Sanofi's Lyxumia(R) (lixisenatide) Showed More Pronounced After-Test-Meal Blood Sugar Lowering Than Liraglutide When Both Were Added to Insulin Glargi
PR57069
Sanofi's Lyxumia(R) (lixisenatide) Showed More Pronounced After-Test-Meal Blood Sugar Lowering Than Liraglutide When Both Were Added to Insulin Glargine
PARIS, June 15/PRN=KYODO JBN/--
Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that Lyxumia(R)
(lixisenatide) met the primary endpoint in an 8-week head-to-head
pharmacodynamic study versus liraglutide, showing a significantly more
pronounced post-prandial (after-meal) glucose (blood sugar) lowering effect
after a test-meal than liraglutide when both were added to optimally titrated
Lantus(R) (insulin glargine). Lowering of post-prandial glucose was measured as
change from baseline in incremental area under the glucose curve for 4 hours
after a standardized solid breakfast, at week 8.
Findings also showed that while both lixisenatide and liraglutide lowered
blood glucose (HbA1c) when added to optimally titrated insulin glargine,
lixisenatide treatment resulted in fewer reports of gastrointestinal adverse
events, a lower mean increase in heart rate and smaller increases from baseline
to week 8 in pancreatic enzyme (amylase and lipase) levels. The most commonly
reported adverse events in the study were symptomatic hypoglycemia and nausea.
Symptomatic hypoglycemia was more frequent in the lixisenatide group compared
to the liraglutide group. (Full results are available in the Results of
Analysis section.) Lixisenatide is currently approved in Europe and an
investigational drug in the United States, where it is not approved.
"In this Phase II head-to-head study we saw a significant difference in the
post-prandial glucose lowering effects of lixisenatide and liraglutide, two
GLP-1 receptor agonists, with similar overall blood sugar reductions," said
Riccardo Perfetti, Senior Medical Officer, Vice President Global Medical
Affairs, Diabetes Division, Sanofi. "The results showed that both medicines
reduced blood glucose, but we found that lixisenatide did this with a greater
delay in gastric emptying, and its use was associated with differences in
safety and tolerability compared to liraglutide. These differences are
interesting and could be further explored to determine whether differences in
gastric emptying benefit patients by lowering the post-prandial glucose
excursion and whether gastric emptying corresponds to differences in safety and
tolerability."
These results were presented at the 74th Scientific Sessions of the
American Diabetes Association, San Francisco, CA. The abstract is titled:
Effect of Lixisenatide vs Liraglutide on Glycemic Control, Gastric Emptying,
and Safety Parameters in Optimized Insulin Glargine T2DM plus or minus
Metformin. (Meier et al. Poster presentation #1017-P, June 14, 2014).
Results of Analysis
This 8-week, randomized, open-label, three-arm parallel trial, comparing
lixisenatide 20microg with liraglutide 1.2mg and 1.8mg QD in 142 patients with
type 2 diabetes on optimally titrated (SMPG of 80-100mg/dL) insulin glargine
treatment with or without metformin, met its primary endpoint. Results showed a
greater reduction in post-prandial glucose (PPG) from baseline with
lixisenatide (-240.2h.mg/dL, SE 20.0) than with liraglutide 1.2mg
(-131.8h.mg/dL, SE 20.2) and 1.8mg (-157.1h.mg/dL, SE 21.0) for 4 hours after a
standardized solid breakfast (p<0.0001).
At week 8, HbA1c decreased significantly from baseline (p<0.05) for all
groups, and final HbA1c levels were similar in all treatment arms (6.2 plus or
minus 0.4 for lixisenatide, 6.1 plus or minus 0.3 for liraglutide 1.2mg, and
6.1 plus or minus 0.3 for liraglutide 1.8mg). Body weight decreased
significantly in all groups (-1.61 plus or minus 0.47kg, p<0.05 for
lixisenatide, -1.78 plus or minus 0.48kg, p<0.05 for liraglutide 1.2mg, and
-2.42 plus or minus 0.49kg, p<0.0001 for liraglutide 1.8mg).
Symptomatic hypoglycemia was slightly more frequent with lixisenatide (14
events with lixisenatide versus 9 and 10 events with liraglutide 1.2mg and
1.8mg, respectively). There was one case of severe symptomatic hypoglycemia in
the lixisenatide arm and one case of mild asymptomatic confirmed pancreatitis
in the liraglutide 1.8mg arm.
In addition, lixisenatide significantly delayed gastric emptying more than
liraglutide 1.2mg and 1.8mg (LS mean change plus or minus SE for gastric
emptying lag time: 175.6 plus or minus 23.7 [lixisenatide, p<0.0001 for change
from baseline] vs. 70.1 plus or minus 23.8 [liraglutide 1.2 mg, p<0.05 for
change from baseline] and 48.9 plus or minus 24.6 [liraglutide 1.8 mg p<0.05
for change from baseline]; LS mean change plus or minus SE for gastric emptying
half time: 453.6 plus or minus 58.2 [lixisenatide, p<0.0001 for change from
baseline] vs. 175.3 plus or minus 58.5 [liraglutide 1.2 mg, p<0.05 for change
from baseline] and 130.5 plus or minus 60.3 [liraglutide 1.8 mg p<0.05 for
change from baseline]). There were more gastrointestinal adverse events (GI
AEs) reported with liraglutide than with lixisenatide (21 and 22 with
liraglutide 1.2mg and 1.8mg, respectively, versus 17 with lixisenatide) with
nausea reported in 8 and 11 with liraglutide 1.2mg and 1.8mg respectively,
versus 9 with lixisenatide. Liraglutide treatment also resulted in greater
increases from baseline to week 8 in the levels of the pancreatic enzymes
amylase and lipase compared with lixisenatide (amylase: +8.01IU/L, SE 4.00 and
+5.68IU/L, SE 4.13 for liraglutide 1.2mg and 1.8mg, respectively, versus
+2.98IU/L, SE 4.00 for lixisenatide; lipase: +21.12IU/L, SE 7.16 and
+20.76IU/L, SE 7.38, versus +6.97IU/L, SE 7.11). Mean ambulatory monitored
24-hour increase in heart rate was greater with liraglutide 1.2mg and 1.8mg
than with lixisenatide (9bpm for liraglutide, 3bpm for lixisenatide, p<0.0001),
with no significant differences in 24-hour blood pressure.
About Lixisenatide
In Europe, Lyxumia(R) (lixisenatide) is approved as a once-daily prandial
glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of
patients with type 2 diabetes mellitus. It remains under investigation in the
U.S. 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 was approved in Europe in 2013 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 currently approved in over 40 countries worldwide
for the treatment of adults with type 2 diabetes, with commercial launches in
Europe, Japan, Mexico and other markets. 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, a 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).
Forward Looking Statements
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statements are statements that are not historical facts. These statements
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SOURCE: Sanofi Diabetes
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