New Xultophy® data show improvements in some patient reported outcomes versus glargine

Data from the DUAL™ V trial investigating the efficacy and safety of Xultophy® (insulin degludec/liraglutide; IDegLira), in type 2 diabetes patients (T2D) uncontrolled on insulin glargine, were presented at the 51st European Association for the Study of Diabetes (EASD) Annual Meeting. (1)

The results showed greater improvements in treatment related impact and patient reported physical health in people treated with Xultophy® compared to further intensification of glargine. (1) Xultophy® is the first ever treatment combining two existing treatments, long acting (basal) insulin (insulin degludec, Tresiba®) (2) and GLP-1 receptor agonist (liraglutide, Victoza®) (3) in one pen. (4)

Professor Stephen Gough, University of Oxford and Oxford University Hospitals NHS Trust commented, “Type 2 diabetes has a huge impact on the NHS, so it is crucial that patients receive effective treatment. However, the true impact of a treatment goes beyond efficacy and safety endpoints. The patient’s perception of how a treatment influences their wellbeing and daily living is also critical to understanding a therapy’s value. It is for this reason that I’m excited to see that patients’ perception of Xultophy® in the DUAL™ V trial was consistent with the clinical results.”

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Findings from DUAL™ V have previously shown patients treated with Xultophy®:

• Achieved mean reduction in HbA1c of 1.8% from baseline (8.4% to 6.6% (68.3mmol/mol to 48.6mmol/mol)) compared to a 1.1% reduction (8.2% to 7.1% (66.1mmol/mol to 54.1mmol/mol)) achieved by patients increasing their dose of insulin glargine (p<0.001) (5)
• Achieved HbA1c of <7% at the end of the trial (72% versus 47% insulin glargine; p?0.001) (5)
• Achieved an HbA1c <7% without hypoglycaemia and weight gain compared to those treated with insulin glargine (39% versus 12%; p<0.001) (5)

Patient reported outcomes were assessed by two questionnaires, the Treatment Related Impact Measure for Diabetes (TRIM-D) and Short Form-36 Health Survey (SF-36). TRIM-D generates a score based on five areas: treatment burden, daily life, diabetes management, compliance and psychological health. Patients treated with Xultophy® achieved a greater improvement from baseline in total score (p=0.003), treatment burden (p=0.017) and diabetes management (p<0.001) compared to insulin glargine patients, with no significant difference in the other areas of measurement. (1)

SF-36 is scored in two summary scales: the Physical Component Summary (PCS), a measure of physical health, and the Mental Component Summary (MCS), a measure of emotional health. (1) Patients treated with Xultophy® experienced a significantly greater improvement in the PCS score (p<0.001) than insulin glargine patients, whilst there was no difference with regards to the MCS score between the two arms. (1)

References:

1. Lingvay I 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. Tresiba® Summary of Product Characteristics (SPC). Bagsværd, Denmark, Novo Nordisk A/S; 2015.
3. Victoza® Summary of Product Characteristics (SPC). Bagsværd, Denmark, Novo Nordisk A/S; 2015.
4. Xultophy® Summary of Product Characteristics (SPC). Bagsværd, Denmark, Novo Nordisk A/S; 2015.
5. Buse J et al. Insulin degludec/liraglutide (IDegLira) is superior to insulin glargine (IG) in A1c reduction, risk of hypoglycaemia and weight change: DUAL V study. Diabetes 2015;64(Suppl 1):A43-44 (166-OR).