New Data Support Flexibility in Timing of Administration for Sanofi's Lyxumia(R)
New Data Support Flexibility in Timing of Administration for Sanofi's Lyxumia(R)
PR55235
PARIS, Dec. 5 /PRN=KYODO JBN/ --
- Similar glucose lowering effect when once-daily Lyxumia
is administered before breakfast or the main meal -
Sanofi (EURONEXT : SAN and NYSE : SNY) announced today the results of a 24-week
Phase IIIb clinical study showing that Lyxumia(R) (lixisenatide) met the
primary endpoint of non-inferiority in blood sugar lowering (HbA1c) when
administered either before breakfast or the main meal of the day. These results
indicate that lixisenatide can effectively lower blood sugar at either time of
administration.
"Helping patients reach their HbA1c goal is the main objective of type 2
diabetes treatment," said Professor Bo Ahren, Faculty of Medicine, Lund
University, Sweden. "Flexibility in timing of administration is also an
important attribute, especially for injectable diabetes therapies. This study
shows that once-daily lixisenatide meets these criteria, which is significant
for an agent that is prescribed for use in combination with existing treatment
regimens."
The results also showed that a comparable reduction in body weight, regardless
of the meal before which lixisenatide was administered, was achieved. In
addition, gastrointestinal tolerability was comparable regardless of time of
administration, with no cases of severe hypoglycemia in either arm. The data
were shared during an oral presentation at the World Diabetes Congress 2013 in
Melbourne, Australia.
Results of Analysis
The 24-week Phase IIIb study examined 451 patients with type 2 diabetes,
uncontrolled on metformin alone, randomized to lixisenatide either prior to the
main meal or prior to breakfast. Lunch (as defined by questioning patients) was
the main meal of the day for 53% of patients.
The primary endpoint of the study, demonstrating non-inferiority in HbA1c
decrease at 24 weeks from baseline when lixisenatide was injected prior to the
main meal of the day vs. breakfast, was successfully achieved with mean HbA1c
reductions of 0.65% and 0.74% respectively. In addition, 43.6% of patients in
the main meal group and 42.8% in the breakfast group achieved HbA1c below 7%.
The mean change in body weight was -2.6kg in the main meal group and -2.8kg in
the breakfast group. Gastrointestinal tolerability was comparable between the
two groups (nausea 14.7% and 15.5% and vomiting 2.7% and 3.5%, respectively)
and the incidence of symptomatic hypoglycemia was low in both groups, with no
severe cases.
This study abstract is entitled: 'Flexibility in timing of lixisenatide
administration prior to either the main meal of the day or the breakfast in
T2DM patients' (Ahren B, et al. Oral presentation December 5, 2013, 10:45-12:45
[ABS OP-0454]).
About Lyxumia(R) (lixisenatide)
Lyxumia(R) (lixisenatide) is a once-daily prandial glucagon-like peptide-1
receptor agonist (GLP-1 RA) for the treatment of patients with type 2 diabetes
mellitus. GLP-1 is a naturally-occurring peptide hormone that is released
within minutes after eating a meal. It is known to suppress glucagon secretion
from pancreatic alpha cells and stimulate glucose-dependent insulin secretion
by pancreatic beta cells.
Lyxumia was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL),
http://www.zealandpharma.com, and is approved in Europe for the treatment of
adults with type 2 diabetes mellitus to achieve glycemic control in combination
with oral glucose-lowering medicinal products and/or basal insulin when these,
together with diet and exercise, do not provide adequate glycemic control.
Lyxumia is also approved in Mexico, Australia, Japan, Brazil, Colombia and
Chile for the treatment of adults with type 2 diabetes. Sanofi plans to
resubmit the New Drug Application for lixisenatide in the United States in
2015, after completion of the ELIXA cardiovascular outcomes study. Lyxumia is
the proprietary name approved by the European Medicines Agency and other health
authorities for the GLP-1 RA lixisenatide.
The Lyxumia pen is the winner of a number of innovative design awards,
including the Good Design Award 2012 and the iF Product Design Award. The
variant of the Lyxumia pen used in Japan won the Good Design Award (G Mark)
2013.
About Sanofi Diabetes
Sanofi strives to help people manage the complex challenge of diabetes by
delivering innovative, integrated and personalized solutions. Driven by
valuable insights that come from listening to and engaging with people living
with diabetes, the Company is forming partnerships to offer diagnostics,
therapies, services, and devices including blood glucose monitoring systems.
Sanofi markets both injectable and oral medications for people with type 1 or
type 2 diabetes.
About Sanofi
Sanofi, an integrated global healthcare leader, discovers, develops and
distributes therapeutic solutions focused on patients' needs. Sanofi has core
strengths in the field of healthcare with seven growth platforms: diabetes
solutions, human vaccines, innovative drugs, consumer healthcare, emerging
markets, animal health and the new Genzyme. Sanofi is listed in Paris
(EURONEXT: SAN) and in New York (NYSE: SNY).
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ended December 31, 2012. Other than as required by applicable law, Sanofi does
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information or statements.
SOURCE: Sanofi Diabetes
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