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

PR71342

ABU DHABI, UAE, Dec. 5, 2017 /PRNewswire=KYODO JBN/ --

     Once-daily Xultophy(R) (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(R) 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(R) 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(R) 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(R) 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(R) 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(R) 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(R) 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(R) 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(R) versus basal-bolus therapy

in adults with type 2 diabetes previously treated with insulin glargine U100

and metformin.[3]

    About Xultophy[(R)]

    Xultophy(R) 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(R) 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 novonordisk.com [https://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;

Asa 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 Kjaer

+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/GuidanceComplianceRegulatoryInformation/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:

https://clinicaltrials.gov/ct2/show/NCT02420262?term=ideglira%2C+basal-bolus&rank=1.

Last accessed: November 2017.

    4.    EMA. Xultophy(R) Summary of Product Characteristics. Available at:

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002647/WC500177657.pdf

. Last accessed: November 2017.

Source:  Novo Nordisk