New Xultophy® (IDegLira) Phase 3b Trial Shows Improvements in Patient-Reported Outcomes Versus Insulin Glargine
Sweden (ots/PRNewswire)
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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 [http://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
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, Pérez Manghi F, García 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