Phase III trials of iGlarLixi (insulin glargine + lixisenatide) meet primary endpoints in type 2 diabetes- Sanofi

Sanofi announced the presentation of the results of the pivotal Phase III LixiLan-O and LixiLan-L clinical trials with iGlarLixi (basal insulin glargine 100 Units/mL and lixisenatide) in adults with type 2 diabetes. Both studies met their primary endpoints, demonstrating statistically superior reduction of HbA1c (average blood glucose over the previous three months) with the titratable fixed-ratio combination versus comparators (lixisenatide and insulin glargine 100 Units/mL, respectively).The most frequent adverse events were nausea, vomiting and diarrhea.

In LixiLan-O, after 30 weeks, the titratable fixed-ratio combination showed significantly greater reductions in HbA1c from baseline (8.1%) versus insulin glargine 100 Units/mL and lixisenatide, reaching mean HbA1c levels of 6.5%, 6.8%, 7.3%, respectively. More subjects reached target HbA1c below 7% with the titratable fixed-ratio combination (74%) versus insulin glargine 100 Units/mL (59%) or lixisenatide (33%). Mean body weight increased with insulin glargine 100 Units/mL (+1.1kg), and decreased with the titratable fixed-ratio combination (-0.3kg) and lixisenatide (-2.3kg).

In LixiLan-L, after 30 weeks, the titratable fixed-ratio combination showed significantly greater reductions in HbA1c from baseline (8.1%) versus insulin glargine 100 Units/mL (-1.1% versus -0.6%), reaching mean HbA1c levels of 6.9% and 7.5%, respectively. More subjects reached target HbA1c below 7% with the titratable fixed-ratio combination (55%) versus insulin glargine 100 Units/mL (30%). Mean body weight increased with insulin glargine 100 Units/mL (+0.7 kg), and decreased with the titratable fixed-ratio combination (-0.7 kg). Full results were presented at the American Diabetes Association 76th Scientific Sessions. Top-line results were previously reported in Q3 of 2015.