Semaglutide Demonstrated Superior HbA1c Reduction vs Placebo as Add-on to Basal Insulin Alone or with Metformin in Adults with type 2 Diabetes

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MUNICH, Sept.13 /PRNewswire=KYODO JBN/ --

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    Novo Nordisk today announced that semaglutide, an investigational

glucagon-like peptide-1 (GLP-1) analogue administered once-weekly,

significantly improved glycaemic control compared to placebo, as add-on to

basal insulin alone or in combination with metformin, in adults with a mean

type 2 diabetes duration of 13 years. Results from SUSTAIN 5 were presented

today at the 52nd Annual Meeting of the European Association for the Study of

Diabetes (EASD) 2016.[1]

    The 30-week trial showed that, from a mean baseline HbA1c of 8.4%, adults

treated with 0.5 mg and 1.0 mg semaglutide achieved statistically significant

and superior HbA1c reductions of 1.4% and 1.8%, respectively, vs 0.1% reduction

with placebo. In addition, more adults treated with 0.5 mg and 1.0 mg

semaglutide achieved HbA1c targets compared with placebo: HbA1c ＜7% (61% and

79% vs 11%) and less than or equal to6.5% (41% and 61% vs 5%).[1]

    Adults with type 2 diabetes treated with 0.5 mg and 1.0 mg semaglutide

achieved superior weight loss vs placebo (3.7 kg and 6.4 kg vs 1.4 kg) from a

mean baseline body weight of 91.7 kg.[1]

    "In the SUSTAIN 5 trial, we have seen that adding once-weekly semaglutide

to basal insulin alone or in combination with metformin can help people with

long-standing type 2 diabetes achieve glycaemic control and weight loss," said

Dr Helena Rodbard, SUSTAIN 5 investigator and Medical Director at Endocrine and

Metabolic Consultants, Rockville, Maryland. "As a treating physician, I am

encouraged by these findings as many people with long-standing type 2 diabetes

experience suboptimal glucose control and weight gain."

    Adults treated with both doses of semaglutide demonstrated significantly

greater reductions in fasting plasma glucose (FPG) vs placebo (1.6 mmol/L and

2.4 mmol/L vs 0.5 mmol/L), from a mean FPG baseline of 8.6 mmol/L. Furthermore,

both semaglutide doses resulted in significant postprandial glucose reduction,

measured as the postprandial increment of 7-point self-measured plasma glucose

compared to placebo.[1]

    Adverse events were reported for 68.9% and 64.1% of adults treated with 0.5

mg and 1.0 mg semaglutide, respectively, and for 57.9% of adults treated with

placebo. The rates of serious adverse events observed for adults treated with

0.5 mg and 1.0 mg semaglutide compared with placebo were 6.1% and 9.2% vs 6.8%.

The proportion of adults treated with 0.5 mg and 1.0 mg semaglutide

discontinuing due to adverse events were 4.5% and 6.1% vs 0.8% with placebo;

the majority of discontinuations with semaglutide were due to gastrointestinal

adverse events.[1]

    About semaglutide

    Semaglutide is a once-weekly investigational 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] With SUSTAIN 6, semaglutide administered subcutaneously once-weekly

has completed six phase 3a clinical trials for the treatment of adults with

type 2 diabetes.

    About SUSTAIN 5

    SUSTAIN 5 is a randomised, double-blind, placebo-controlled, parallel-group

and multi-national trial investigating the safety and efficacy of semaglutide,

administered once-weekly, vs placebo both as add-on to basal insulin alone or

basal insulin in combination with metformin in 397 adults with a mean type 2

diabetes duration of 13.3 years. The primary end point was change in HbA1c from

baseline after 30 weeks of treatment. Secondary endpoints included change in

body weight from baseline after 30 weeks of treatment. The trial was conducted

in the US, Germany, Japan, Puerto Rico, Serbia and Slovakia.

    About the SUSTAIN clinical programme

    SUSTAIN (Semaglutide Unabated Sustainability in Treatment of Type 2

Diabetes) is a clinical programme for semaglutide, administered once-weekly,

that comprises six phase 3a global clinical trials encompassing more than 7,000

adults with type 2 diabetes as well as two Japanese trials encompassing around

1,000 adults with type 2 diabetes.

    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 42,300 people in

75 countries and markets its products in more than 180 countries. For more

information, visit novonordisk.com [http://www.novonordisk.com ], Facebook

[http://www.facebook.com/novonordisk ], Twitter

[http://www.twitter.com/novonordisk ],  LinkedIn

[http://www.linkedin.com/company/novo-nordisk ], YouTube

[http://www.Youtube.com/novonordisk ]

    Further Information

    Media:  

    Katrine Sperling

    +45-4442-6718

    krsp@novonordisk.com  

    Asa Josefsson

    +45-3079-7708

    aajf@novonordisk.com  

    Investors:

    Peter Hugreffe Ankersen

    +45-3075-9085

    phak@novonordisk.com  

    Melanie Raouzeos

    +45-3075-3479

    mrz@novonordisk.com  

    Hannah Ogren

    +45-3075-8519

    haoe@novonordisk.com  

    Kasper Veje (US)

    +1-609-235-8567

    kpvj@novonordisk.com  

    References

    1. Rodbard, H, Lingvay, I, Reed, J et al. Efficacy and safety of

semaglutide onceweekly vs placebo as addon to basal insulin alone or in

combination with metformin in subjects with type 2 diabetes (SUSTAIN 5). Poster

number 766. European Association for the Study of Diabetes, Munich, Germany;

12-16 September 2016.

    2. Nauck MA, Petrie JR, Sesti G, et al. A phase 2, randomized, dose-finding

study of the novel once-weekly human GLP-1 analog, semaglutide, compared with

placebo and open-label liraglutide in patients with type 2 diabetes. Diabetes

Care. 2015; 39:231-241.

SOURCE: Novo Nordisk