Oral Semaglutide Demonstrated Significant Reduction in Blood Sugar vs Placebo in PIONEER 1 Trial

PR74102

ORLANDO, Florida, June 24, 2018 /PRNewswire=KYODO JBN/--

Oral semaglutide, an investigational GLP-1 analogue taken as a once-daily

tablet, achieved significant reductions in blood sugar versus placebo in adults

with type 2 diabetes, according to findings from the PIONEER 1 phase 3a trial.

The trial evaluated the efficacy and safety of 3, 7 and 14 mg oral semaglutide

compared with placebo as monotherapy over 26 weeks in adults with type 2

diabetes.1 The new data will be presented tomorrow, 24 June, 2018 at the

American Diabetes Association's 78th Scientific Sessions (ADA) in Orlando, US.

Two distinct approaches to evaluating the effects of oral semaglutide were

applied in the PIONEER 1 trial; a primary approach utilising an

intention-to-treat principle required by recent regulatory guidance, evaluating

the treatment effect including the effect of rescue medication and regardless

of premature trial product discontinuation; a secondary approach utilising an

on-treatment principle evaluated the treatment effect while on trial product

and without use of rescue medication.

Applying the intention-to-treat principle, the trial achieved its primary

objective by demonstrating that people treated with any of the three doses of

oral semaglutide achieved significant HbA1c reductions compared to placebo

(p<0.001 for all estimated treatment differences in HbA1c for oral semaglutide

vs placebo). Furthermore, people treated with 14 mg oral semaglutide achieved

significant reductions (p<0.001) in weight vs placebo while weight reductions

with 7 mg and 3 mg doses did not reach statistical significance.1

"Despite advancements in the diabetes treatment landscape, many people with

type 2 diabetes still struggle to reach their HbA1c target," said Vanita Aroda,

MD, associate director, diabetes clinical research, Brigham and Women's

Hospital, Boston, MA, U.S. "Based on the first results of PIONEER, I am

optimistic about the potential of having an oral GLP-1 receptor agonist that

may help patients achieve their HbA1c and blood sugar goals."

When applying the on-treatment principle, from a mean baseline HbA1c of 8.0%,

people treated with 3, 7 and 14 mg oral semaglutide achieved HbA1c reductions

of 0.8%, 1.3% and 1.5%, respectively, compared to 0.1% with placebo.1 In

addition, 59%, 72% and 80% of people, respectively, treated with oral

semaglutide achieved the ADA treatment target of HbA1c below 7% compared to 34%

treated with placebo.1   

Furthermore, when applying the on-treatment principle, people treated with 3, 7

and 14 mg oral semaglutide experienced a weight reduction of 1.7 kg, 2.5 kg and

4.1 kg, respectively, compared to 1.5 kg with placebo.1 Moreover, 21%, 29% and

44% of people treated with oral semaglutide achieved a weight reduction of 5%

or more compared to 16% with placebo.1

The most common adverse events (>5%) were mild or moderate nausea, which

occurred in 5-16% of people treated with oral semaglutide and diminished over

time, compared with 6% in those treated with placebo. Overall, adverse events

were reported by 58%, 53% and 57% of people treated with 3, 7 and 14 mg oral

semaglutide, respectively, and in 56% of people treated with placebo. Treatment

discontinuation due to adverse events ranged from 2% to 7% for people treated

with oral semaglutide, compared to 2% for people treated with placebo.1

About oral semaglutide      

Semaglutide is an analogue of human glucagon-like peptide-1 (GLP-1) that is

provided in tablet formulation with an absorption enhancer SNAC (sodium

N-(8-[2-hydroxybenzoyl] amino) caprylate).2 SNAC increases the bioavailability

of semaglutide, facilitating absorption of semaglutide from the stomach,

thereby enabling oral dosing.3 Oral semaglutide is in phase 3 development for

blood sugar control in adults with type 2 diabetes.

About PIONEER 1 and the PIONEER clinical trial programme

PIONEER 1 was a 26-week, randomised, double-blinded, placebo-controlled,

four-armed, parallel-group, multicentre, multinational trial comparing the

efficacy and safety of three dose levels of once-daily oral semaglutide vs

placebo in adults with type 2 diabetes treated with diet and exercise only.

PIONEER 1 randomized 703 people in a randomised 1:1:1:1 manner to receive

either a dose of oral semaglutide (3, 7 or 14 mg) or placebo once daily. The

primary endpoint was change in HbA1c from baseline at week 26. The proportion

of patients achieving HbA1c of <7% and change in body weight were secondary

endpoints.

The PIONEER phase 3a clinical development programme for oral semaglutide is a

global development programme with enrolment of 8,845 adults with type 2

diabetes across 10 clinical trials, which are all expected to complete in 2018.

About Novo Nordisk  

Novo Nordisk is a global healthcare company with 95 years of innovation and

leadership in diabetes care. This heritage has given us experience and

capabilities that also enable us to help people defeat obesity, haemophilia,

growth disorders and other serious chronic diseases. Headquartered in Denmark,

Novo Nordisk employs approximately 42,700 people in 79 countries and markets

its products in more than 170 countries.

For more information, visit: novonordisk.com,

Facebook: (http://www.facebook.com/novonordisk)

Twitter: (https://twitter.com/novonordisk)

LinkedIn: (https://www.linkedin.com/company/novo-norisk)

YouTube: (http://www.youtube.com/novonordisk).

References

1.    Aroda VR, Rosenstock J, Terauchi Y, et al. Effect And Safety Of Oral

Semaglutide Monotherapy In Type 2 Diabetes: PIONEER 1 Trial. Abstract 2-LB.

Presented at the 78th Scientific Sessions of the American Diabetes Association,

22-26 June 2018, Orlando, Florida, U.S. 2018.

2.    Lau J, Bloch P, Schäffer L, et al. Discovery of the Once-Weekly

Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide. Journal of Medicinal

Chemistry. 2015;58:7370-7380.

3.    Davies M, Pieber T, Hartoft-Nielsen M L, et al. Effect of Oral

Semaglutide Compared with Placebo and Subcutaneous Semaglutide on Glycaemic

Control in Patients with Type 2 Diabetes. JAMA. 2017;318:1460-1470.

Further information:

Media:

Katrine Sperling

+45-4442-6718

krsp@novonordisk.com;  

Asa Josefsson

+45-3079-7708

aajf@novonordisk.com

Michael Bachner(US),

+1-609-664-7308

mzyb@novonordisk.com  

Investors:

Peter Hugreffe Ankersen

+45-3075-9085

phak@novonordisk.com;

Anders Mikkelsen,

+45-3079-4461

armk@novonordisk.com  

Christina Kjaer

+45-3079-3009

cnje@novonordisk.com

Source: Novo Nordisk