Faster-acting insulin aspart showed a statistically significant reduction in HbA1c in type 1 diabetes and a comparable HbA1c reduction in type 2 diabetes versus NovoLog® (insulin aspart [rDNA origin] injection)

NEW ORLEANS, June 13, 2016 /PRNewswire/ --

Abstracts: 293-OR, 240-OR

Faster-acting insulin aspart improved postprandial glucose (PPG) control in type 1 and type 2 diabetes

New phase 3a findings showed that faster-acting insulin aspart demonstrated a statistically significant reduction in HbA_1c in type 1 diabetes, compared with NovoLog^® (insulin aspart [rDNA origin] injection),^[1] a comparable HbA_1c reduction in type 2 diabetes versus NovoLog^®[2] and improved post-meal or postprandial glucose (PPG) control in type 1 and type 2 diabetes.^[1],[2] Results from the onset 1 and onset 2 treat-to-target trials comparing faster-acting insulin aspart with NovoLog^® were presented at the 76^th annual Scientific Sessions of the American Diabetes Association (ADA) in New Orleans, U.S.

In onset 1, after 26 weeks of randomised therapy, faster-acting insulin aspart showed statistically significantly greater HbA_1c reduction versus NovoLog^® in adults with type 1 diabetes when dosed at mealtime ([95% confidence interval (CI)] -0.15 [-0.23; -0.07]). Faster-acting insulin aspart also showed comparable HbA_1c reduction when dosed 20 minutes after starting a meal, compared with NovoLog^® dosed at mealtime ([95% CI] 0.04 [-0.04; 0.12]).^[1]

Trial results for onset 1 also showed superior reduction in 2-hour PPG increment^* ([95% CI] -0.67 [-1.29; -0.04] mmol/L) versus NovoLog^®. The change in 1-hour PPG increment^*, a secondary supportive endpoint, was also reduced ([95% CI] -1.18 [-1.65; -0.71] mmol/L).^[1]

In onset 2, faster-acting insulin aspart demonstrated non-inferiority in HbA_1c reduction compared with NovoLog^® ([95% CI] -0.02 [-0.15; 0.10]) in adults with type 2 diabetes. Trial results could not confirm a statistically significant reduction in 2-hour PPG increment^* ([95% CI] -0.36 [-0.81; 0.08] mmol/L). However, a statistically significant reduction in 1-hour PPG increment^* was shown with faster-acting insulin aspart ([95% CI] -0.59 [-1.09; -0.09] mmol/L)^[2] which was a secondary supportive endpoint.

"We know that many people living with type 1 or type 2 diabetes may frequently struggle with spikes in blood glucose around mealtimes, resulting in post-meal hyperglycaemia," said Dr Bruce Bode, onset 1 and onset 2 investigator, Diabetes Specialist and Clinical Associate Professor of Medicine at Emory University School of Medicine, Atlanta, US. "The improvements in HbA_1c and postprandial glucose control we see with faster-acting insulin aspart in the data from the onset 1 and onset 2 trials are encouraging."

The most commonly reported adverse event with faster-acting insulin aspart in onset 1 and 2 was hypoglycaemia. However, there were no significant differences in the overall rate of severe or confirmed hypoglycaemia in people with type 1 and type 2 diabetes compared with NovoLog^®.^[1],[2]

Other common adverse events (≥5%) included nasopharyngitis, upper respiratory tract infection, urinary tract infection, headache, nausea, diarrhoea, wrong drug administration and back pain.^[3],[4]

Also presented during the scientific meeting were additional trial results assessing the pharmacokinetic (PK) and pharmacodynamic (PD) properties of faster-acting insulin aspart versus NovoLog^®:

• Results from a pooled analysis evaluating early exposure and glucose-lowering effect of faster-acting insulin aspart versus NovoLog^® in people with type 1 diabetes (Abstract 929-P).^[5]
• Results from a clinical study evaluating the early glucose-lowering effect with faster-acting insulin aspart (Abstract 969-P).^[6]

About the onset 1 and 2 trials    

The onset programme is a phase 3 clinical programme with faster-acting insulin aspart that consists of four trials encompassing more than 2,100 people with type 1 and type 2 diabetes.

The onset 1 trial (1,143 people randomised): a 26+26-week randomised, partially double-blind, basal-bolus, treat-to-target trial investigating faster-acting insulin aspart dosed at mealtime or 20 minutes after starting a meal compared with NovoLog^® dosed at mealtime, both in combination with a basal insulin in adults with type 1 diabetes. Only the data from the first 26 weeks were reported at the 76^th annual Scientific Sessions of the ADA. The primary endpoint was change from baseline HbA_1c versus NovoLog^®, and a secondary endpoint was change from baseline in 2-hour PPG increment^* versus NovoLog^®.

The onset 2 trial (689 people randomised): a 26-week randomised, double-blind, basal-bolus, treat-to-target trial investigating faster-acting insulin aspart compared with NovoLog^®, both dosed at mealtime and in combination with a basal insulin and metformin in adults with type 2 diabetes. The primary endpoint was change from baseline HbA_1c versus NovoLog^®, and a secondary endpoint was change from baseline in 2-hour PPG increment^* versus NovoLog^®.

About faster-acting insulin aspart
Faster-acting insulin aspart is an investigational mealtime (bolus) insulin developed by Novo Nordisk for improved blood glucose control in adults with type 1 and type 2 diabetes. Faster-acting insulin aspart is insulin aspart (NovoLog^®) in a new formulation in which two excipients have been added, a vitamin and an amino acid, to increase the initial absorption rate and foster an earlier blood glucose lowering effect. Novo Nordisk has submitted the regulatory filing for faster-acting insulin aspart in the United States and in the European Union.

About NovoLog^®(insulin aspart [rDNA origin] injection)   

What is NovoLog^®     

• NovoLog^® is a man-made insulin used to control high blood sugar in adults and children with diabetes mellitus.

* Postprandial glucose (PPG) increment is the increase in blood glucose levels after eating 

Important Safety Information for NovoLog^®     

Do not share your NovoLog^® FlexPen^®, NovoLog^® FlexTouch^®, PenFill^® cartridge or PenFill^® cartridge compatible insulin delivery device 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 NovoLog^® (insulin aspart [rDNA origin] injection)?    

Do not take NovoLog^® if:    

Please see next page for Important Safety Information.     

• your blood sugar is too low (hypoglycemia) or you are allergic to any of its ingredients.

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

• pregnant, plan to become pregnant, or are breastfeeding.
• taking new prescription or over-the-counter medicines, including supplements.

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

How should I take NovoLog^®?    

• Read the Instructions for Use and take exactly as directed.
• NovoLog^® is fast-acting. Eat a meal within 5 to 10 minutes after taking it.
• Know the type and strength of your insulin. Do not change your insulin type unless your health care provider tells you to.
• 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 other people a serious infection, or get a serious infection from them.

What should I avoid while taking NovoLog^®?    

• Do not drive or operate heavy machinery, until you know how NovoLog^® affects you.
• Do not drink alcohol or use medicines that contain alcohol.

What are the possible side effects of NovoLog^®?    

Serious side effects can lead to death, including:    

Low blood sugar. Some signs and symptoms include:

• anxiety, irritability, mood changes, dizziness, sweating, confusion, and headache.

Your insulin dose may need to change because of:    

• weight gain or loss, increased stress, illness, or change in diet or level of physical activity.

Other common side effects may include:    

• low potassium in your blood, injection site reactions, itching, rash, serious whole body allergic reactions, skin thickening or pits at the injection site, weight gain, and swelling of your hands and feet and if taken with thiazolidinediones (TZDs) possible heart failure.

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.

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]

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. Russell-Jones D, et al. Double-blind mealtime faster-acting insulin aspart vs insulin aspart in basal-bolus improves glycemic control in T1D: the onset^® 1 trial. Oral presentation at: 76^th Scientific Sessions of the American Diabetes Association (ADA). June 10-14, 2016; New Orleans, US.
2. Bowering K, et al. Faster-acting insulin aspart vs insulin aspart as part of basal-bolus therapy improves postprandial glycemic control in uncontrolled T2D in the double-blinded onset^® 2 trial. Oral presentation at: 76^th Scientific Sessions of the American Diabetes Association (ADA). June 10-14, 2016; New Orleans, US.
3. Data on file. Novo Nordisk A/S; Bagsværd.
4. Data on file. Novo Nordisk A/S; Bagsværd.
5. Heise T, et al. Faster onset and greater early exposure and glucose-lowering effect with faster-acting insulin aspart vs insulin aspart: a pooled analysis in subjects with type 1 diabetes. Poster presented at: 76^th Scientific Sessions of the American Diabetes Association (ADA). June 10-14, 2016; New Orleans, US.
6. Nosek L, et al. Greater early glucose-lowering effect of faster-acting insulin aspart is observed consistently from day to day. Poster presented at: 76^th Scientific Sessions of the American Diabetes Association (ADA). June 10-14, 2016; New Orleans, US.

NovoLog^®, FlexTouch^®, FlexPen^®, and PenFill^® are registered trademarks of Novo Nordisk A/S.

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

© 2016 Novo Nordisk         All rights reserved.          USA16FAM01713          June 2016

SOURCE Novo Nordisk