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Xultophy trial shows improvements in patient-reported outcomes
17 September 2015 • Author: Victoria White
New findings from the DUAL V Phase 3b clinical trial showed greater improvements in treatment-related satisfaction and patient-reported physical health in people treated with Novo Nordisk‘s Xultophy versus insulin glargine U100.
The DUAL V trial evaluated the efficacy and safety of Xultophy (IDegLira), a once-daily single-injection combination of Tresiba (insulin degludec) and Victoza (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 V trial were announced at the 51st European Association for the Study of Diabetes (EASD) in Stockholm, Sweden.
“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 of Xultophy in the DUAL V trial was consistent with the clinical results.”
Patients treated with Xultophy achieved a greater improvement in treatment burden
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 could not otherwise measure or observe. PRO from the DUAL 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 achieved a significantly greater improvement from baseline in TRIM-D total score than patients treated with insulin glargine U100. In particular, patients treated with Xultophy experienced significantly greater improvement in the TRIM-D domains, treatment burden and diabetes management than patients treated with insulin glargine U100.
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. Patients treated with Xultophy experienced a significantly greater improvement in the PCS score than patients treated with insulin glargine U100, whilst there was no difference with regards to the MCS score between the two arms.
In addition, findings from the DUAL V clinical trial demonstrated that people with type 2 diabetes treated with Xultophy versus insulin glargine U100 achieved superior HbA1c reductions, body weight change and a 57% lower rate of confirmed hypoglycaemia.
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