New Xultophy(R) (IDegLira) Phase 3b Trial Shows Improvements in Patient-Reported Outcomes Versus Insulin Glargine

PR61803

STOCKHOLM, Sweden, Sept. 15, 2015PRNewswire=KYODO JBN/ --

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    New findings from the DUAL(TM) V phase 3b clinical trial showed greater

improvements in treatment-related satisfaction and patient-reported physical

health in people treated with Xultophy(R) versus insulin glargine U100.[1] The

DUAL(TM) V trial evaluated the efficacy and safety of Xultophy(R) (IDegLira), a

once-daily single-injection combination of Tresiba(R) (insulin degludec) and

Victoza(R) (liraglutide) compared to further intensification with insulin

glargine U100 in adults with type 2 diabetes uncontrolled on insulin glargine

U100.

    The findings based on validated patient-reported outcomes (PRO)

questionnaires completed by participants in the DUAL(TM) V trial were announced

today at the 51st European Association for the Study of Diabetes (EASD) in

Stockholm, Sweden.[1]

    "The true impact of a treatment on a patient's life goes beyond efficacy

and safety endpoints. The patient's perception of how a treatment influences

their well-being and daily living is critical for understanding a therapy's

value," said Professor Stephen Gough, University of Oxford and Oxford

University Hospitals NHS Trust. "It is for this reason we're excited to see

that patients' positive perception in the DUAL(TM) V trial was consistent with

the clinical results."

    PRO data provide patients' perspective on quality of life (QoL) and

treatment satisfaction. This type of data is valuable because it reflects

patients' thoughts, complaints and opinions that researchers couldn't otherwise

measure or observe.[2] PRO from the DUAL(TM) V trial were assessed by two

questionnaires, the Treatment Related Impact Measure for Diabetes (TRIM-D) and

Short Form-36 Health Survey (SF-36). The collected data are scored in

categories known as domains.

    The TRIM-D generates a total score based on the assessment of five domains:

treatment burden, daily life, diabetes management, compliance and psychological

health. Patients treated with Xultophy(R) achieved a significantly greater

improvement from baseline in TRIM-D total score than patients treated with

insulin glargine U100 (p=0.003).[1] In particular, patients treated with

Xultophy(R) experienced significantly greater improvement in the TRIM-D

domains, treatment burden (p=0.017) and diabetes management (p＜0.001) than

patients treated with insulin glargine U100.[1]

    SF-36 is a validated generic questionnaire that can be scored into eight

domains and two overall component summary scales: the physical component

summary (PCS) which is a measure of physical health, and the mental component

summary (MCS), which is a measure of emotional health.[1] Patients treated with

Xultophy(R) experienced a significantly greater improvement in the PCS

(p＜0.001) score than patients treated with insulin glargine U100, whilst there

was no difference with regards to the MCS score between the two arms. [1]

    In addition, findings from the DUAL(TM) V clinical trial demonstrated that

people with type 2 diabetes treated with Xultophy(R) versus insulin glargine

U100 achieved superior HbA1c reductions (1.8% vs 1.1%; p＜0.001), body

weight change (1.4 kg decrease vs 1.8 kg increase, a 3.2 kg difference;

p＜0.001) and a 57% lower rate of confirmed hypoglycaemia (2.2 vs 5.1

events per patient year exposure; p＜0.001).[3][4]

    About Xultophy(R)

    Xultophy(R) is a once-daily single injection combination of Tresiba(R)

(insulin degludec), a once-daily basal insulin analogue, and Victoza(R)

(liraglutide), a once-daily human GLP-1 analogue.[5] The maximum dose of

Xultophy(R) is 50 dose steps (equivalent to 50 units of insulin degludec and

1.8 mg of liraglutide). Xultophy(R) is being investigated in the DUAL(TM)

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(R)

was granted marketing authorisation by the European Commission on 18 September

2014 and approved in Switzerland on 12 September 2014.[5][6]

    About DUAL(TM) V

    DUAL(TM) 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 rate of hypoglycaemia. The

trial compared the efficacy and safety of Xultophy(R)  versus insulin glargine,

both added on to metformin, in adults with type 2 diabetes uncontrolled on

insulin glargine (20-50 units). The pretrial mean dose of insulin glargine was

32 units. Patients could be titrated to the maximum dose of Xultophy(R)

(equivalent to 50 units of insulin degludec and 1.8 mg of liraglutide) and

there was no maximum daily dose of insulin glargine.[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 39,700 people in

75 countries and markets its products in more than 180 countries. For more

information, visit novonordisk.com

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    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

Melanie Raouzeos +45-3075-3479 mrz@novonordisk.com  Daniel Bohsen +45-3079-6376

dabo@novonordisk.com Frank Daniel Mersebach (U.S.) +1-609-235-8567

fdni@novonordisk.com

     References

    1. Lingvay I, Perez Manghi FC, Garcia-Hernandez PA, et al. Insulin

degludec/liraglutide (IDegLira) improves patient-reported outcomes in subjects

with type 2 diabetes uncontrolled on insulin glargine + metformin: DUAL V

Study. (#831) at 51st European Association for the Study of Diabetes (EASD), 16

September 2015. Stockholm, Sweden.

    2. Fayers P, Machin D. Quality of Life: The Assessment, Analysis and

Interpretation of Patient-reported Outcomes. 2007.

    3. Buse J, Perez Manghi F, Garcia Hernandez P, et al. Insulin

degludec/liraglutide (IDegLira) is superior to insulin glargine (IG) in A1c

reduction, risk of hypoglycemic and weight change: DUAL[TM] V study. Oral

presentation (#166-OR) at the 75th Scientific Sessions of the American Diabetes

Association (ADA), 7 June 2015.

    4. Buse JB, Perez Manghu FC, Garcia-Hernandez PA, et al. Insulin

degludec/liraglutide (IDegLira) is superior to insulin glargine (IGlar) in

HbA1c reduction, risk of hypoglycaemia and weight change: DUAL[TM] V Study.

Presentation (#836) at the 51st European Association for the Study of Diabetes

(EASD), 16 September 2015.

    5. EMA. Xultophy(R) summary of product characteristics. Available at:

http://ec.europa.eu/health/documents/community-register/2014/20140918129550/anx_129550_en.pdf

Last accessed: 1 June 2015.

    6. SwissMedic. Xultophy(R): information for professionals.

    ZINC ID: HQMMA/XT/0815/0274

Source: Novo Nordisk