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10-Jun-2019

Xultophy® (IDegLira) significantly delays time-to-treatment intensification, compared to insulin glargine U100, in adults with type 2 diabetes

Bagsværd, Denmark, 9 June 2019 ­ – According to new data from the DUAL VIII clinical trial published today in The Lancet Diabetes and Endocrinology, Xultophy® (IDegLira) significantly delayed time-to-treatment intensification when compared to insulin glargine U100 (median >2 years versus 1 year, respectively), in adults with type 2 diabetes inadequately controlled on oral treatments (OADs).1

Over 104 weeks, ~63% of study participants who received Xultophy® did not require additional treatment, compared to ~34% of those who received insulin glargine U100.1 With the goal of mirroring clinical practice, participants were followed on average every three months, and met treatment intensification criteria when HbA1c measurements were ≥7% over two consecutive periods.1

“In this trial we were not just looking at clinical markers, such as HbA1c or effect on weight, but were addressing a key clinical question: how long would each treatment help patients achieve and maintain effective blood sugar control once initiated”, said Vanita Aroda, MD, Director of Diabetes Clinical Research at Brigham and Women’s Hospital and lead trial investigator. “This study has shown us that, in this population of patients inadequately controlled on oral treatments, initiation with IDegLira has shown the potential to double the length of time in good glucose control, compared to treatment initiation with insulin glargine U100. In clinical practice this becomes relevant as the longer a patient can remain in good control, the less exposure there is to high blood sugar, and the fewer escalations, or changes, in therapy are required.”

After 104 weeks, on average, the study participants receiving Xultophy® required significantly less insulin units (37 vs 52), experienced a significantly lower weight gain (+1.7 kg vs +3.4 kg), and had a 56% lower rate of severe or blood glucose-confirmed symptomatic hypoglycaemia (low blood sugar), compared with those receiving insulin glargine U100. There were no apparent or unexpected safety or tolerability issues with Xultophy® in this trial, and the safety profile was consistent with data from the previous DUAL trials.1

“Treatment intensification can increase the burden that diabetes brings to those living with type 2 diabetes, requiring them to spend more time managing their condition”, said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “These results show that Xultophy® might help them delaying the need for more complex solutions, such as basal bolus therapy, hopefully reducing the impact of diabetes in their daily life”.

About the trial

The DUAL VIII was a phase 3, 104-week international open-label, treat-to-target trial involving 1,012 adults with type 2 diabetes uncontrolled on oral antidiabetic medications (HbA1c 7.0–11.0%). Participants were randomised 1:1 to Xultophy® or insulin glargine U100. The primary endpoint was time from randomisation to treatment intensification (HbA1C ≥7.0% at two consecutive visits). Participants who met the primary endpoint discontinued the study treatment, and continued trial follow-up outside the study treatment arms.1

The results of the DUAL VIII trial reinforce the safety profile and effectiveness of Xultophy® that has already been established through the DUAL clinical trial programme, and through real-world studies.

About Xultophy®

Xultophy® is a once-daily fixed-ratio combination injection of a basal insulin (insulin degludec), and a glucagon-like peptide 1 (GLP-1) receptor agonist (liraglutide), in one pre-filled pen that can be administered independently of meals, at any time of the day, preferably at the same time of day. 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 basal insulin do not provide adequate glycaemic control.2

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 95 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 43,200 people in 80 countries and markets its products in more than 170 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.

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Last Updated: 10-Jun-2019