Sanofi's Fixed-Ratio Combination Helps More Patients Reach Mealtime Blood Sugar Target than Insulin Glargine Alone
(Thomson Reuters ONE) -
Sanofi's Fixed-Ratio Combination Helps More Patients Reach Mealtime Blood Sugar
Target than Insulin Glargine Alone
- Titratable fixed-ratio combination of insulin glargine
and lixisenatide demonstrates better post-prandial glycemic control in adults
with type 2 diabetes -
Paris, France - September 13, 2016 - Sanofi announced today that iGlarLixi, the
investigational, titratable fixed-ratio combination of insulin glargine 100
Units/mL and GLP-1 receptor agonist lixisenatide*, offers greater control of
mealtime blood sugar (post-prandial glucose, PPG) in adults living with type 2
diabetes compared to insulin glargine 100 Units/mL alone. A new post-hoc
analysis of data from the LixiLan-L pivotal Phase III clinical trial found more
patients who received the fixed-ratio combination reached their daily PPG target
than those who received only insulin glargine 100 Units/mL. The new analysis was
presented at the European Association for the Study of Diabetes (EASD) 52(nd)
Annual Meeting in Munich, Germany. iGlarLixi is currently under review in the
United States and Europe.
"Controlling mealtime blood sugar is an important element of maintaining overall
blood sugar control, which plays a role in helping patients treat their
diabetes," said Josep Vidal, Hospital Clinic of Barcelona, Barcelona, Spain, and
lead author of the study. "This new analysis provides further evidence
supporting the use of iGlarLixi by adults with type 2 diabetes who need mealtime
blood sugar control alongside greater control of their HbA1c."
The analysis also showed that a significantly higher proportion of participants
reached their PPG target after 30 weeks, according to self-measured plasma
glucose (SMPG) taken at intervals throughout the day. As previously reported for
LixiLan-L, incidence of symptomatic hypoglycemia was similar with the titratable
fixed-ratio combination and insulin glargine 100 Units/mL.
"In the LixiLan-L pivotal Phase III clinical trial, investigational iGlarLixi
demonstrated superior HbA1c reduction compared with insulin glargine 100
Units/mL alone," said Riccardo Perfetti, Head of Global Diabetes Medical Team,
Sanofi. "With this new analysis, we see further evidence of the role iGlarLixi
can serve in helping type 2 diabetes patients meet their PPG targets."
The presentation abstract is titled 'Post-Prandial Glycemic Outcomes of a Fixed
Ratio Combination of Insulin Glargine and Lixisenatide in the LixiLan-L Trial
(NCT02058147)' (Vidal, J et al. Poster presentation 801 - EASD 52(nd) Annual
Meeting in Munich, Germany at 13:15 p.m. CET on September 13)
Summary of Results
The post-hoc analysis reviewed data from the LixiLan-L pivotal Phase III trial,
which compared the effectiveness of the two treatments in 736 adults whose type
2 diabetes was not adequately controlled at screening on insulin glargine alone
or combined with one or two oral anti-diabetic agents. The primary outcome of
the LixiLan-L study, a statistically significant reduction in HbA1c (average
blood glucose over the previous three months) compared with insulin glargine
100 Units/mL, was previously reported at the American Diabetes Association
76(th) Scientific Sessions, 2016.
In the 677 participants included in the post-hoc analysis with standardized meal
test data at baseline and week 30, the fixed-ratio combination demonstrated
greater PPG control compared with insulin glargine 100 Units/mL. The percentage
of patients achieving PPG <=7.8 mmol/L at Week 30 was greater in the fixed-ratio
combination group versus the insulin glargine 100 Units/mL group at 0.5 hour
(difference: 16.4% [41.4% vs. 25%], p<0.0001); one hour (difference: 22.4%
[30.7% vs. 8.3%], p<0.0001) and two hour (difference: 28.2% [33.6% vs. 5.4%],
p<0.0001) after a standardized liquid meal.
The fixed-ratio combination also demonstrated greater PPG control compared with
insulin glargine 100 Units/mL in the 592 participants included in the post-hoc
analysis with 7-point self-measured plasma glucose (SMPG) data at baseline and
week 30. Consistently, more patients reached PPG targets after all meals
throughout the day. The percentage of patients achieving PPG <=7.8 mmol/L in a
7-point SMPG test at Week 30 was greater in the fixed-ratio combination group
versus the insulin glargine 100 Units/mL group at 10 a.m. (difference: 32.5%
[61.2% vs. 28.7%], p<0.0001); 3 p.m. (difference: 16.5% [41.1% vs. 24.6%],
p<0.0001) and 10 p.m. (difference: 12.2% [45.9% vs. 33.7%], p=0.005).
As previously reported for LixiLan-L, documented (<=70 mg/dL /3.9 mmol/L)
incidence of symptomatic hypoglycemia was similar with the titratable fixed-
ratio combination (40% of patients; 3.0 events/year; E/Y) and insulin glargine
100 Units/mL (42.5% of patients; 4.2 E/Y). With the titratable fixed-ratio
combination, 10.4% of participants experienced nausea, and 3.6% experienced
vomiting; while with insulin glargine 100 Units/mL 0.5% of participants
experienced nausea and 0.5% experienced vomiting.
About Sanofi Diabetes & Cardiovascular
Diabetes and cardiovascular disease affect millions of people worldwide, with
many managing the complex challenges of both. Building on our portfolio
evolution, heritage and expertise, Sanofi has a focused business unit dedicated
to delivering innovative, value-based medicines and integrated solutions in
these therapeutic areas. We are committed to a collaborative approach that
involves strategic alliances with professional and patient associations,
research institutions and leaders in healthcare and other industries, with the
goal of advancing scientific knowledge, driving the convergence of science and
technology, helping to improve outcomes and inspiring an evolution in care.
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes
therapeutic solutions focused on patients' needs. Sanofi is organized into five
global business units: Diabetes and Cardiovascular, General Medicines and
Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. Sanofi is listed in
Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private
Securities Litigation Reform Act of 1995, as amended. Forward-looking statements
are statements that are not historical facts. These statements include
projections and estimates and their underlying assumptions, statements regarding
plans, objectives, intentions and expectations with respect to future financial
results, events, operations, services, product development and potential, and
statements regarding future performance. Forward-looking statements are
generally identified by the words "expects", "anticipates", "believes",
"intends", "estimates", "plans" and similar expressions. Although Sanofi's
management believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and uncertainties, many
of which are difficult to predict and generally beyond the control of Sanofi,
that could cause actual results and developments to differ materially from those
expressed in, or implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other things, the
uncertainties inherent in research and development, future clinical data and
analysis, including post marketing, decisions by regulatory authorities, such as
the FDA or the EMA, regarding whether and when to approve any drug, device or
biological application that may be filed for any such product candidates as well
as their decisions regarding labelling and other matters that could affect the
availability or commercial potential of such product candidates, the absence of
guarantee that the product candidates if approved will be commercially
successful, the future approval and commercial success of therapeutic
alternatives, Sanofi's ability to benefit from external growth opportunities,
and/or obtain regulatory clearances, risks associated with intellectual property
and any related pending or future litigation and the ultimate outcome of such
litigation, trends in exchange rates and prevailing interest rates, volatile
economic conditions, the impact of cost containment initiatives and subsequent
changes thereto, the average number of shares outstanding as well as those
discussed or identified in the public filings with the SEC and the AMF made by
Sanofi, including those listed under "Risk Factors" and "Cautionary Statement
Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for
the year ended December 31, 2015. Other than as required by applicable law,
Sanofi does not undertake any obligation to update or revise any forward-looking
information or statements.
*Lixisenatide was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen:
ZEAL), www.zealandpharma.com
Contacts:
Global Media Relations Investor Relations
Mai Tran George Grofik
Tel.: +33 (0) 1.53.77.49.86 Tel.: + (33) 1 53 77 45 45
mai.tran(at)sanofi.com ir(at)sanofi.com
Global Diabetes Communications
Philip McNamara
Tel.: +1 908 981 5497
philipmcnamara(at)sanofi.com
Press release:
http://hugin.info/152918/R/2041645/761887.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Sanofi via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 13.09.2016 - 11:59 Uhr
Sprache: Deutsch
News-ID 494472
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