Tresiba® Showed an Overall Lower Risk of Hypoglycaemia and Significantly Lower HbA1c When Compared to Insulin Glargine U300 in People With Type 2 Diabetes

Barcelona, Spain (ots/PRNewswire) - According to new data from the
CONCLUDE head-to-head trial, Tresiba® (insulin degludec) showed an
overall lower risk of hypoglycaemia, also known as a hypo or low
blood sugar, at a significantly lower HbA1c, compared with insulin
glargine U300 in adults with type 2 diabetes uncontrolled on basal
insulin with or without oral anti-diabetic drugs (OADs). Results from
the CONCLUDE trial were presented today at the 55th Annual Meeting of
the European Association for the Study of Diabetes (EASD 2019) in
Barcelona, Spain.1

The primary endpoint, the rate of overall symptomatic
hypoglycaemia in the maintenance period of 36 weeks which was tested
for superiority, was numerically lower but not statistically
significant versus insulin glargine U300. The rate of overall
symptomatic hypoglycaemia was statistically significantly lower in
favour of Tresiba® during the total treatment period of up to 88
weeks.1

In this head-to-head trial, Tresiba® significantly reduced the
rate of severe hypoglycaemia by 80% and nocturnal symptomatic
hypoglycaemia by 37% when compared with insulin glargine U300 during
the maintenance period, and by 62% and 43% respectively in the total
treatment period when compared with insulin glargine U300.1

"Severe hypoglycaemia can be very worrying and potentially
dangerous for people with diabetes and is important to consider as
part of long-term diabetes care," said Dr Athena Philis-Tsimikas,
CONCLUDE lead investigator and corporate vice president, Scripps
Whittier Diabetes Institute. "The results of this trial reinforce the
safety profile of Tresiba® as it demonstrated a significant reduction
in severe hypoglycaemiacompared to insulin glargine U300 alongside
effective blood glucose control."

The proportion of participants experiencing hypoglycaemia was also
significantly lower in favour of Tresiba® during both the maintenance
and total treatment periods for all hypoglycaemia endpoints. These
reductions in rates and proportions of patients experiencing
hypoglycaemia with Tresiba® were seen alongside significant
reductions from baseline in HbA1c (estimated treatment difference
[ETD] -0.1%) and fasting plasma glucose (ETD -0.62 mmol/L).
Furthermore, Tresiba® showed a 12% lower insulin dose requirement
with an end-of-trial mean daily insulin dose of 67U, compared with
73U for insulin glargine U300.1

"We are delighted that the findings of the CONCLUDE trial support
what we have seen previously across the Tresiba® clinical development
programme," said Mads Krogsgaard Thomsen, executive vice president
and chief science officer of Novo Nordisk. "These findings offer
further confidence that Tresiba® can help people with type 2 diabetes
reduce their risk of hypoglycaemia, without having to compromise
their treatment goals."

About the CONCLUDE trial

The CONCLUDE clinical trial (NCT03078478) was a randomised,
open-label, treat-to-target, multinational trial comparing the risk
of hypoglycaemia with Tresiba® vs insulin glargine U300 in 1,609
adults with type 2 diabetes. Both treatments were administered once
daily, with or without oral anti-diabetic drugs (OADs), in
insulin-experienced participants. Endpoints were assessed during a
36-week maintenance period and a total treatment period of up to 88
weeks.1

The primary endpoint was the overall number of severe (defined as
an event requiring third party assistance) or blood glucose confirmed
(<3.1 mmol/L) symptomatic hypoglycaemic episodes during the
maintenance period. Secondary hypoglycaemia endpoints included the
number of nocturnal symptomatic and the number of severe
hypoglycaemic events during the maintenance period, as well as basal
insulin dose (U) at end of treatment. Other endpoints included change
from baseline to end of treatment in HbA1c and fasting plasma glucose
(FPG) level and all three hypoglycaemia endpoints during the total
treatment period.1

About hypoglycaemia

Hypoglycaemia is when blood sugar levels are too low and cannot
provide the body's organs with the energy they need. Hypoglycaemia
can cause a range of symptoms including confusion, trembling,
sweating, increased heart rate, difficulty with concentration and
speech, and in severe cases it can lead to seizures, coma or even
death.2-5

About Tresiba®

Tresiba® (insulin degludec) is a once-daily basal insulin that
provides a duration of action beyond 42 hours with a flat and stable
glucose-lowering effect.6,7 Tresiba® led to an effective reduction in
HbA1c in clinical trials and showed a lower risk of hypoglycaemia in
studies compared to insulin glargine U100, in particular in type 2
diabetes. It also provides a lower day-to-day variability in glucose
lowering effect versus insulin glargine U100 and insulin glargine
U300.8,9 Tresiba® received its first regulatory approval in September
2012 and has since been approved in more than 80 countries globally.
It is commercially available in more than 61 countries.

Novo Nordisk is a global healthcare company with more than 95
years of innovation and leadership in diabetes care. This heritage
has given us experience and capabilities that also enable us to help
people defeat obesity, haemophilia, growth disorders and other
serious chronic diseases. Headquartered in Denmark, Novo Nordisk
employs approximately 41,600 people in 80 countries and markets its
products in more than 170 countries. For more information, visit
novonordisk.com (file://10.86.178.63/Users/nip/Desktop/Corporate%20Co
mmunications/novonordisk.com), Facebook
(http://www.facebook.com/novonordisk), Twitter
(http://www.twitter.com/novonordisk), LinkedIn
(http://www.linkedin.com/company/novo-nordisk), YouTube
(http://www.youtube.com/novonordisk).

References

1. Philis-Tsimikas A, Klonoff DC, Khunti K, et al. CONCLUDE: a trial
COmparing the efficacy aNd safety of insulin degLUDEc and insulin
glargine 300 units/mL in subjects with type 2 diabetes mellitus
inadequately treated with basal insulin and oral antidiabetic
drugs. Symposium at the 55th Annual Meeting of the European
Association for the Study of Diabetes (EASD), Barcelona, Spain;
16-20 September 2019.
2. Seaquist ER, Anderson J, Childs B, et al. Hypoglycemia and
diabetes: a report of a workgroup of the American Diabetes
Association and the Endocrine Society. Diabetes Care.
2013;36:1384-95.
3. International Hypoglycaemia Study Group. Diagnosis of
hypoglycaemia. Available online at
http://ihsgonline.com/understanding-hypoglycaemia/diagnosis. Last
accessed: July 2019.
4. Cryer PE. Hypoglycemia, functional brain failure, and brain death.
J Clin Invest. 2007; 117:868-870.
5. Ahrén B. Avoiding hypoglycemia: a key to success for
glucose-lowering therapy in type 2 diabetes. Vasc Health Risk
Manag. 2013; 9:155-163.
6. EMA. Tresiba® Summary of Product Characteristics. Available at: ht
tp://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_
Information/human/002498/WC500138940.pdf. Last accessed: July
2019.
7. Haahr H and Heise T. A review of the pharmacological properties of
insulin degludec and their clinical relevance. Clin Pharmacokinet.
2014; 53:787-800.
8. Heise T, Hermanski L, Nosek L, et al. Insulin degludec: Four times
lower pharmacodynamic variability than insulin glargine under
steady-state conditions in type 1 diabetes. Diabetes Obes Metab.
2012; 14:859-864.
9. Heise T, Norskov M, Nosek L, et al. Insulin degludec: Lower
day-to-day and within-day variability in pharmacodynamic response
compared with insulin glargine 300 U/mL in type 1 diabetes.
Diabetes Obes Metab. 2017; 19:1032-1039.

Further information

Media:
Mette Kruse Danielsen +45 3079 3883 mkd@novonordisk.com
Investors:
Peter Hugreffe Ankersen +45 3075 9085 phak@novonordisk.com
Valdemar Borum Svarrer +45 3079 0301 jvls@novonordisk.com
Ann Søndermølle Rendbæk +45 3075 2253 arnd@novonordisk.com

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