GUILDFORD, England,
August 4, 2015 /PRNewswire/ --
- New once-daily
basal insulin demonstrated similar
glycaemic control with a lower incidence of
confirmed hypoglycaemia when compared to
Lantus® in the treatment of
adults with type 2
diabetes[1]
-
Sanofi announced today that Toujeo® (insulin glargine
[rDNA origin] 300 units/mL), a long-acting, once-daily basal
insulin treatment is available for clinicians to prescribe in the
UK, providing another option for adults with type 1 and type 2
diabetes mellitus to help manage their condition. Insulin glargine
300 units/ml is indicated for the treatment of diabetes mellitus in
adults[1] and is a novel
formulation of the glargine molecule Lantus® (insulin
glargine 100 units/mL) currently used in the treatment of
diabetes.[2]
There are currently 3.3 million people in the UK diagnosed with
diabetes[3] a figure predicted to
rise to an estimated five million people by
2025.[4] Over two thirds of adults
treated with insulin do not reach the National Institute for Health
and Care Excellence (NICE) target for blood glucose control
(HbA1c ≤ 7.5%),[5]
increasing their risk of potentially avoidable complications such
as amputation, blindness and renal
disease.[4] Many clinicians cite
concern of hypoglycaemia as a reason for not managing blood glucose
more aggressively - three quarters (75.5%) of specialists would be
more aggressive in treating diabetes if there was no concern about
hypoglycaemia.[6] For patients,
concern over hypoglycaemia may cause them to modify their insulin
dose - four out of ten people with type 2 diabetes reduce their
insulin dose after an episode of mild hypoglycaemia and six out of
ten after a severe hypoglycaemic
episode.[7]
Melanie Davies, Professor of
Diabetes Medicine, University of Leicester and Honorary Consultant, University
Hospitals Leicester commented: "This new basal insulin is an
additional treatment option for doctors to help manage patients who
are not currently able to reach optimal glycaemic control.
Hypoglycaemia is one of the most frequent adverse events
experienced by people treated with insulin and fear of these events
can prevent some patients administering appropriate insulin doses
and can even lead to discontinuation of treatment. The consequence
may be poor blood glucose control and an increased risk of
long-term complications."
Results from clinical trials evaluating the efficacy and
tolerability of insulin glargine 300 units/mL compared to insulin
glargine 100 units/mL demonstrated a similar blood glucose
(HbA1c) reduction with a lower incidence of confirmed
hypoglycaemia in patients with type 2 diabetes on insulin glargine
300 units/mL compared to those on insulin glargine 100
units/ml.[1] In patients with type
1 diabetes, trials demonstrated similar blood glucose
(HbA1c) reduction but showed no difference in confirmed
hypoglycaemia.[1] Insulin glargine
300 units/mL also showed a more stable and more prolonged glucose
lowering effect that lasted beyond 24 hours, and low
within-individual blood-sugar
variability.[1]
Dr David Williams, Medical
Director for Sanofi UK said, "The availability of Toujeo in the UK
is a significant milestone for Sanofi as we expand our portfolio of
medicines for patients with both type 1 and type 2 diabetes and
reinforces our commitment to continue improving the quality of
diabetes care."
Insulin glargine 300 units/mL was licensed by the European
Medicines Agency (EMA) in February
2015. It has also been licensed by the U.S. Food and Drug
Administration (FDA) and is under review by other regulatory
authorities around the world.
Insulin glargine 300 units/mL forms a compact subcutaneous depot
with a reduced surface
area[8],[9]
and allows for a slower, more prolonged release of insulin glargine
beyond 24
hours.[8]-[10]
Insulin glargine 300 units/mL and insulin glargine 100 units/mL are
not bioequivalent and therefore are not
interchangeable.[1] Switching from
once-daily insulin glargine 300 units/mL, to insulin glargine 100
units/mL results in an increased risk of hypoglycaemic events,
mainly in the first week after the switch. To reduce this risk,
patients should reduce their dose by 20%. When switching to or from
insulin glargine 300 units/mL, close metabolic monitoring is
recommended during the transition and in the initial weeks
thereafter.[1]
For more information about insulin glargine 300 units/mL and for
its side effect profile please refer to the Summary of Products
Characteristics.
About Diabetes in the UK
There are 3.3 million people in the UK currently diagnosed with
diabetes[3] and this is predicted
to rise to an estimated five million people by
2025.[4] The estimated split
between people with type 2 and type 1 diabetes is 90:10.
Additionally, it is believed that there are approximately 630,000
people in the UK who have diabetes but do not know
it.[4] The NHS spends around £10
billion (10 per cent of its total budget) on diabetes; that's about
£1 million every hour.[4] When
including the indirect costs associated with managing people with
diabetes in the UK the overall cost is estimated at £23.7 billion
and is predicted to rise to almost £40 billion by
2035/6.[11]
About the EDITION Study Programme
EDITION results demonstrated that insulin glargine 300 units/mL,
when compared to insulin glargine 100 units/mL
conferred:[1]
- Non-inferior blood glucose control in adult type 1 and type 2
diabetes over the six month study period
- Lower incidence of confirmed hypoglycaemia (at any time of the
day and nocturnal) in type 2 diabetes over the six month study
period
- Confirmed hypoglycaemia:
- 11% relative risk reduction (relative risk (RR): 0.89 [95%
confidence interval (CI): 0.83 to 0.96], absolute risk (AR) 57.6%
vs 64.5%, [absolute risk reduction (ARR): 6.9%]) for those treated
in combination with non-insulin anti-hyperglycaemic medicinal
product
- 7% relative risk reduction (RR: 0.93 [95% CI: 0.88 to 0.99], AR
81.9% vs 87.8%, [ARR: 5.9%]) for those treated in combination with
a mealtime insulin (+/- metformin)
- No significant difference in severe hypoglycaemia (at any time
of the day and nocturnal) in type 2 diabetes over the six month
study period:
- Severe hypoglycaemia:
- 18% relative risk reduction (RR: 0.82 [95% CI: 0.33 to 2.00],
AR 1.0% vs 1.2%, [ARR: 0.2%]) for those treated in combination with
non-insulin anti-hyperglycaemic medicinal product
- 13% relative risk reduction (RR: 0.87 [95% CI: 0.48 to 1.55],
AR 5.0% vs 5.7%, [ARR: 0.7%]) for those treated in combination with
a mealtime insulin (+/- metformin)
- Reduced risk of nocturnal hypoglycaemia in type 2 diabetes from
week nine to the end of the study period (6 months)
- 18% relative risk reduction (RR: 0.82 [95% CI: 0.68 to 0.99],
AR 18.4% vs 22.5%, [ARR: 4.1%]) for those treated in combination
with non-insulin anti-hyperglycaemic medicinal product
- 21% relative risk reduction (RR: 0.79 [95% CI: 0.67 to 0.93],
AR 36.1% vs 46.0%, [ARR: 9.9%]) for those treated in combination
with a mealtime insulin
- Similar incidence of hypoglycaemia in type 1 diabetes over the
six month study period
About Sanofi Diabetes
Sanofi strives to help people manage the complex challenge of
diabetes by delivering innovative, integrated and personalised
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 diabetes solutions, human vaccines,
innovative drugs, consumer healthcare, emerging markets, animal
health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
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, the
Group's ability to benefit from external growth
opportunities, trends in exchange rates and prevailing interest
rates, the impact of cost containment policies 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,
2013. Other than as required by applicable law, Sanofi does
not undertake any obligation to update or revise any
forward-looking information or statements.
References
- Toujeo (insulin glargine 300 units/mL Summary of Product
Characteristics (SmPC). Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000309/WC500047935.pdf.
Accessed 11 June 2015
- EMA Committee for Medicinal Products for Human Use (CHMP)
Summary of Opinion. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/000309/WC500183282.pdf.
Accessed 11 June 2015
- Quality and Outcomes Framework (QOF) 2013/2014
- Diabetes UK. Diabetes Facts and Stats. Available at:
http://www.diabetes.org.uk/Documents/About%20Us/Statistics/Diabetes-key-stats-guidelines-April2014.pdf.
Accessed 11 June 2015
- Sanofi Data on File. SAGB.DIA.14.10.0602.
- Peyrot M et al.Diabetes Med 2012;29:682-689
- Leiter LA et al. Can J Diabetes. 2005;29:186-192
- Owens DR et al. Diabetes Metab Res Rev 2014; 30: 104-119
- Shiramoto M et al. Diabetes Obes Metab. 2015
Mar;17(3):254-60
- Becker RHA et al. Diabetes Care 2015 Apr;38(4):637-43
- Hex N et al. Diabetic Medicine 2012. 29(7):855-862