New Data Support Flexibility in Timing of Administration for Sanofi's Lyxumia(R)

PARIS, Dec. 5, 2013 /PRNewswire/ --

- Similar glucose lowering effect when once-daily Lyxumia is administered before breakfast or the main meal -

Sanofi (EURONEXT: SAN and NYSE: SNY) announced today the results of a 24-week Phase IIIb clinical study showing that Lyxumia^® (lixisenatide) met the primary endpoint of non-inferiority in blood sugar lowering (HbA_1c) when administered either before breakfast or the main meal of the day. These results indicate that lixisenatide can effectively lower blood sugar at either time of administration.

"Helping patients reach their HbA_1c goal is the main objective of type 2 diabetes treatment," said Professor Bo Ahren, Faculty of Medicine, Lund University, Sweden. "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."

The results also showed that a comparable reduction in body weight, regardless of the meal before which lixisenatide was administered, was achieved. In addition, gastrointestinal tolerability was comparable regardless of time of administration, with no cases of severe hypoglycemia in either arm. The data were shared during an oral presentation at the World Diabetes Congress 2013 in Melbourne, Australia.

Results of Analysis

The 24-week Phase IIIb study examined 451 patients with type 2 diabetes, uncontrolled on metformin alone, randomized to lixisenatide either prior to the main meal or prior to breakfast. Lunch (as defined by questioning patients) was the main meal of the day for 53% of patients.

The primary endpoint of the study, demonstrating non-inferiority in HbA_1c decrease at 24 weeks from baseline when lixisenatide was injected prior to the main meal of the day vs. breakfast, was successfully achieved with mean HbA_1c 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 HbA_1c below 7%. The mean change in body weight was -2.6kg in the main meal group and -2.8kg in the breakfast group. Gastrointestinal tolerability was comparable between the two groups (nausea 14.7% and 15.5% and vomiting 2.7% and 3.5%, respectively) and the incidence of symptomatic hypoglycemia was low in both groups, with no severe cases.

This study abstract is entitled: 'Flexibility in timing of lixisenatide administration prior to either the main meal of the day or the breakfast in T2DM patients' (Ahren B, et al. Oral presentation December 5, 2013, 10:45−12:45 [ABS OP-0454]).