Sanofi has released results of a 24-week Phase IIIb clinical trial showing that Lyxumia (lixisenatide) met the primary endpoint of non-inferiority in blood sugar lowering (HbA1c) when administered to patients either before breakfast or the main meal.
The results showed that lixisenatide can effectively lower blood sugar at either time of administration as well as achieved a comparable reduction in body weight, regardless of the meal before which the drug was administered.
In addition, gastrointestinal tolerability was comparable regardless of time of administration and no cases of severe hypoglycemia were reported in either arm.
Lund University professor of Faculty of Medicine Bo Ahren said helping patients reach their HbA1c goal is the main objective of type 2 diabetes treatment.
"Flexibility in timing of administration is also an important attribute, especially for injectable diabetes therapies," Ahren said.
"This study shows that once-daily lixisenatide meets these criteria, which is significant for an agent that is prescribed for use in combination with existing treatment regimens."
About 451 patients with type 2 diabetes, uncontrolled on metformin alone, randomized to lixisenatide either prior to the main meal or breakfast, were studied in the trial.
The primary endpoint of the trial, showing non-inferiority in HbA1c decrease at 24 weeks from baseline when lixisenatide was injected prior to the main meal of the day vs. breakfast, was achieved with mean HbA1c reductions of 0.65% and 0.74% respectively.
The company said that 43.6% of patients in the main meal group and 42.8% in the breakfast group achieved HbA1c below 7%.
Lyxumia is a once-daily prandial glucagon-like peptide-1 receptor agonist (GLP-1 RA) intended to treat patients with type 2 diabetes mellitus.
The drug is also approved in Mexico, Australia, Japan, Brazil, Colombia and Chile for the treatment of adults with type 2 diabetes.
It was in-licensed from Zealand Pharma and is approved in Europe for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control.
Sanofi intends to re-file the New Drug Application for lixisenatide in the US in 2015, following completion of the ELIXA cardiovascular outcomes study.
