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

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

PARIS - June 9, 2019 - 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.

"We are committed to providing people living with diabetes a broad range of options that can help support personalized care," said Rachele Berria, Global Head of Diabetes Medical Affairs at Sanofi. "As the first comparison between Soliqua and both daily and weekly GLP-1 RA treatments, this study provides physicians with new data that they could use when considering Soliqua as a part of a personalized treatment plan."

About the study

The LixiLan-G study included 514 adults with type 2 diabetes who were inadequately controlled on a GLP-1 RA (either once-daily liraglutide or twice-daily exenatide, or once-weekly exenatide extended release, albiglutide or dulaglutide) and metformin (with or without pioglitazone, with or without a sodium-glucose transport protein 2 inhibitor [SGLT2i]). Participants were randomized to either switch to Soliqua or continue their previous GLP-1 RA treatment, while maintaining their other pre-trial anti-diabetic medication. Adherence to allocated treatment was monitored and reinforced throughout the study.

The primary objective was to demonstrate superior reduction of HbA_1c with Soliqua versus continuation of the previous GLP-1 RA after 26 weeks. Secondary objectives included comparison of the overall efficacy and safety of Soliqua to continued GLP-1 RA treatment.

After 26 weeks, patients who switched to Soliqua saw a 0.6% greater reduction in HbA_1c versus continuing treatment with a GLP-1 RA:

More patients who switched to Soliqua achieved HbA_1c below the 7% target recommended by the ADA versus those treated with GLP-1 RA (difference: 36%, p < 0.0001). The study also evaluated composite targets of HbA_1c below 7% without documented symptomatic hypoglycemia (<54 mg/dL or <=70 mg/dL, respectively):

The study showed a safety profile consistent with previous studies: 22% of patients who switched to Soliqua experienced gastrointestinal events (nausea, diarrhea or vomiting), compared with 10% of patients who continued previous treatment with GLP-1 RA. Rates of hypoglycemia were also consistent with the established safety profiles of the treatments: 9% of patients who treated with Soliqua experienced at least one event, compared with <1% who remained on previous GLP-1 RA therapy.

Participants treated with Soliqua were followed for a further 26 weeks. Data from this extension period will be presented at a later date.