More People Treated With Once-weekly Semaglutide Achieved Reductions in Both Glucose and Weight vs. Comparator Treatments

PR70006

LISBON, Sep. 12, 2017 / PRNewswire=KYODO JBN/ -

Poster # 820

A post-hoc analysis of the SUSTAIN 1-5 trials demonstrated that a greater

proportion of adults with type 2 diabetes achieved a clinically meaningful

reduction in both HbA1c and body weight with once-weekly semaglutide vs.

comparator treatments. Comparators included placebo, sitagliptin, insulin

glargine U100 or exenatide extended release (ER). The analysis was presented

today at the 53rd Annual Meeting of the European Association For The Study Of

Diabetes.[1]

"As a physician, helping patients with type 2 diabetes achieve glycaemic and

weight loss targets can be challenging," said Dr Helena Rodbard, SUSTAIN 5

investigator and medical director at Endocrine and Metabolic Consultants,

Rockville, Maryland. "The meaningful reductions demonstrated with semaglutide

in both glucose and body weight are encouraging, as more treatment strategies

are needed to help meet this challenge."

Significantly more people treated with once-weekly semaglutide achieved the

clinically meaningful composite endpoint of >=1% HbA1c reduction and >=5%

weight loss with 0.5 mg (25-35%) and 1.0 mg (38-56%) semaglutide vs. all

comparators (2-13%; p<0.0001) in SUSTAIN 1-5.[1]

In addition, more people achieved the composite endpoint with once-weekly

semaglutide 1.0 mg compared with semaglutide 0.5 mg (p<0.0001 for SUSTAIN 2, 4

and 5; p=0.17 for SUSTAIN 1).[1]

In this post-hoc analysis, semaglutide was well tolerated, with a safety

profile similar to that of other glucagon-like peptide-1 receptor agonists. The

most common adverse event with semaglutide was nausea. In SUSTAIN 1-4, severe

or blood glucose confirmed symptomatic hypoglycaemia events were fewer or

similar with once-weekly semaglutide vs. comparators. In SUSTAIN 5, on a

background of basal insulin, more events were observed with once-weekly

semaglutide than with placebo.[1]

About semaglutide

Semaglutide is a once-weekly analogue of human glucagon-like peptide-1 (GLP-1)

that stimulates insulin and suppresses glucagon secretion in a

glucose-dependent manner, while decreasing appetite and food intake.[2]-[5]

Once-weekly semaglutide is currently under review by seven regulatory agencies,

including the US Food and Drug Administration (FDA), the European Medicines

Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

About the SUSTAIN clinical trial programme

SUSTAIN (Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes)

is a clinical trial programme for semaglutide, administered once weekly, that

comprises seven phase 3a global clinical trials and a cardiovascular outcomes

trial, involving more than 8,000 adults with type 2 diabetes.

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 41,400 people in

77 countries and markets its products in more than 165 countries. For more

information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube  

Novo Nordisk A/S

Corporate Affairs     

Novo Alle

2880 Bagsværd

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CVR no: 24 25 67 90

References

1. Rodbard H, Bellary S, Hramiak I, et al. Responder analysis of subjects

achieving HbA1c >=1% and weight loss >=5% across SUSTAIN 1-5 clinical trials.

Poster 802. 53rd Annual Meeting of the European Association For The Study Of

Diabetes (EASD), Lisbon, Portugal; 11-15 September 2017.

2. Korsatko A, Brunner M, Sach-Friedl S, et al. Effect of once-weekly

semaglutide on the counter-regulatory response to hypoglycaemia in subjects

with type 2 diabetes. Abstract 764. 52nd Annual Meeting of the European

Association for the Study of Diabetes (EASD), Munich, Germany; 12-16 September

2016.

3. Kapitza C, Dahl K, Jaconsen B, et al. The effects of once-weekly semaglutide

on ß-cell function in subjects with type 2 diabetes. Abstract 754. 52nd Annual

Meeting of the European Association for the Study of Diabetes (EASD), Munich,

Germany; 12-16 September 2016.

4. Blundell J, Finlayson G, Axelsen MB, et al. Effects of once-weekly

semaglutide on appetite, energy intake, control of eating, food preference and

body weight in subjects with obesity. Diabetes Obes Metab. 2017; ePub ahead of

print. DOI: 10.1111/dom.12932.

5. Saad H, Hjersted J, Axelsen MB, et al. Semaglutide improves postprandial

glucose and lipid metabolism and delays first-hour gastric emptying in subjects

with obesity. Canadian Journal of Diabetes. 2016; 40:S34-S35.

Further information

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SOURCE: Novo Nordisk