Late-stage clinical data has shown Lilly's experimental diabetes drug Peglispro to be better at reducing blood sugar in patients with type II diabetes than Sanofi's Lantus - the world's most prescribed insulin.
The US drugmaker says it expects to file for approval of its basal insulin (BIL) by the first quarter of next year, after three Phase III studies showed it induced "a statistically superior reduction in HbA1c" compared with Lantus.
The clinical trials assessed the drug in different patient populations - those not previously taking insulin, those taking basal insulin with mealtime insulin, and those currently taking a basal insulin - and the primary endpoint of non-inferiority to Lantus was met across all three.
Subsequent investigation on superiority for HbA1c lowering also found that in all three clinical trials BIL came out on top.
"These results are promising," said Enrique Conterno, president, Lilly Diabetes. "Basal insulin peglispro is the first basal insulin to demonstrate consistently superior HbA1c reduction versus insulin glargine in Phase III clinical trials," and, if approved, it "could offer a differentiated profile and provide an important new treatment option for patients with diabetes," he noted.
Also of importance, the data showed that patients taking BIL experienced statistically significant lower rates of nocturnal hypoglycaemia than those taking Lantus, and patients had "comparable to statistically significant less weight gain", Lilly said.