Tresiba® demonstrated significantly lower A1C and rates of hypoglycaemia versus insulin glargine U-300 in real-world evidence study

ORLANDO, Fla., June 23, 2018 /PRNewswire/ -- Findings from CONFIRM – a large, retrospective real-world evidence (RWE) study comparing the effectiveness of Tresiba^® (insulin degludec injection) 100 U/mL, 200 U/mL versus insulin glargine U-300 in more than 4,000 adults with type 2 diabetes who were starting basal insulin for the first time showed that after six months those treated with Tresiba^® had significantly lower A1C compared to those treated with insulin glargine U-300 (-1.5% vs -1.2% respectively; p=0.029).¹ The full results will be presented on Monday, June 25 at the American Diabetes Association's 78^th Scientific Sessions (ADA) in Orlando, Fla.

As a secondary endpoint, there was a 30% lower rate of hypoglycaemic episodes with Tresiba^® compared to insulin glargine U-300 (p=0.045).¹ In this study, hypoglycaemic events were registered using the International Classification of Diseases (ICD) codes 9/10 following diagnosis from a health care provider.²

This real-world study also showed in another secondary endpoint that people treated with Tresiba^® were more likely to stay on their treatment. Those treated with insulin glargine U-300 had a 37% higher rate of discontinuing treatment after two years (p<0.001).¹

"Real-world studies, such as CONFIRM, are important to understand how clinical trials may translate to patients in everyday clinical practice," said Todd Hobbs, vice president and US chief medical officer of Novo Nordisk. "One of the most feared complications for people living with diabetes is hypoglycaemia, and the CONFIRM results add to the body of evidence on Tresiba^® for adults with type 2 diabetes."

About the CONFIRM study
The CONFIRM study is a retrospective, non-interventional comparative effectiveness study that investigated Tresiba^® and insulin glargine U-300 (Toujeo^®) in 4,056 insulin-naïve (defined as no evidence of basal insulin use at least 365 days prior to index date) adults with type 2 diabetes in the US. Study groups were equal in size (n = 2,028) and patients in each group were comparable after matching for baseline characteristics. Patients were uncontrolled on one or more oral antidiabetic drugs or a GLP-1 (glucagon-like peptide-1 receptor agonist) and prescribed Tresiba^® or insulin glargine U-300 according to local practice. Electronic health records were sourced from multiple health systems in the US. The primary endpoint was change in A1C (blood sugar control) from baseline to six months follow-up. Secondary endpoints included rate of hypoglycaemia, proportion of patients with at least one hypoglycaemia episode and the rate of treatment discontinuation.

As with all real-world studies, CONFIRM was not randomized and it carries the limitations of real-world evidence. This includes potential underreporting of hypoglycaemia (however, this is the case in both treatment arms in CONFIRM meaning that the rate ratio as well as the odds ratio is expected to be preserved); the short follow-up period of 3-6 months (though corresponds to when the largest changes in A1C tend to occur and is commonly used in many trials). Additionally, in CONFIRM, there is only insight into evidence of prescribed basal insulin and not actual use.

About hypoglycaemia
Hypoglycaemia occurs when blood sugar levels are too low and cannot provide the body's organs with the energy they need. Hypoglycaemia can cause a range of symptoms including confusion, trembling, sweating, increased heart rate, difficulty with concentration and speech and in severe cases can lead to a seizure or coma.^3-6

About Tresiba^®
Tresiba^® is a long-acting insulin approved for type 1 and type 2 diabetes in children as young as 1 year of age. Once-daily Tresiba^® is available in Novo Nordisk's insulin delivery device – FlexTouch^®, a 100 units/mL or 200 units/mL pen. Tresiba^® U-100 FlexTouch^® can deliver up to 80 units of insulin in a single injection. Tresiba^® U-200 FlexTouch^® can dose up to 160 units in a single injection.

Tresiba^® was approved by the FDA in the United States on September 25, 2015.

What is Tresiba^®?

• Prescription Tresiba^® is a long-acting insulin used to control high blood sugar in adults and children who are 1 year of age and older with diabetes
• Tresiba^® is not for people with diabetic ketoacidosis
• Tresiba^® is not for children who need less than 5 units of Tresiba^® each day
• It is not known if Tresiba^® is safe and effective in children under 1 year of age
• Tresiba^® is available in 2 concentrations: 200 units/mL and 100 units/mL

Do not share your Tresiba^® FlexTouch^® 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.

Who should not take Tresiba^®?
Do not take Tresiba^® if you:

• are having an episode of low blood sugar
• are allergic to Tresiba^® or any of the ingredients in Tresiba^®

Before taking Tresiba^®, tell your health care provider about all your medical conditions, including if you are:

• pregnant, planning to become pregnant, or are breastfeeding
• taking new prescription or over-the-counter medicines, vitamins, or herbal supplements

Talk to your health care provider about low blood sugar and how to manage it.

How should I take Tresiba^®?

• Read the Instructions for Use and take Tresiba^® exactly as your health care provider tells you to
• Do not do any conversion of your dose. The dose counter always shows the selected dose in units
• Know the type and strength of insulin you take. Do not change the type of insulin you take unless your health care provider tells you to
• Adults - If you miss or are delayed in taking your dose of Tresiba^®:
• Take your dose as soon as you remember, then continue with your regular dosing schedule
• Make sure there are at least 8 hours between doses
• If children miss a dose of Tresiba^®:
• Call the healthcare provider for information and instructions about checking blood sugar levels more often until the next scheduled dose of Tresiba^®
• Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them
• Do not reuse or share your needles with other people. You may give them a serious infection, or get a serious infection from them
• Never inject Tresiba^® into a vein or muscle
• Never use a syringe to remove Tresiba^® from the FlexTouch^® pen

What should I avoid while taking Tresiba^®?

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

What are the possible side effects of Tresiba^®?
Tresiba^® may cause serious side effects that can be life-threatening, including:

• Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include anxiety, irritability, mood changes, dizziness, sweating, confusion, and headache
• Low potassium in your blood (hypokalemia)
• Heart failure in some people if taken with thiazolidinediones (TZDs). 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 TZDs with Tresiba^®. 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

Your insulin dose may need to change because of change in level of physical activity or exercise, increased stress, change in diet, weight gain or loss, or illness.

Common side effects may include reactions at the injection site, itching, rash, serious allergic reactions (whole body reactions), skin thickening or pits at the injection site (lipodystrophy), weight gain, and swelling of your hands and feet.

Get emergency medical help if you have trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion.

Please see Prescribing Information for Tresiba^® at http://www.novo-pi.com/tresiba.pdf.

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. Tibaldi J, Haldrup S, Sandberg V, et al. Clinical Outcome Assessment of the Effectiveness of Insulin Degludec (Degludec) in Real-life Medical Practice (CONFIRM): A Comparative Effectiveness Study of Degludec and Insulin Glargine 300U/mL (Glargine U300) in 4,056 Insulin-Naïve Patients with Type 2 Diabetes (T2D) Oral/poster presentation. 78^th Annual Scientific Sessions of the American Diabetes Association (ADA), Orlando, Florida, US. June 2018.
2. Ginde AA, Blanc PG, Lieberman RM, et al. Validation of ICD-9-CM coding algorithm for improved identification of hypoglycemia visits. BMC Endocr Disord. 2008;8:4.
3. Seaquist ER, Anderson J, Childs B, et al. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care. 2013;36:1384-1395.
4. International Hypoglycaemia Study Group. Diagnosis of hypoglycaemia. Available online at http://ihsgonline.com/understanding-hypoglycaemia/diagnosis. Last accessed: June 2018.
5. Cryer PE. Hypoglycemia, functional brain failure, and brain death. J Clin Invest. 2007;117:868-870.
6. Ahrén B. Avoiding hypoglycemia: a key to success for glucose-lowering therapy in type 2 diabetes. Vasc Health Risk Manag. 2013;9:155-163.

Tresiba^® and FlexTouch^® are registered trademarks of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
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© 2018 Novo Nordisk         All rights reserved.         USA18TSM01286       June 2018

SOURCE Novo Nordisk