A new diabetes combination therapy being developed by Sanofi has hit targets in two pivotal Phase III studies, showing a superior reduction in blood glucose compared to insulin glargine and versus lixisenatide.
The therapy is a fixed-ratio combination of the basal insulin glargine (marketed as Lantus) and GLP-1 receptor agonist lixisenatide, which has been approved in some countries as under the tradename Lyxumia.
LixiLan-O investigated the efficacy and safety of a once-daily single injection of Sanofi's combination versus treatment with either lixisenatide or insulin glargine alone over a 30 week period in 1,170 patients whose type II diabetes was not adequately controlled with metformin alone in combination with a second oral anti-diabetic agent.
After 30 weeks, the combination showed significantly greater reductions in HbA1c from baseline versus insulin glargine and lixisenatide (-1.6 percent, -1.3 percent, -0.9 percent, respectively), reaching mean HbA1c levels of 6.5 percent, 6.8 percent and 7.3 percent.
Also of note, mean body weight increased with insulin glargine (+1.1kg), but decreased with the fixed-ratio combination (-0.3 kg) and lixisenatide (-2.3kg).
The LixiLan-L trial assessed the combination versus insulin glargine over a 30 week period in 736 patients whose type II diabetes was not adequately controlled at screening on basal insulin, alone or combined with one to two oral anti-diabetic agents.
After 30 weeks, it also showed significantly greater reductions in HbA1c from baseline versus insulin glargine (-1.1 percent versus -0.6 percent), reaching mean HbA1c levels of 6.9 percent and 7.5 percent, respectively. Mean body weight increased with insulin glargine (+0.7 kg) and decreased with the titratable fixed-ratio combination (-0.7 kg).
On the safety side, the most frequent side effects reported in both studies were nausea, vomiting and diarrhoea, Sanofi noted.
The results of the LixiLan-O and LixiLan-L trials have been included in regulatory submissions in the US and Europe, with decisions expected in August (FDA) and early next year (EMA). A US decision on lixisenatide is expected in July.