Xultophy® Reported a Better Option than Basal-Bolus Insulin Therapy to Manage Type 2 Diabetes by Participants in the DUAL VII Clinical Trial

Abu Dhabi, Uae (ots/PRNewswire) -

Once-daily Xultophy® (insulin degludec/liraglutide) was a better
option to manage diabetes compared to multiple daily injections of
insulin (basal-bolus regimen). This was reported by people with type
2 diabetes whose blood sugar was not controlled on insulin glargine
U100 with metformin, and who completed quality-of-life questionnaires
as part of the DUAL VII clinical trial.[1] In addition, more people
preferred to stay on Xultophy® compared with basal-bolus therapy
(84.5% versus 68.1%).[1] These results were presented today at the
2017 International Diabetes Federation Congress in Abu Dhabi, UAE.

"Adding insulin injections at mealtime is an effective option to
achieve desired blood glucose levels when basal insulin is not
enough, but this raises the level of complexity in the patients'
daily management of their diabetes. It can also lead to an increased
risk of hypoglycaemia (low blood sugar) or weight gain", said
Professor Esteban Jódar, University Hospital Quirón Salud, Madrid,
Spain. "In the main analysis of the DUAL VII trial, Xultophy®
delivered similar glucose reductions to a basal-bolus regimen
alongside weight loss, as opposed to weight gain, and fewer episodes
of hypoglycaemia. We now see that it also reduces treatment burden."

In the patient-reported outcomes (PRO) analysis from the DUAL VII
clinical trial, 506 adults living with type 2 diabetes assessed their
physical health, mental health and a number of diabetes-specific
factors. These scores were measured using the validated
Treatment-Related Impact Measure-Diabetes (TRIM-D) questionnaire and
the Short Form Health Survey 36 v2 (SF-36)[1].

The participants in the study treated with Xultophy® reported
better experiences for all diabetes-specific factors compared to the
ones in the basal-bolus treatment regimen, with the highest
improvement in TRIM-D scores given for diabetes management (16.7
versus 6.8), treatment burden (12.4 versus 4.3) and compliance (9.1
versus 3.9). The analysis of the SF-36 questionnaire results found
that Xultophy® was associated with a statistically significant higher
score compared to basal-bolus insulin regimen for the mental health
component of the questionnaire; all other comparisons were
non-significant.[1]

"Living with diabetes is a complex situation in itself, and the
treatment should not add to this. We are very pleased to see that
Xultophy® not only helps people with type 2 diabetes reach their
blood glucose targets while reducing the risk of hypoglycaemia and
helping them to lose weight, but does this in a simple way", said
Mads Krogsgaard Thomsen, executive vice president and chief science
officer of Novo Nordisk. "This is a key component of what innovation
in diabetes means to us. It's about making the lives of people with
diabetes as easy as possible."

About the analysis

This analysis is based on PRO data collected during the DUAL VII
clinical trial using different health questionnaires. The TRIM-D
questionnaire is specific to diabetes. The SF-36 is a generic health
questionnaire used to assess quality of life measures. Motivation to
stay on treatment was measured using an additional motivation
questionnaire.[1]

In DUAL VII, Xultophy® induced greater improvements in PROs,
mainly in outcome measures related to diabetes management, treatment
burden and compliance versus basal-bolus therapy in people with HbA1c
7.0-10% switched from insulin glargine U100 with metformin. People on
Xultophy® had an equal reduction in HbA1c, a lower rate of
hypoglycaemia, fewer injections per day and weight loss versus
basal-bolus insulin treatment. Improvement in the PRO measurements
with Xultophy® corresponded with desirable clinical outcomes. The
open-label nature of the trial was a limitation and could have
influenced the results.[1]

Changes in PRO scores were calculated from baseline after 26 weeks
of treatment. Per definition, PRO data came directly from patients,
without interpretation of the patient's response by a clinician or
anyone else.[2]

About DUAL VII

DUAL VII was a phase 3b, 26-week, randomised, open-label,
multicentre trial conducted in 12 countries including 506
patients.[3] The trial was designed to investigate the safety and
efficacy of Xultophy® versus basal-bolus therapy in adults with type
2 diabetes previously treated with insulin glargine U100 and
metformin.[3]

About Xultophy[®]

Xultophy® is a once-daily single injection fixed-ratio combination
of long-acting insulin degludec and the glucagon-like
peptide-1(GLP-1) receptor agonist liraglutide in one pen. It is
indicated for the treatment of adults with type 2 diabetes mellitus
to improve glycaemic control in combination with oral
glucose-lowering medicinal products when these alone or combined with
a GLP-1 receptor agonist or basal insulin do not provide adequate
glycaemic control. Xultophy® can be administered at any time of the
day with or without meals, preferably at the same time of the day.[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 obesity, haemophilia, growth disorders and other
serious chronic diseases. Headquartered in Denmark, Novo Nordisk
employs approximately 41,700 people in 77 countries and markets its
products in more than 165 countries. For more information, visit
www.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)

Further information

Media:
Katrine Sperling +45 4442 6718 krsp@novonordisk.com
Åsa Josefsson +45 3079 7708 aajf@novonordisk.com

Investors:
Peter Hugreffe Ankersen +45 3075 9085 phak@novonordisk.com
Hanna Ögren +45 3079 8519 haoe@novonordisk.com
Anders Mikkelsen +45 3079 4461 armk@novonordisk.com
Christina Kjær +45 3079 3009 cnje@novonordisk.com
Kasper Veje (US) +1 609 235 8567 kpvj@novonordisk.com

References

1. Jodar E, Doshi A, Gouet D, et al. Patient-reported outcomes
with insulin degludec/liraglutide (IDegLira) vs. basal-bolus therapy
in patients with type 2 diabetes: DUAL VII trial. Congress of the
International Diabetes Federation (IDF 2017). 2017.

2. US Department of Health and Human Services Food and Drug
Administration. Guidance for industry: Patient-reported outcome
measures: Use in medical product development to support labeling
claims. 2009. Available at: http://www.fda.gov/downloads/Drugs/Guidan
ceComplianceRegulatoryInformation/Guidances/UCM193282.pdf Last
accessed: November 2017.

3. ClinicalTrials.gov. A Clinical Trial Comparing Efficacy and
Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus
Therapy in Subjects With Type 2 Diabetes Mellitus. Available at: http
s://clinicaltrials.gov/ct2/show/NCT02420262?term=ideglira%2C+basal-bo
lus&rank=1. Last accessed: November 2017.

4. EMA. Xultophy® Summary of Product Characteristics. Available
at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Produ
ct_Information/human/002647/WC500177657.pdf. Last accessed: November
2017.

ots Originaltext: Novo Nordisk A/S
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Original-Content von: Novo Nordisk A/S, übermittelt durch news aktuell