Sanofi has unveiled real-world data from the UK showing the efficacy of its long-acting basal insulin analogue Toujeo in treating patients with type I diabetes.
The data, presented for the first time at ENDO 2018, the Endocrine Society’s 100th Annual Meeting & Expo, in Chicago, showed that the drug is linked with statistically significant improvements in HbA1c in patients with the condition, with a mean difference of from baseline to month six of –4.4 mmol/mol.
The study also showed no change in the number of patients reporting either diabetic ketoacidosis (DKA) or severe hypoglycaemia after starting treatment with Toujeo (Gla-300).
The total number of hypoglycaemic and DKA episodes reported by patients during the six months post-initiation of Gla-300 were 31/299 (10 percent) and 7/299 (2 percent), respectively, Sanofi noted.
“Gla-300 is well-established as a cornerstone treatment for type II diabetes and its use is supported by extensive clinical data. However, this evidence is not so abundant for the treatment of type I diabetes,” noted Terence Pang, Dudley Group NHS Foundation Trust and lead study author.
“These findings provide strong real-world evidence that can provide evaluations of the effectiveness of a medicine in daily use, and augment clinical data to further help [health care professionals] make clinical decisions.”
Toujeo was approved in Europe in April 2015 after Phase III data showed that while blood sugar control was comparable to that of Sanofi’s older insulin Lantus, its safety profile was favourable, with lower incidence of confirmed hypoglycaemia day and at night in patients with type II forms of the condition.
Hypoglycaemia is one of the most frequently reported side effects in people taking insulin.