SAN DIEGO, June 12, 2017 /PRNewswire/ -- Novo Nordisk today announced the primary results from DEVOTE – the first randomised, double-blind, treat-to-target, event-driven trial comparing two basal insulins, Tresiba® (insulin degludec injection 100 U/mL) and insulin glargine U100, in adults with type 2 diabetes at high risk of cardiovascular (CV) disease. The trial demonstrated that Tresiba® met the primary endpoint of non-inferiority compared with insulin glargine U100 for major adverse CV events (MACE) with a hazard ratio (HR) of 0.91 (95% confidence interval [CI]: 0.78; 1.06, p=0.209). Additionally, the findings for each component of MACE were consistent with the overall endpoint, including first occurrence of CV death (HR=0.96, 95% CI: 0.76; 1.21, p=0.714), non-fatal myocardial infarction (HR=0.85, 95% CI: 0.68; 1.06, p=0.150) or non-fatal stroke (HR=0.90, 95% CI: 0.65; 1.23, p=0.502).1
Results from the trial, involving 7,637 people with type 2 diabetes followed for approximately two years, were presented at the American Diabetes Association's 77th Scientific Sessions (ADA 2017) and also published simultaneously in the New England Journal of Medicine.1
Results from the secondary endpoints of the trial showed a significant reduction in the rate of severe (40%) and nocturnal severe (53%) hypoglycaemia with Tresiba® vs. insulin glargine U100 (p<0.001).* Additionally, post hoc analyses showed: similar levels of glycaemic control with an end of trial A1C estimated treatment difference of 0.01%, (p=0.779) between the two treatment groups and significantly lower fasting plasma glucose levels with Tresiba® after 2 years vs. insulin glargine U100 (estimated treatment difference –7.2 mg/dL, p<0.001).1
"In the DEVOTE trial degludec demonstrated no increase in the risk of major cardiovascular events and significant reductions in the rates of severe and nocturnal severe hypoglycaemia compared to insulin glargine U100," said Dr Bernard Zinman of the Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Canada and member of the DEVOTE Steering Committee. "Risk of cardiovascular disease and hypoglycaemia are important concerns for those with type 2 diabetes and the results from DEVOTE add to the mounting evidence that will play an important role in treatment decisions."
The safety profile of Tresiba® in DEVOTE was generally consistent with previous Tresiba® clinical trials.1 In DEVOTE, systematic collection of adverse events was limited to serious adverse events, adverse events leading to permanent discontinuation of investigational product (5.2% of patients in the degludec arm and 5.8% of patients in the glargine U100 arm), medication errors leading to serious adverse events and adverse events related to technical complaints.
*Severe hypoglycaemia was defined as an episode requiring assistance of another person, and nocturnal severe defined as between the hours of 00:01–05:59, inclusive.1
DEVOTE is a long-term, multi-national, randomised, double-blinded, and event-driven trial conducted to confirm the CV safety of Tresiba® (insulin degludec) compared to insulin glargine U100. In the trial, 7,637 people (Tresiba®: n=3,818, insulin glargine: n=3,819) with type 2 diabetes at high risk of CV disease were randomised to treatment with either Tresiba® or insulin glargine U100 in vial in addition to standard of care.
The primary endpoint in DEVOTE was time from randomisation to the first occurrence of a three component composite cardiovascular outcome comprising cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. Secondary endpoints included severe hypoglycaemia, nocturnal severe hypoglycaemia, A1C and fasting plasma glucose.
Tresiba® is a once-daily long-acting insulin indicated to improve glycaemic 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.2 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 healthcare 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: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 42,000 people in 77 countries and markets its products in more than 165 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube
- Cardiovascular Safety of Insulin Degludec vs. Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE) Trial Results. Symposium 3-CT-SY22 at the 77th Scientific Sessions of the American Diabetes Association (ADA). 12 June 2017. Manuscript in press.
- Tresiba [package insert]. Plainsboro, NJ: Novo Nordisk Inc; December 2016.
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SOURCE Novo Nordisk