Sanofi’s diabetes drug Lyxumia meets primary endpoint in Phase IIIb study

6th December 2013 (Last Updated December 6th, 2013 05:20)

French pharmaceutical firm 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 given to patients either before breakfast or the main meal.

French pharmaceutical firm 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 given to patients either before breakfast or the main meal.

The results showed that lixisenatide can effectively lower blood sugar at either time of administration and also achieve 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, with no cases of severe hypoglycemia 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.

"Flexibility in timing of administration is also an important attribute, especially for injectable diabetes therapies."

"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."

A total of 451 patients with type 2 diabetes, uncontrolled on metformin alone, randomised to lixisenatide either prior to the main meal or breakfast, were examined in the 24-week Phase IIIb 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.

In addition, 43.6% of patients in the main meal group and 42.8% in the breakfast group achieved HbA1c below 7%, according to the company.

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 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.

It is also approved in Mexico, Australia, Japan, Brazil, Colombia and Chile for the treatment of adults with type 2 diabetes.

Sanofi intends to re-file the new drug application for lixisenatide in the US in 2015, subject to the completion of the ELIXA cardiovascular outcomes study.

Lyxumia is the proprietary name approved by the European Medicines Agency (EMA) and other health authorities for the GLP-1 RA lixisenatide.