Soliqua® Phase 3 results significantly lowered blood sugar levels compared to GLP-1 receptor agonist treatments
10 June 2019 - 3:00AM
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 (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.
About Sanofi
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
|
Media Relations Contact Ashleigh
Koss
Tel.: +1 908-981-8745
Ashleigh.Koss@sanofi.com
|
Investor Relations Contact George
Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com
|
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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
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Source: Sanofi via Globenewswire
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