Soliqua® Phase 3 results significantly lowered blood sugar levels compared to GLP-1 receptor agonist treatments
June 09 2019 - 1:01PM
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.
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|
Media Relations Contact
Ashleigh Koss Tel.: +1 908-981-8745 Ashleigh.Koss@sanofi.com |
Investor Relations Contact
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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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