Novo Nordisk A/S Release: Results From SWITCH Trials For Tresiba Published In The Journal Of The American Medical Association
Plainsboro, NJ, July 3, 2017 – Novo Nordisk, a world leader in diabetes care, today announced that the results from the two phase 3b SWITCH trials were published in the Journal of American Medical Association (JAMA). The trials evaluated the efficacy and safety profile of Tresiba® (insulin degludec injection 100 U/mL), a once-daily, long-acting basal insulin, versus insulin glargine U-100 in adults with type 1 and type 2 diabetes.1,2
“Hypoglycemia is an important concern for adults with type 1 and type 2 diabetes who take insulin,” said Dr. Todd Hobbs, vice president and chief medical officer at Novo Nordisk US. “The publication of the results from the SWITCH trials provides important information about hypoglycemia that may help inform treatment decisions for adults with diabetes.”
SWITCH 1 and SWITCH 2 are the first completed double-blinded basal insulin trials to evaluate the hypoglycaemia rates/risks in patients taking Tresiba® and insulin glargine U-100 in type 1 diabetes and type 2 diabetes. The two phase 3b, 2x32-weeks randomized, double-blind, crossover, treat-to-target trials compared the efficacy and safety profile of Tresiba® with insulin glargine U-100. The primary endpoint studied was the rate of treatment emergent severe or blood glucose (BG) confirmed symptomatic hypoglycemic episodes during the maintenance period. The two secondary endpoints included: the rate of treatment emergent severe or BG confirmed nocturnal episodes and the proportion of subjects with one or more severe hypoglycemic episodes. In SWITCH 1, 501 people with type 1 diabetes were randomized to crossover treatment with Tresiba® and insulin glargine U-100 in combination with insulin aspart. In SWITCH 2, 721 people with type 2 diabetes were randomized to crossover treatment with Tresiba® and insulin glargine U-100 in combination with oral antidiabetic drugs.1,2
About Tresiba®
Tresiba® is a once-daily long-acting insulin indicated to improve glycemic control in patients 1 year of age and older with diabetes. Tresiba® is available in Novo Nordisk’s latest insulin delivery device – FlexTouch® – as a 100 units/mL or 200 units/mL pen.3 Tresiba® received its first regulatory approval in Japan in September 2012 and has since been approved in more than 80 countries globally. It 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
Important Safety Information
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 click here for Prescribing Information.
For more information about Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL), please visit Media.Tresiba.com.
About Novo Nordisk
Novo Nordisk is a global health care company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: hemophilia, growth disorders and obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has nearly 5,000 employees in the United States. For more information, visit novonordisk.us or follow us on Twitter: @novonordiskus.
For further information
Media:
Michael Bachner |
+1 609 664 7308 |
mzyb@novonordisk.com |
Investors: |
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Peter Hugreffe Ankersen |
+45 3075 9085 |
phak@novonordisk.com |
Hanna Ögren |
+45 3079 8519 |
haoe@novonordisk.com |
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Anders Mikkelsen |
+45 3079 4461 |
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Kasper Veje (US) |
+1 609 235 8567 |
References
- Lane W, Bailey TS, Gerety G, et al. Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients with Type 1 Diabetes: The SWITCH 1 Randomized Clinical Trial. Journal of the American Medical Association. Manuscript in press.
- Wysham C, Bhargava A, Chaykin L, et al. Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients with Type 2 Diabetes: The SWITCH 2 Randomized Clinical Trial. Journal of the American Medical Association. Manuscript in press.
- Tresiba [package insert]. Plainsboro, NJ: Novo Nordisk Inc; December 2016.
FlexTouch® and Tresiba® are registered trademarks of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2017 Novo Nordisk All rights reserved. USA17TSM01504 July 2017