Sanofi Soliqua Phase 3 meets primary objective: American Diabetes Assn

Soliqua^® Phase 3 results significantly lowered blood sugar levels compared to GLP-1 receptor agonist treatments

• Patients switched to Soliqua reached an average blood sugar below the American Diabetes Association recommended level of 7%
• Full Phase 3 data presented today at the American Diabetes Association (ADA) 79th Scientific Sessions

In a Phase 3 study^[1] evaluating adults with type 2 diabetes inadequately controlled by GLP-1 receptor agonist (GLP-1 RA) treatments, Soliqua^®/Suliqua^®[2] (insulin glargine 100 Units/mL and lixisenatide) met the primary study objective by demonstrating a statistically superior reduction of average blood sugar level (HbA_1c) after 26 weeks, compared with continuing GLP-1 RA treatment.

The LixiLan-G study included either a daily or once-weekly GLP-1 RA treatment as comparator. More patients who switched to Soliqua achieved HbA_1c levels below 7%, a target recommended by the ADA, compared with those who stayed on previous GLP-1 RA therapy. More patients who switched to Soliqua also achieved the composite endpoint of HbA_1c below 7% without documented symptomatic hypoglycemia (low blood sugar levels).

The study showed a safety profile consistent with the established profiles of the treatments studied: the most common classes of adverse event were gastrointestinal events (i.e., nausea, diarrhea and or vomiting) and hypoglycemia.

The full Phase 3 data results were presented today for the first time as an oral presentation at the 79^th Scientific Sessions of the ADA in San Francisco.

https://www.globenewswire.com/news-release/2019/06/09/1866092/0/en/Soliqua-Phase-3-results-significantly-lowered-blood-sugar-levels-compared-to-GLP-1-receptor-agonist-treatments.html