Oral dapagliflozin for type-1 diabetesApril 9, 2019
EMA has recommended a new indication for dapagliflozin (Forxiga) for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D).
Dapagliflozin, a selective sodium glucose cotransporter-2 (SGLT2) inhibitor, is the first oral medicine to receive a positive recommendation from the EMA for use in T1D as an adjunct to insulin in patients, AstraZeneca said.
The DEPICT clinical programme consists of two trials, DEPICT-1 and -2, with the primary efficacy endpoint at 24 weeks and a long-term extension up to 52 weeks. Both trials demonstrated that dapagliflozin, when given as an oral adjunct to adjustable insulin in adults with inadequately-controlled T1D, showed significant reductions from baseline in HbA1c, weight and total daily insulin dose at 24 and 52 weeks, vs. placebo, at both 5mg and 10mg doses.
Dapagliflozin is also under regulatory review in the US and Japan for use as an adjunct treatment to insulin in adults with T1D.