[ad_1]

Novo Nordisk A/S

Bagsværd, Denmark, 3 June 2022 – Novo Nordisk at the moment introduced headline outcomes from the principle phases of ONWARDS 1 (52 weeks) and ONWARDS 6 (26 weeks) part 3a trials with once-weekly insulin icodec.

ONWARDS 1 (insulin naïve folks with sort 2 diabetes)
ONWARDS 1 is a part 3a, 78-week efficacy and security treat-to-target trial investigating once-weekly insulin icodec vs insulin glargine U100 (insulin glargine), each together with non-insulin anti-diabetic remedy, in 984 insulin-naïve folks with sort 2 diabetes.

The trial achieved its major endpoint of demonstrating non-inferiority in lowering HbA1c at week 52 with insulin icodec in comparison with insulin glargine.

From an general baseline HbA1c of 8.5% once-weekly insulin icodec achieved a superior discount in estimated HbA1c of -1.55% in comparison with -1.35% for insulin glargine (estimated remedy distinction: -0.19%). Superior time in vary (TIR) was additionally achieved for once-weekly insulin icodec in comparison with insulin glargine.

In the trial, there was no statistically vital distinction in estimated charges of extreme or clinically vital hypoglycaemia (blood glucose beneath 3mmol/L) with 0.30 occasions per affected person yr uncovered to once-weekly insulin icodec and 0.16 occasions per patient-year uncovered to insulin glargine. In the trial, once-weekly insulin icodec appeared to have a protected and well-tolerated profile.

ONWARDS 6 (basal-bolus remedy in folks with sort 1 diabetes)
ONWARDS 6 is a part 3a, 52-week efficacy and security treat-to-target trial investigating once-weekly insulin icodec vs insulin degludec, each together with three day by day mealtime insulin injections, in 582 folks with sort 1 diabetes.

The trial achieved its major endpoint of demonstrating non-inferiority in lowering HbA1c at week 26 with insulin icodec in comparison with insulin degludec.

From an general baseline HbA1c of seven.6%, once-weekly insulin icodec achieved a discount in estimated HbA1c of -0.47% in comparison with -0.51% for insulin degludec (estimated remedy distinction: 0.05%).

Story continues

In the trial, there was a statistically vital greater estimated price of extreme or clinically vital hypoglycaemia (blood glucose beneath 3 mmol/L) with 19.93 occasions per affected person yr uncovered to once-weekly insulin icodec and 10.37 occasions per patient-year uncovered to insulin degludec. In the trial, once-weekly insulin icodec appeared to have a protected and well-tolerated profile.

“The outcomes of the principle part of ONWARDS 1 verify the robust outcomes seen in ONWARDS 2 and strengthen the profile of once-weekly insulin icodec which has the potential to grow to be the best insulin for folks with sort 2 diabetes initiating insulin remedy”, says Martin Holst Lange, government vice chairman for Development at Novo Nordisk. “The outcomes of the principle part of ONWARDS 6 mirror the complexity of introducing a once-weekly insulin in basal bolus remedy for folks with sort 1 diabetes. Novo Nordisk stays assured that once-weekly insulin icodec holds the potential to grow to be a protected and efficacious remedy in sort 1 diabetes.”

About the ONWARDS medical programme
The ONWARDS medical growth programme for once-weekly insulin icodec at the moment contains six part 3a international medical trials, together with a trial with real-world components, involving greater than 4,000 adults with sort 1 or sort 2 diabetes.

ONWARDS 1 is a 78-week trial evaluating the efficacy and security of once-weekly insulin icodec with once-daily insulin glargine U100 each together with non-insulin anti-diabetic remedy in 984 insulin-naïve folks with sort 2 diabetes. Following the completion of the principle part of the trial, a 26-week extension part is ongoing.

ONWARDS 2 was a part 3a, 26-week efficacy and security treat-to-target trial investigating once-weekly insulin icodec vs insulin degludec in 526 folks with sort 2 diabetes switching from a once-daily insulin. The outcomes have been reported on 28 April 2022.

ONWARDS 3 is a 26-week trial evaluating once-weekly insulin icodec with once-daily insulin degludec. The goal of the trial is to evaluate the efficacy and security of insulin icodec in 588 insulin-naïve folks with sort 2 diabetes.

ONWARDS 4 is a 26-week trial evaluating once-weekly insulin icodec with once-daily insulin degludec, each together with mealtime insulin. The goal of the trial is to evaluate the efficacy and security of insulin icodec in 582 folks with sort 2 diabetes handled with basal and bolus insulin.

ONWARDS 5 is a 52-week trial evaluating once-weekly insulin icodec with once-daily basal insulin. The goal of the trial is to evaluate the effectiveness and security of insulin icodec, with an app offering dosing suggestion, in 1085 insulin-naïve folks with sort 2 diabetes in a medical follow setting.

ONWARDS 6 is a 52-week trial evaluating once-weekly insulin icodec with once-daily insulin degludec, each together with mealtime insulin. The goal of the trial is to evaluate the efficacy and security of insulin icodec in 583 folks with sort 1 diabetes. Following the completion of the principle part of the trial, a 26-week extension part is ongoing.

About Novo Nordisk
Novo Nordisk is a number one international healthcare firm, based in 1923 and headquartered in Denmark. Our function is to drive change to defeat diabetes and different severe persistent ailments comparable to weight problems and uncommon blood and endocrine issues. We accomplish that by pioneering scientific breakthroughs, increasing entry to our medicines, and dealing to stop and in the end treatment illness. Novo Nordisk employs about 49,300 folks in 80 nations and markets its merchandise in round 170 nations. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For extra data, go to novonordisk.com, Facebook, Twitter, LinkedIn and YouTube

Further data

Company announcement No 49 / 2022

 

Attachment

[ad_2]

Source link

#Novo #Nordisk #achieves #major #targets #ONWARDS #trials #onceweekly #insulin #icodec #demonstrating #superior #discount #HbA1c #insulin #glargine #U100 #ONWARDS

By Seth A. Dunbar

Seth Dunbar leads clinical research study operations and quality & compliance. He is experienced working with teams to help drug sponsors better leverage eSource data. With 10+ years of experience Seth brings expertise developing eClinical services that integrate data and technology to help companies optimise study execution.

Leave a Reply

Your email address will not be published.