AstraZeneca on Thursday announced interim late-stage study data suggesting that its SGLT2 inhibitor Farxiga (dapagliflozin) is a "promising" adjunct treatment to insulin to improve glycaemic control in patients with inadequately controlled type 1 diabetes. Findings from the DEPICT-1 trial were presented at the European Society for the Study of Diabetes (EASD) annual meeting and published in The Lancet Diabetes & Endocrinology.
The trial involved 778 patients aged 18 years to 75 years who had inadequately controlled type 1 diabetes, with a mean baseline HbA1c level of 8.5 percent, and who were prescribed insulin for at least 12 months before enrolment. Patients were randomised to receive either 5-mg or 10-mg of once-daily oral Farxiga, or placebo. The primary efficacy outcome was change from baseline in HbA1c after 24 weeks of treatment.
Results demonstrated that after 24 weeks of treatment, both doses of Farxiga significantly lowered HbA1c compared with placebo, with mean reductions of 0.42 percent and 0.45 percent for the 5-mg and 10-mg doses, respectively. Farxiga was also associated with significantly greater weight loss versus placebo, with mean reductions from baseline in body weight of 2.96 percent in the 5-mg dose group, and 3.72 percent in the 10-mg dose group. Further, compared to placebo, the total daily insulin dose was 8.8 percent lower after 24 weeks of treatment for patients treated with the lower Farxiga dose and 13.2 percent lower for those in the higher-dose group.
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In regards to safety, AstraZeneca said the overall adverse event profile was "in line with the known clinical profile of [Farxiga], with no imbalance in adverse events reported." The company noted that compared with placebo, occurrences of hypoglycaemia were not higher in the Farxiga treatment groups, nor was the drug associated with an increased occurrence of definite diabetic ketoacidosis. Elisabeth Björk, head of cardiovascular and metabolic diseases in AstraZeneca's global medicines development unit, said "being able to improve glucose control without increasing the risk of hypoglycaemia targets an unmet medical need in type 1 diabetes."
Farxiga is already approved for the treatment of type 2 diabetes in the US, as well as in Europe, where it is marketed under the name Forxiga. The SGLT2 inhibitor generated sales of $457 million in the first half of the year, up 22 percent on the same period of 2016, with analysts projecting nearly $2 billion in annual revenues in the next five to six years.
AstraZeneca previously marketed the drug in partnership with Bristol-Myers Squibb, but acquired the entirety of Bristol-Myers Squibb's interests in the companies' diabetes alliance in 2014.
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