Tresiba® (insulin degludec injection U-100) demonstrated significantly lower rates of overall, nocturnal and severe hypoglycaemia vs insulin glargine U-100

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Jun 11, 2016, 11:00 ET

NEW ORLEANS, June 11, 2016 /PRNewswire/ --

Poster #87-LB; #90-LB

New findings from the two phase 3b SWITCH trials showed that treatment with long-acting basal insulin Tresiba^® (insulin degludec injection U-100) resulted in significantly lower rates of overall, nocturnal and severe hypoglycaemia compared with insulin glargine U-100.^[1],[2] Results from the SWITCH 1 and 2 trials, the first completed double-blinded basal insulin studies evaluating the safety profile and efficacy of Tresiba^® versus insulin glargine U-100,^[1],[2] were presented today at the American Diabetes Association 76^th Scientific Sessions in New Orleans, U.S.

In SWITCH 1, patients with type 1 diabetes taking Tresiba^® compared with insulin glargine U-100 experienced: a rate reduction of 11% in overall symptomatic blood glucose (BG) confirmed hypoglycaemic episodes (95% confidence interval [CI]: 0.85; 0.94); a rate reduction of 36% in nocturnal BG confirmed symptomatic hypoglycaemic episodes (95% CI: 0.56; 0.73), and a rate reduction of 35% severe or BG confirmed symptomatic hypoglycaemia (95% CI: 0.48; 0.89); during the maintenance period.^[1] All of the above analyses showed similar results in the full treatment period.

In SWITCH 2, patients with type 2 diabetes taking Tresiba^® compared with insulin glargine U-100 experienced a rate reduction of 30% in overall BG confirmed symptomatic hypoglycaemic episodes (95% CI: 0.61; 0.80) and a rate reduction of 42% in nocturnal BG confirmed symptomatic hypoglycaemic episodes (95% CI: 0.46; 0.74). The above analyses showed significant results in the full treatment period. In the maintenance period, there was a trend towards lower rates of severe hypoglycaemia in favour of IDeg U-100 vs IGlar U-100. In the full treatment period, a significant 51% rate reduction in severe hypoglycaemia was observed in patients receiving IDeg U-100 vs IGlar U-100 (95% CI: 0.26; 0.94).^[2]

"Hypoglycaemia is an ongoing challenge for people with type 1 and type 2 diabetes," said Dr. Wendy Lane, lead SWITCH 1 study investigator and clinical endocrinologist at Mountain Diabetes and Endocrine Center in Asheville, N.C., U.S. "These findings are important for the diabetes community, and add to the existing body of evidence for Tresiba^®."

Tresiba^® (insulin degludec injection U-100) was noninferior to insulin glargine U-100 in reducing HbA_1c in both treatment periods for both SWITCH 1 and 2 trials.^[1]-[3] (SWITCH 1 treatment period 1: IDeg 6.92% vs IGlar U-100 6.78%; SWITCH 1 treatment period 2: IDeg 6.95% vs IGlar U-100 6.97%; SWITCH 2 treatment period 1: IDeg 7.06% vs IGlar U-100 6.98%; SWITCH 2 treatment period 2: IDeg 7.08% vs IGlar U-100 7.11%).^[1]-[3] The end-of-trial insulin doses were similar at the end of each treatment period in both trials. The most common adverse events (≥5%) included nasopharyngitis, upper respiratory tract infections and hypoglycemia.^[1]-[3]

About SWITCH 1 and 2

The two phase 3b, 2x32-weeks randomised, double-blind, crossover, treat-to-target trials were initiated in January 2014 to compare the safety profile and efficacy of Tresiba^® and insulin glargine U-100. The overall objective was to document the hypoglycaemia profile in type 1 diabetes and type 2 diabetes, respectively. During the maintenance period, the primary endpoint studied was the number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. The two secondary endpoints included: the number of treatment emergent severe or BG confirmed nocturnal episodes and the proportion of subjects with one or more severe hypoglycaemic episodes. In SWITCH 1, 501 people with type 1 diabetes were randomised 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 randomised to crossover treatment with Tresiba^® and insulin glargine U-100 in combination with oral antidiabetic drugs.^[1],[2]

About Hypoglycaemia

Hypoglycaemia is a frequent complication in people with type 1 and type 2 diabetes when low levels of blood glucose in the blood deprive muscles, cells and the brain of the energy needed to function.^[4] Hypoglycaemia can be triggered by multiple factors including taking too much insulin, not following the prescribed meal schedule or participating in unusually strenuous or prolonged exercise.

About Tresiba^®

Tresiba^® is a long-acting insulin that lasts at least 42 hours after the last of eight once-daily injections (0.4 units/kg), and has a consistently flat and stable profile at steady state.^[5]-[7] Tresiba^® is taken once daily, at any time of day. Patients who miss or are delayed in taking their dose of Tresiba^® should take their dose as soon as they remember, then continue with their regular dosing schedule, making sure there are at least eight hours between doses.^[5] Tresiba^® is available in Novo Nordisk's latest insulin delivery device - FlexTouch^® - as a 100 units/mL or 200 units/mL pen. Tresiba^® U-200 FlexTouch^® can dose up to 160 units in a single injection.^[5] FlexTouch^® is also the only prefilled insulin pen with no push-button extension.^[5] Tresiba^® (insulin degludec injection U-100) received its first regulatory approval in September 2012 and has since been approved in more than 60 countries globally. It was most recently approved by the FDA in the United States on September 25, 2015.

What is Tresiba^® (insulin degludec injection U-100)?

Prescription Tresiba^® is a long-acting insulin used to control high blood sugar in adults with diabetes
Tresiba^® is not for people with diabetic ketoacidosis
Tresiba^® is available in 2 concentrations: 200 units/mL and 100 units/mL
It is not known if Tresiba^® is safe and effective in children under 18 years of age

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
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
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

Important Safety Information (cont'd)

How should I take Tresiba^®? (cont'd)

Never inject Tresiba^® (insulin degludec injection U-100) 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.

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 41,600 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk-us.com or follow us on

Twitter: @novonordiskus.

Further information
Media:
Katrine Sperling
+45-4442-6718
[email protected]

Åsa Josefsson
+45-3079-7708
[email protected]

Michael Bachner (U.S.)
+1-609-664-7308
[email protected]

Investors:
Peter Hugreffe Ankersen
+45-3075-9085
[email protected]

Melanie Raouzeos
+45-3075-3479
[email protected]

Kasper Veje (U.S.)
+1-609-235-8567
[email protected]

References

1. Lane W, Bailey T, Gerety G, et al. SWITCH 1: Reduced Hypoglycaemia With Insulin Degludec (IDeg) vs Insulin Glargine (IGlar), both U100, in Patients With T1D at High Risk of Hypoglycaemia: A Randomised, Double-Blind Crossover Trial. Abstract 87-LB presented at the 76th Annual Scientific Sessions of the American Diabetes Association (ADA), New Orleans, USA. 11 June 2016.

2. Wysham C, Bhargava A, Chaykin L, et al. SWITCH 2: Reduced Hypoglycaemia With Insulin Degludec (IDeg) vs Insulin Glargine (IGlar), both U100, in Patients With T2D at High Risk of Hypoglycaemia: A Randomised, Double-Blind Crossover Trial. Abstract 90-LB presented at the the 76^th Annual Scientific Sessions of the American Diabetes Association (ADA), New Orleans, USA; 11 June 2016.

3. Novo Nordisk. Data on file.

4. Willis WD, Diago-Cabezudo JI, Madec-Hily A, Aslam A. Medical resource use, disturbance of daily life and burden of hypoglycemia in insulin-treated patients with diabetes: results from a European online survey. Expert Review of Pharmacoeconomics & Outcomes Research. 2013; 13:123-30.

5. Tresiba [package insert]. Plainsboro, NJ: Novo Nordisk Inc; September 2015.

6. Heise T, Hermanski L, Nosek L, Feldman A, Rasmussen S, Haahr H. Diabetes Obes Metab. 2012;14(9):859-864.

7. Heise T, Korsatko S, Nosek L, et al. J Diabetes. 2016;8(1):132-138.

FlexTouch^® and Tresiba^® are registered trademarks of Novo Nordisk A/S.

Novo Nordisk is a registered trademark of Novo Nordisk A/S.

SOURCE Novo Nordisk