ORLANDO, Fla., June 23, 2018 /PRNewswire/ -- Xultophy® 100/3.6 (insulin degludec and liraglutide injection) 100 units/mL and 3.6 mg/mL provided
DUAL IX was a phase 3b, 26-week, open-label clinical trial that compared Xultophy® 100/3.6 to insulin glargine U-100 in adults with type 2 diabetes uncontrolled on SGLT-2i treatment, with or without other oral antidiabetic drugs.1 Xultophy® 100/3.6 is not indicated for use as an add-on to oral diabetes medications.
Results from some of the secondary endpoints in DUAL IX included change from baseline in body weight, severe or blood glucose confirmed symptomatic hypoglycaemic events and daily insulin dose at 26 weeks. Mean body weight remained unchanged in the Xultophy® 100/3.6 study group versus a 2.0 kg (4.4 lb) weight gain with insulin glargine U-100.1 Treatment with Xultophy® 100/3.6 demonstrated a 58% lower rate of hypoglycaemia versus insulin glargine U-100 (0.37 events/patient-year of exposure vs 0.90 events/patient-year of exposure respectively; p=0.0035). The average total daily insulin dose was significantly less with Xultophy® 100/3.6 than insulin glargine U-100 (36 units per day vs 54 units per day respectively; p?0.0001).
"Type 2 diabetes is a progressive disease that often requires treatment intensification," said Dr. Athena Philis-Tsimikas, DUAL IX lead investigator and corporate vice president, Scripps Whittier Diabetes Institute. "Xultophy® 100/3.6 may be an appropriate treatment option for those adults who are unable to meet their blood sugar goals on their current medication."
Adverse events were similar across both treatment groups; the most common adverse events (?5%) in the Xultophy® 100/3.6 treated patients included viral upper respiratory tract infection, headaches, back pain, increased lipase, and nausea. The safety profile of Xultophy® 100/3.6 in DUAL IX was consistent with previous Xultophy® 100/3.6 clinical trials.1
Additional DUAL IX patient-reported outcomes were presented at the meeting:
About DUAL IX DUAL IX was a phase 3b, 26-week, randomised, open-label, multicentre trial conducted in 11 countries including 420 patients. The trial was designed to investigate the safety and efficacy of Xultophy® 100/3.6 versus insulin glargine U-100 as add-on therapy in adults uncontrolled on sodium-glucose co-transporter-2 inhibitor (SGLT-2i) treatment with or without additional oral antidiabetic drug therapy.2 A hypoglycaemic event in DUAL IX was defined as an event requiring assistance from another person or blood glucose (BG) confirmed (less than 56 mg/dL) with symptoms consistent with hypoglycaemia.
About Xultophy® 100/3.6 Xultophy® 100/3.6 is a combination of insulin degludec, a long-acting human insulin analogue, and liraglutide, a glucagon-like peptide 1 (GLP-1) receptor agonist, indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily).3
What is Xultophy® 100/3.6 (insulin degludec and liraglutide injection) 100 units/mL and 3.6 mg/mL? Xultophy® 100/3.6 is an injectable prescription medicine that contains 2 diabetes medicines, insulin degludec, 100 units/mL, and liraglutide, 3.6 mg/mL. Xultophy® 100/3.6 should be used along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes mellitus when blood sugar levels are not well controlled on: 1) basal insulin (less than 50 units daily) or 2) liraglutide (less than or equal to 1.8 mg daily).
Important Safety Information
What is the most important information I should know about Xultophy® 100/3.6? Xultophy® 100/3.6 may cause serious side effects, including:
Who should not use Xultophy® 100/3.6? Do not use Xultophy® 100/3.6 if:
What should I tell my health care provider before using Xultophy® 100/3.6? Tell your health care provider about all your medical conditions, including if you:
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Before using Xultophy® 100/3.6, talk to your health care provider about low blood sugar and how to manage it.
How should I use Xultophy® 100/3.6?
Your dose of Xultophy® 100/3.6 may need to change because of change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or other medicines you take.
What should I avoid while taking Xultophy® 100/3.6?
What are the possible side effects of Xultophy® 100/3.6? Xultophy® 100/3.6 may cause serious side effects that can be life-threatening, including:
The most common side effects of Xultophy® 100/3.6 may include stuffy or runny nose, sore throat, upper respiratory tract infection, increased blood levels of lipase, nausea, diarrhea, and headache.
Please click here for Prescribing Information.
About Novo Nordisk
Novo Nordisk, a global healthcare company, has been committed to discovering and developing innovative medicines to help people living with diabetes lead longer, healthier lives for 95 years. This heritage has given us experience and capabilities that also enable us to help people defeat other serious diseases including obesity, hemophilia and growth disorders. We remain steadfast in our conviction that the formula for success is to stay focused, think long term and do business in a financially, socially and environmentally responsible way. With U.S. headquarters in New Jersey and production and research facilities in four states, Novo Nordisk employs nearly 6,000 people throughout the country. For more information, visit novonordisk.us, Facebook and Twitter.
Xultophy® 100/3.6 is a registered trademark of Novo Nordisk A/S. Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2018 Novo Nordisk All rights reserved. US18XUM00023 June 2018
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SOURCE Novo Nordisk
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