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ORLANDO, Fla., June 23, 2018 /PRNewswire/ -- Xultophy^® 100/3.6 (insulin degludec and liraglutide injection) 100 units/mL and 3.6 mg/mL provided superior A1C reduction compared to insulin glargine U-100 (1.94% vs 1.68% respectively; p˂0.0001) when used as an add-on to a SGLT-2i (an oral diabetes medication), according to results from the DUAL IX study presented today at the American Diabetes Association's 78^th Scientific Sessions (ADA) in Orlando, Fla.

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:

• Patient-Reported Outcomes for Insulin Degludec/Liraglutide (IDegLira) vs Insulin Glargine (IGlar U-100) as Add-On to Sodium-Glucose Co-Transporter-2 Inhibitor (SGLT2i) ± Oral Antidiabetic Drug (OAD) Therapy in Patients with Type 2 Diabetes: DUAL IX Trial (Poster Presentation 101-LB)

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).

• Xultophy^® 100/3.6 is not recommended as the first choice of medicine for treating diabetes.
• It is not known if Xultophy^® 100/3.6 can be used in people who have had pancreatitis.
• Xultophy^® 100/3.6 is not recommended for use in combination with any other product containing liraglutide or another GLP-1 receptor agonist.
• Xultophy^® 100/3.6 is not for use in people with type 1 diabetes or people with diabetic ketoacidosis (increased ketones in the blood or urine).
• It is not known if Xultophy^® 100/3.6 can be used with mealtime insulin.
• It is not known if Xultophy^® 100/3.6 is safe and effective for use in children under 18 years of age.

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:

• Possible thyroid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, liraglutide, one of the components of Xultophy^® 100/3.6, and medicines that work like liraglutide caused thyroid tumors, including thyroid cancer. It is not known if Xultophy^® 100/3.6 will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

Who should not use Xultophy^® 100/3.6? Do not use Xultophy^® 100/3.6 if:

• you or any of your family have ever had MTC or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• you are allergic to insulin degludec, liraglutide, or any of the ingredients in Xultophy^® 100/3.6.
• you are having an episode of low blood sugar.

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:

• have or have had problems with your pancreas, kidneys, or liver.
• have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
• are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Xultophy^® 100/3.6 passes into your breast milk.

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?

• Read the Instructions for Use and take Xultophy^® 100/3.6 exactly as your health care provider tells you.
• Do not change your dosing schedule without first talking to your health care provider.
• Do not inject Xultophy^® 100/3.6 into a muscle or vein.
• Use Xultophy^® 100/3.6 at the same time each day with or without food. Do not take more than 50 units of Xultophy^® 100/3.6 each day.
• Check the Pen label each time you give your injection to make sure you are using the correct medication.
• Do not share your Xultophy^® 100/3.6 pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
• Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them.

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?

• Do not drive or operate heavy machinery, until you know how Xultophy^® 100/3.6 affects you. Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

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:

• inflammation of your pancreas (pancreatitis). Stop using Xultophy^® 100/3.6 and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
• low blood sugar (hypoglycemia). Signs and symptoms of low blood sugar may include: shakiness, irritability, fast heartbeat, dizziness, weakness, sweating, confusion, drowsiness, hunger, headache and feeling jittery.
• kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse.
• serious allergic reactions. Stop using Xultophy^® 100/3.6 and get medical help right away, if you have any symptoms of a serious allergic reaction including itching, rash, or difficulty breathing.
• heart failure in some people if taking diabetes medicines called peroxisome proliferator-activated receptor (PPAR) gamma agonists with insulin containing products like Xultophy^® 100/3.6. This can happen even if you have never had heart failure or heart problems. If you already have heart failure, it may get worse while you take PPAR agonists with Xultophy^® 100/3.6. Tell your health care provider if you have any new or worse symptoms of heart failure including shortness of breath, tiredness, swelling of your ankles or feet and sudden weight gain.
• low potassium in your blood (hypokalemia).

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.

References

1. Philis-Tsimikas A, Billings LK, Busch R, et al. Superior Efficacy of Insulin Degludec/Liraglutide (IDegLira) vs Insulin Glargine (IGlar U100) as Add-on to Sodium-Glucose Co-Transporter-2 Inhibitor (SGLT2i) ± Oral Antidiabetic Drug (OAD) Therapy in Patients with Type 2 Diabetes (T2D): DUAL IX Trial (NCT02773368). 78^th Annual Scientific Sessions of the American Diabetes Association (ADA), Orlando, FL, USA, 22-26 June 2018.
2. ClinicalTrials.gov. A clinical trial comparing glycaemic control and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) as add-on therapy to SGLT2i in subjects with type 2 diabetes mellitus (DUAL IX). Available at: https://clinicaltrials.gov/ct2/show/study/NCT02773368. Last accessed: May 2018.
3. Xultophy^® 100/3.6 [package insert]. Plainsboro, NJ: Novo Nordisk Inc; November 2016.

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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