FORXIGA® (dapagliflozin)

FORXIGA® is a highly selective SGLT2 inhibitor for type 2 diabetes mellitus, with 4-year safety and efficacy data, that removes glucose and its associated calories via the kidney.1

FORXIGA®: Safety and tolerability

Results from an extensive clinical trial programme1

Hypoglycaemia

FORXIGA® demonstrated a lower incidence of hypoglycaemia vs. a sulphonylurea when added to metformin42

FORXIGA® demonstrated a lower incidence of hypoglycaemia vs. a sulphonylurea when added to metformin[2]
FORXIGA® demonstrated a lower incidence of hypoglycaemia vs. a sulphonylurea when added to metformin[2]

*Major hypoglycaemia was defined as a symptomatic episode requiring external assistance due to severely impaired consciousness or behaviour, with capillary or plasma glucose levels of 54 mg/dl (3.0 mmol/L) and recovery after glucose or glucagon administration.42

  • Minor hypoglycaemia was defined as a symptomatic episode with capillary or plasma glucose levels of 63 mg/dl (3.5 mmol/L), irrespective of the need for external assistance, or an asymptomatic episode with capillary or plasma glucose levels of 63 mg/dL (3.5 mmol/L) that did not qualify as a major episode
  • Other hypoglycaemia was defined as an episode with symptoms suggestive of hypoglycaemia but without measurement confirmation.

The frequency of hypoglycaemia depended on the type of background therapy used in each study.1

  • For studies of FORXIGA® in monotherapy, as add-on to metformin or as add-on to sitagliptin (with or without metformin), the frequency of minor episodes of hypoglycaemia was similar (<5%) between treatment groups, including placebo up to 102 weeks of treatment. Across all studies, major events of hypoglycaemia were uncommon and comparable between the groups treated with dapagliflozin or placebo. Studies with add-on sulphonylurea and add-on insulin therapies had higher rates of hypoglycaemia
  • In an add-on to glimepiride study, minor episodes of hypoglycaemia were reported more frequently in the group-treated with FORXIGA® 10 mg plus glimepiride (6.0%) than in the placebo plus glimepiride group (2.1%)
  • In an add-on to insulin study, minor episodes were reported more frequently in the group treated with FORXIGA® 10 mg plus insulin (40.3%) than in the placebo plus insulin group (34.0%)
  • In an add-on to metformin and a sulphonylurea study, up to 24 weeks, no episodes of major hypoglycaemia were reported. Minor episodes of hypoglycaemia were reported in 12.8% of subjects who received dapagliflozin 10 mg plus metformin and a sulphonylurea and in 3.7% of subjects who received placebo plus metformin and a sulphonylurea.

Reactions related to volume depletion (including, reports of dehydration, hypovolaemia or hypotension) were reported in 1.1% and 0.7% of subjects who received dapagliflozin 10 mg and placebo, respectively; serious reactions occurred in <0.2% of subjects balanced between FORXIGA® 10 mg and placebo.1

In a study comparing FORXIGA® + metformin vs. sulphonylurea + metformin, the FORXIGA® arm showed a significantly reduced incidence of hypoglycaemia compared to glipizide (3.5% vs. 40.8%, p < 0.0001) at 52 weeks.42
There were no major hypoglycaemic events on the FORXIGA® + metformin arm, compared to 3 episodes on the sulphonylurea + metformin arm.42