflozin as add-on therapy
In 7 double-blind, placebo- or active-controlled studies (n=4704), patients with type II diabetes were treated for at least 24 weeks with empagliflozin 10mg or 25mg as an add-on to metformin, with (n=530) or without (n=2442) insulin.
Treatment with empagliflozin in combination with metformin, with or without other antidiabetic agents, led to clinically relevant improvements in HbA1c, fasting plasma glucose, body weight and blood pressure. Administration of empagliflozin 25mg resulted in a higher proportion of patients achieving an HbA1c goal of less than 7% and fewer patients needing glycaemic rescue than empagliflozin 10mg and placebo.
Empagliflozin as add-on to metformin, metformin and a sulfonylurea, or pioglitazone and metformin, resulted in significant (p<0.0001) reductions in HbA1c and body weight compared with placebo.
Side-effects comparable to single components
No additional adverse effects were identified in clinical trials with empagliflozin as an add-on to metformin compared with the side-effects of the individual drugs. The most commonly reported adverse events were hypoglycaemia in combination with insulin and/or sulfonylureas, urinary tract infections, genital infections and increased urination.