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Bagsværd, Denmark, June 9, 2019 – According to new data from the clinical trial DUAL VIII published today in The Lancet Diabetes and Endocrinology, Xultophy® (IDegLira) significantly delayed the increase in treatment time compared with insulin glargine U100 (median> 2 years vs. 1 year, respectively) in adults with type 2 diabetes undertreated under oral therapy (ADO) .1
More than 104 weeks, about 63% of study participants who received Xultophy® did not require any additional treatment, compared to about 34% of people who received insulin glargine U100.1 In order to reflect clinical practice, participants were followed on average every three months and met the criteria for intensification of treatment when HbA1 C measurements were ≥ 7% over two consecutive periods.1
"In this trial, we were not interested only in clinical markers, such as HbA.1 C or an effect on weight, but answered a key clinical question: how long would each treatment help patients achieve and maintain effective blood glucose control once in place, "said Vanita Aroda, MD, director of Clinical research on diabetes at Brigham Hospital and Women's Investigator. "This study showed us that in this population of patients inadequately controlled by oral treatments, initiation with IDegLira showed the potential to double the duration of glycemic control, compared with the initiation of insulin glargine U100 treatment. In clinical practice, this becomes relevant since the longer the patient can remain under control, the lower the exposure to hyperglycemia, and the less it is necessary to make increases or changes in the blood pressure. treatment. "
After 104 weeks, on average, study participants receiving Xultophy® required significantly fewer insulin units (37 vs. 52), took a significantly lower weight gain (+1.7 kg vs. +3.4 kg) and exhibited a rate of severe symptomatic hypoglycemia or confirmed by blood sugar (blood sugar) lower by 56%. with those receiving insulin glargine U100. Xultophy does not present any apparent or unexpected safety or tolerability issues.® in this trial and the safety profile was consistent with data from previous DUAL trials.1
"Increasing treatment can increase the burden of diabetes for people with type 2 diabetes, forcing them to spend more time managing their disease," said Mads Krogsgaard Thomsen, Executive Vice President and Chief Executive Officer. Scientific Director of Novo Nordisk. "These results show that Xultophy® could help them delay the need for more complex solutions, such as basal bolus therapy, by hopefully reducing the impact of diabetes in their daily lives. "
About the trial
DUAL VIII was a 104-week, international, open-label, Phase 3 trial involving 1,012 adults with type 2 diabetes not controlled by oral antidiabetic agents (HbA).1 C 7.0 to 11.0%). Participants were randomized 1: 1 to Xultophy® or insulin glargine U100. The main criterion was the delay between randomization and intensification of treatment (HbA level).1 C ≥7.0% on two consecutive visits). Participants who met the primary endpoint discontinued treatment at study and continued follow-up of the trial outside the treatment groups of the study.1
The results of the DUAL VIII trial reinforce the safety profile and effectiveness of Xultophy® this has already been established by the DUAL clinical trial program and by real world studies.
About Xultophy®
Xultophy® is a single dose combination injection of basal insulin (insulin degludec) and a glucagon-like peptide 1 (GLP-1) agonist (liraglutide) once daily, in a 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 in the treatment of adults with type 2 diabetes to improve glycemic control in combination with oral hypoglycemic medications, when these alone or in combination with basal insulin do not allow a adequate glycemic control.2
About Novo Nordisk
Novo Nordisk is a global healthcare company with over 95 years of innovation and leadership in the treatment of diabetes. This legacy has given us experience and capabilities that also allow us to help people overcome obesity, hemophilia, growth disorders and other diseases. serious chronicles. 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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