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 (HbA1c) 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 HbA1c 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 HbA1c 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 79th 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 HbA1c 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 HbA1c versus continuing treatment with a GLP-1 RA:
Soliqua
GLP-1 RA
Mean HbA1c at baseline
7.86%
7.88%
Mean HbA1c at Week 26
6.7%
7.4%
Reduction in HbA1c
-1.02%
-0.38%
Least squares mean difference
-0.64%
95% Confidence interval
-0.77 to -0.51
p-value
<0.0001
More patients who switched to Soliqua achieved HbA1c 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 HbA1c below 7% without documented symptomatic hypoglycemia (<54 mg/dL or <=70 mg/dL, respectively):
Soliqua
GLP-1 RA
% of patients achieving HbA1c < 7%
62%
26%
% of patients achieving HbA1c < 7% with no documented (<=70 mg/dL) symptomatic hypoglycemia
43%
25%
% of patients achieving HbA1c < 7% with no documented (<54 mg/dL) symptomatic hypoglycemia
57%
25%
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.
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[1] Blonde L et al, Presentation #149 OR, American Diabetes Association 79th Scientific Sessions, June 9, San Francisco, CA, U.S.
[2] Soliqua® is an injectable prescription medicine that contains two diabetes medicines, insulin glargine and lixisenatide. Soliqua® is marketed in the EU as Suliqua®, where it is indicated in combination with metformin for the treatment of adults with type 2 diabetes mellitus to improve glycemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin. It is marketed in the U.S. as Soliqua® 100/33, where it is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is marketed as Soliqua® in other geographies where it is approved
