SAN DIEGO, June 10, 2017 /PRNewswire/ -- New results from the phase 3b DUAL VII clinical trial showed that Xultophy® 100/3.6 (insulin degludec and liraglutide injection) 100 units/mL and 3.6 mg/mL demonstrated similar A1C reductions with significantly lower rates of hypoglycemia and a decrease in weight in adults with type 2 diabetes compared to treatment with basal-bolus therapy (insulin glargine U100 and insulin aspart). Results from the trial were presented today at the American Diabetes Association's 77th Scientific Sessions (ADA) in San Diego, CA, U.S.
In DUAL VII, Xultophy® 100/3.6 demonstrated non-inferiority in lowering A1C when compared to insulin glargine U100 in combination with insulin aspart.1 Those treated with Xultophy® 100/3.6 versus basal-bolus therapy also:
- reached similar glycemic targets (66.0% vs 67.0% for A1C <7%; 49.6% vs 44.6% for A1C ≤6.5%, respectively)
- demonstrated an 89% reduction in severe or blood glucose confirmed symptomatic hypoglycemic events (p<0.0001) and a 92% reduction for nocturnal severe or blood glucose confirmed symptomatic hypoglycemic events (p<0.0001)
- experienced a weight reduction of 0.93 kg (2.06 lb) compared with a weight gain of 2.64 kg (5.81 lb) for people treated with the basal-bolus regimen (p<0.0001)
- achieved glycemic control (A1C <7%) with no hypoglycemic episodes and no weight gain in the last 12 weeks (38.2% vs 6.4% respectively, odds ratio [OR]: 10.39 [5.76; 18.75], 95% confidence interval [CI]).
"The results of DUAL VII show that Xultophy® 100/3.6 provided a similar reduction in A1C compared to basal-bolus therapy while significantly reducing the number of hypoglycemic events along with a reduction in weight," said Todd Hobbs, M.D., U.S. chief medical officer, Novo Nordisk. "These findings reinforce the importance of the ongoing development of new medicines to help adults better manage their type 2 diabetes."
Furthermore, patients treated with Xultophy® 100/3.6 required a lower daily insulin dose compared with the basal-bolus treatment group (40 units vs 84 units; p<0.0001).1 Adverse events were similar across both treatment groups; the most common adverse events (≥5%) in the Xultophy® 100/3.6 treated patients included upper respiratory tract infection, influenza, nausea, headache and diarrhea. The safety profile of Xultophy® 100/3.6 in DUAL VII was generally consistent with previous Xultophy® 100/3.6 clinical trials.
Additional DUAL VII analyses presented during the meeting were results from a short-term cost-effectiveness analysis and patient reported outcomes:
- Evaluation of the Short-term Cost-effectiveness of Insulin Degludec/Liraglutide (IDegLira) versus Basal-Bolus Therapy in Patients with Type 2 Diabetes in the United States (Abstract #981-P)
- Patient- Reported Outcomes in Insulin Degludec/Liraglutide (IDegLira) vs Basal–Bolus Therapy in Patients with Type 2 Diabetes: DUAL VII Trial (Abstract #124-LB)
About DUAL VII
DUAL VII was a phase 3b, 26-week, randomized, open-label, multicenter trial conducted in 12 countries with 506 patients.3 The trial was designed to investigate the efficacy and safety of Xultophy® 100/3.6 versus basal-bolus therapy in adults with type 2 diabetes previously treated with 20-50 units of insulin glargine U100 and metformin.3
About Xultophy® 100/3.6
Xultophy® 100/3.6 was approved by the US Food and Drug Administration on November 21, 2016 and is currently available in pharmacies nationwide. Xultophy® 100/3.6 is indicated as an adjunct to diet and exercise to improve glycemic 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).2 Xultophy® 100/3.6 is administered as a once-daily injection from a prefilled pen and can be taken with or without food. Each unit of Xultophy®100/3.6 contains 1 unit of insulin degludec U-100 and 0.036 mg of liraglutide.2 The starting dose of Xultophy®100/3.6 is 16 units (16 units insulin degludec and 0.58 mg liraglutide).2 The maximum dose of 50 units of Xultophy® 100/3.6 corresponds to 50 units of insulin degludec and 1.8 mg of liraglutide.2
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 (insulin degludec and liraglutide injection, 100 units/mL and 3.6 mg/mL) is safe and effective for use in children under 18 years of age.
Important Safety InformationWhat 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 (insulin degludec and liraglutide injection, 100 units/mL and 3.6 mg/mL) 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 Xultophy® 100/3.6 Prescribing Information, including Boxed Warning.