Once-weekly Semaglutide Demonstrated Consistent Blood Glucose Reductions and Weight Loss Regardless of Background Oral Antidiabetic Treatment

PR68047

ORLANDO, Florida Apr. 3, 2017, PRNewswire=KYODO JBN /--

     Abstract #620

    Findings from a post hoc analysis of the phase 3a SUSTAIN 2-4 trials

demonstrated greater mean reductions in HbA1c and body weight with once-weekly

semaglutide treatment compared to sitagliptin, exenatide extended release (ER)

and insulin glargine U100 in adults with type 2 diabetes, across multiple

background oral antidiabetic (OAD) treatment categories. The results were

presented today at the Endocrine Society's 99th Annual Meeting and Expo (ENDO

2017) in Orlando, FL, US.[1]

    "Type 2 diabetes is a complex disease, and as a result many patients are

not reaching their targets on current oral antidiabetic therapy," said Vanita

Aroda, SUSTAIN 4 investigator and physician investigator at the MedStar Health

Research Institute, Hyattsville, MD, US. "Results from this post hoc analysis

show that once-weekly semaglutide consistently lowered blood glucose and weight

in people with type 2 diabetes regardless of their current oral antidiabetic

therapy."

    On a background of metformin or metformin plus sulfonylurea, treatment with

semaglutide (0.5 mg/1.0 mg) significantly reduced HbA1c compared with all

treatment comparators (p＜0.05). In the smaller groups of people on a background

of less commonly used OADs (thiazolidinedione [TZD] alone, or TZD in

combination with metformin or sulfonylurea), semaglutide 1.0 mg significantly

reduced HbA1c vs. sitagliptin (p＜0.05); there was a numerically greater

reduction in HbA1c with semaglutide 0.5 mg vs. sitagliptin (p=non-significant

[ns]); and semaglutide 1.0 mg demonstrated a greater reduction in HbA1c vs.

exenatide ER, although statistical significance was not reached.[1]

    Furthermore, people treated with semaglutide 1.0 mg achieved significantly

greater reductions in mean body weight across all OAD categories vs. all

comparators (p＜0.05). People treated with semaglutide 0.5 mg on a background of

metformin or metformin plus sulfonylurea achieved significantly greater

reductions in mean body weight vs. sitagliptin,  exenatide ER and insulin

glargine U100 (p＜0.0001). The reductions seen across the background treatment

category of OADs less commonly used in this post hoc analysis did not reach

statistical significance.[1]

    The rate of severe or blood glucose-confirmed symptomatic hypoglycaemia for

people treated with semaglutide (0.5 mg/1.0 mg) was comparable with sitagliptin

and exenatide ER and lower compared with insulin glargine U100, irrespective of

background OAD treatment.[1]

    Semaglutide was well tolerated, with a similar safety profile to that of

other GLP-1 receptor agonists.[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 the US Food and Drug

Administration, the European Medicines Agency and the Japanese Pharmaceuticals

and Medical Devices Agency. If approved, the indication of once-weekly

semaglutide will reflect the trial results and assessment by the regulatory

authorities.

    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 42,000 people in

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

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

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     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;

     Hanna Ogren

     +45-3079-8519

     haoe@novonordisk.com;

     Anders Mikkelsen

     +45-3079-4461

     armk@novonordisk.com;

     Kasper Veje (US)

     +1-609-235-8567;

     kpvj@novonordisk.com

References

    1. Aroda V, Pablo Frias J, Tabak O, et al. Semaglutide reduces HbA1c and

body weight across multiple background OAD treatment categories. Abstract 620.  

99th Annual Meeting of the Endocrine Society (ENDO), Orlando, USA; 1-4 April

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. European Association for the Study of

Diabetes, 52nd Annual Meeting (EASD), Munich, Germany; 12-16 September 2016.

    3. Blundell J, Finlayson G, Bhuhl Axelsen M, et al. Semaglutide reduces

appetite and energy intake, improves control of eating and provides weight loss

in subjects with obesity. American Diabetes Association, 76th Annual Meeting

(ADA), New Orleans, USA; 10-14 June 2016.

    4. Hjerpsted J, Buhl Axelsen M, Brooks A, et al. Semaglutide Improves

Postprandial Glucose and Lipid Metabolism and Delays First-Hour Gastric

Emptying in Subjects with Obesity. Abstract 1046. American Diabetes

Association, 76th Annual Meeting (ADA), New Orleans, USA; 10-14 June 2016.

    5. 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.

European Association for the Study of Diabetes, 52nd Annual Meeting (EASD),

Munich, Germany; 12-16 September 2016.

SOURCE: Novo Nordisk