- 166-OR
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BOSTON, June 7, 2015 /CNW/ - New phase 3b findings showed
adults with type 2 diabetes treated with Xultophy®
(IDegLira), a once-daily, single-injection combination of insulin
degludec and liraglutide, demonstrated statistically significant
reduction in HbA1c(average blood glucose over the
previous three months), change in body weight and a lower rate of
hypoglycaemia compared with patients treated with insulin
glargine.[1]
To view the Multimedia News Release, please click:
http://www.multivu.com/players/English/7542051-xultophy-phase-3b-study/
Findings from the phase 3b DUAL™ V 26-week trial that compared
the efficacy and safety of Xultophy® versus insulin
glargine, both added on to metformin, in patients with type 2
diabetes uncontrolled on insulin glargine (20-50 units/day), were
presented today at the 75th Annual Scientific Sessions of the
American Diabetes Association (ADA) in Boston, Massachusetts, United States.[1]
At 26 weeks, patients randomised to Xultophy®
treatment achieved a statistically significant mean reduction in
HbA1c of 1.8% from baseline (8.4% to 6.6%) compared with
a 1.1% reduction (8.2% to 7.1%) achieved by patients who further
increased their dose of insulin glargine
(p<0.001).[1] In the Xultophy® group, 72%
of patients achieved an HbA1c of <7% at the end of
the trial, compared with 47% of patients in the insulin glargine
group (p˂0.001).[1] Furthermore, 39% of patients treated
with Xultophy® achieved an HbA1c <7%
without hypoglycaemia and weight gain versus 12% treated with
insulin glargine (p<0.001).[1]
"The results demonstrated that IDegLira treatment could
positively impact patients who are not in control on their current
basal insulin therapy," said Professor John
Buse, University of North
Carolina School of Medicine, Chapel Hill, North Carolina, US. "IDegLira
patients achieved an end of trial mean HbA1c of 6.6%
while still experiencing weight reduction, and had significantly
less hypoglycaemia than patients taking higher doses of insulin
glargine."
There was a 57% lower rate of confirmed hypoglycaemia with
Xultophy® compared with insulin glargine (2.23
episodes/patient-year vs 5.05 episodes/patient-year;
p<0.001).[1] Additionally, there was a significant
difference of 3.2 kg (7.1 lb) in change in body weight between
treatment groups (p<0.001); body weight decreased by 1.4 kg (3.0
lb) from baseline for patients treated with Xultophy®
and increased by 1.8 kg (4.0 lb) for patients treated with insulin
glargine.[1] Patients treated with
Xultophy® required significantly less insulin than
patients treated with insulin glargine, demonstrated by the
end-of-trial dose of 41 units of the insulin degludec component in
Xultophy® versus 66 units respectively
(p<0.001).[1]
In the DUAL™ V trial, there were similar rates of overall and
serious adverse events in the two treatment
groups.[1]
Also presented during the scientific meeting were additional
patient-reported outcomes (PRO) data measured by TRIM-D (Treatment
Related Impact Measure-Diabetes) and SF36 v2 (Short-Form 36 Health
Survey version 2) from DUAL™ V:
- Insulin Degludec/Liraglutide (IDegLira) Improves
Patient-Reported Impacts in Subjects With Type 2 Diabetes (T2D)
Inadequately Controlled on Insulin Glargine (IG) Plus Metformin
(Met): DUAL™ V Study (Abstract #2550-PO).
About
Xultophy®
Xultophy® is a once-daily single injection
combination of Tresiba® (insulin degludec), a once-daily
basal insulin analogue with an ultra-long duration of action and
Victoza® (liraglutide), a once-daily human GLP-1
analogue.[2] The maximum dose of Xultophy® is
50 dose steps (equivalent to 50 units of insulin degludec and 1.8
mg of liraglutide). Xultophy® is being investigated in
the DUAL™ clinical trial programme which includes two phase 3a and
a number of phase 3b trials, encompassing more than 3,500 people
with type 2 diabetes. Xultophy® was granted marketing
authorisation by the European Commission on 18 September 2014 and approved in Switzerland on 12
September 2014.[2],[3]
About DUAL™ V
DUAL™ V was a phase 3b, 26-week, treat-to-target, randomised,
open-label, multicentre trial conducted in 10 countries with 557
patients. The trial was designed to show non-inferiority in
HbA1c and to subsequently demonstrate superiority in
HbA1c, body weight and hypoglycaemia. The trial compared
the efficacy and safety of Xultophy® versus insulin
glargine, both added on to metformin, in adults with type 2
diabetes uncontrolled on insulin glargine (20-50 units). The
pre-trial mean dose of insulin glargine was 32 units. Patients
could be titrated to the maximum dose of Xultophy®
(equivalent to 50 units of insulin degludec and 1.8 mg of
liraglutide) and there was no maximum daily dose of insulin
glargine.[1],[4]
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90
years of innovation and leadership in diabetes care. This heritage
has given us experience and capabilities that also enable us to
help people defeat other serious chronic conditions: haemophilia,
growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately
39,000 people in 75 countries and markets its products in more than
180 countries. For more information,
visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube
References
1. Buse J, et al . Insulin Degludec/Liraglutide
(IDegLira) is Superior to Insulin Glargine (IG) in A1c reduction,
Risk of Hypoglycaemia and Weight Change: DUAL V Study. Oral
presentation (#166-OR) at the 75th Scientific Sessions of the
American Diabetes Association (ADA), 7 June
2015.
2. EMA. Xultophy® Summary of Product Characteristics. Available
at:
http://ec.europa.eu/health/documents/community-register/2014/20140918129550/anx_129550_en.pdf
Last accessed: 03.02.2015.
3. SwissMedic. Xultophy®: Information for Professionals.
22.09.2014.
4. ClinicalTrials.gov. NCT01952145. A Trial Comparing the
Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin
Glargine in Subjects With Type 2 Diabetes Mellitus (DUAL™ V).
Available at:
https://www.clinicaltrials.gov/ct2/show/study/NCT01952145?show_locs=Y#locn
Last accessed: 03.02.2015.
Video:
http://www.multivu.com/players/English/7542051-xultophy-phase-3b-study/
SOURCE Novo Nordisk A/S