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MarketScreener Homepage  >  Equities  >  NASDAQ OMX COPENHAGEN  >  Novo Nordisk A/S    NOVO B   DK0060534915

NOVO NORDISK A/S

(NOVO B)
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Novo Nordisk A/S : Once-weekly semaglutide 2.0 mg demonstrates superior reduction in HbA1c vs once-weekly semaglutide 1.0 mg in people with type 2 diabetes in the SUSTAIN FORTE trial

11/17/2020 | 09:25am EST

Bagsværd, Denmark, 17 November 2020 - Novo Nordisk today announced headline results from the SUSTAIN FORTE trial, a phase 3b 40-week, efficacy and safety trial with once-weekly semaglutide 2.0 mg vs once-weekly semaglutide 1.0 mg as add-on to metformin and/or sulfonylureas in 961 people with type 2 diabetes in need for treatment intensification. The trial achieved its primary endpoint by demonstrating a statistically significant and superior reduction in HbA1c at week 40 with semaglutide 2.0 mg compared to semaglutide 1.0 mg.

When evaluating the effects of treatment taken as intended1 and from a high mean baseline HbA1c of 8.9%, people treated with semaglutide 2.0 mg achieved a statistically significant and superior reduction in HbA1c of 2.2% compared with a reduction of 1.9% with semaglutide 1.0 mg at week 40. The American Diabetes Association (ADA) treatment target of HbA1c below 7.0% was achieved by 68% of people treated with semaglutide 2.0 mg vs 58% on semaglutide 1.0 mg.

From a mean baseline body weight of 99.3 kg, people treated with semaglutide 2.0 mg experienced a statistically significant1 and superior weight loss of 6.9 kg compared with 6.0 kg with semaglutide 1.0 mg.

When applying the treatment policy estimand2, people treated with semaglutide 2.0 mg experienced a reduction in HbA1c of 2.1% compared to 1.9% for people treated with 1.0 mg dose at week 40. People treated with semaglutide 2.0 mg experienced a statistically non-significant weight loss of 6.4 kg compared with 5.6 kg with semaglutide 1.0 mg.

 Trial product estimand[1]Treatment policy estimand2
Once-weekly semaglutide2.0 mg1.0 mg2.0 mg1.0 mg
HbA1c reduction2.2%*1.9%2.1%*1.9%
Body weight reduction6.9 kg*6.0 kg6.4 kg5.6 kg

*Statistically significant vs once-weekly semaglutide 1.0 mg

In the trial, both doses of semaglutide appeared safe and well-tolerated. The most common adverse events were gastrointestinal, the vast majority were mild to moderate and diminished over time and were consistent with the GLP-1 receptor agonist class. Compared to semaglutide 1.0 mg, the gastrointestinal adverse events were similar for semaglutide 2.0 mg with nausea rates around 15% for both doses. The treatment discontinuation rates due to adverse events were similar and below 5% for both doses of semaglutide.

“We are very pleased with the results from the SUSTAIN FORTE trial with the large HbA1c reduction from a high baseline as well as the safety and tolerability profile, which establish a attractive benefit-risk ratio for treatment of type 2 diabetes with semaglutide” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk. “Semaglutide 1.0 mg has across the SUSTAIN programme demonstrated that up to 80% of patients achieved HbA1c levels below 7%. This study demonstrates that patients in poor glycaemic control increase the likelihood of achieving their HbA1c target when treated with semaglutide 2.0 mg.”

About the SUSTAIN clinical programme
The SUSTAIN clinical development programme for once-weekly subcutaneous semaglutide injection currently comprises 11 phase 3 global clinical trials, including a cardiovascular outcomes trial, involving more than 11,000 adults with type 2 diabetes in total. Semaglutide 1.0 mg is approved under the brand name Ozempic® indicated for type 2 diabetes.

About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 44,000 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.

Further information

Media:  
Mette Kruse Danielsen+45 3079 8883mkd@novonordisk.com
Ken Inchausti (US)+1 609 240 9429kiau@novonordisk.com
   
Investors:  
Daniel Muusmann Bohsen+45 3075 2175dabo@novonordisk.com
Valdemar Borum Svarrer+45 3079 0301jvls@novonordisk.com
Ann Søndermølle Rendbæk+45 3075 2253arnd@novonordisk.com
Mark Joseph Root+45 3079 4211mjhr@novonordisk.com
Kristoffer Due Berg (US)+1 609 235 2989krdb@novonordisk.com

Company announcement No 71 / 2020

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1 Based on the trial product estimand: treatment effect if all people adhered to treatment and did not initiate other type 2 diabetes therapies

2 Based on the treatment policy estimand: treatment effect regardless of treatment adherence or initiation of other type 2 diabetes therapies


Attachment

  • PR201117_SUSTAIN_FORTE

© OMX, source OMX

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Financials
Sales 2020 127 B 20 674 M 20 674 M
Net income 2020 42 017 M 6 839 M 6 839 M
Net cash 2020 9 589 M 1 561 M 1 561 M
P/E ratio 2020 24,9x
Yield 2020 2,00%
Capitalization 1 036 B 169 B 169 B
EV / Sales 2020 8,08x
EV / Sales 2021 7,72x
Nbr of Employees 44 326
Free-Float 75,1%
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Mean consensus HOLD
Number of Analysts 28
Average target price 456,33 DKK
Last Close Price 448,10 DKK
Spread / Highest target 22,7%
Spread / Average Target 1,84%
Spread / Lowest Target -31,9%
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Managers and Directors
NameTitle
Lars Fruergaard Jørgensen President & Chief Executive Officer
Helge Lund Chairman
Maziar Mike Doustdar Executive Vice President-International Operations
Karsten Munk Knudsen Chief Financial Officer & Executive Vice President
Mads Krogsgaard Thomsen Chief Science Officer & Executive Vice President
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