ORLANDO, Florida, May 27, 2016 /PRNewswire/ --
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Abstract #290
Findings from a phase 3a clinical trial for semaglutide, an
investigational glucagon-like peptide-1 (GLP-1) analogue,
demonstrated that treatment with semaglutide, administered
once-weekly, significantly improved glycaemic control compared to
insulin glargine U100 in adults with type 2 diabetes. Results from
the SUSTAIN 4 trial were presented today at the American
Association of Clinical Endocrinologists 25th Annual
Scientific and Clinical Congress (AACE) in Orlando,
US.[1]
The 30-week SUSTAIN 4 trial showed that, from a mean baseline
HbA1c of 8.2%, adults with type 2 diabetes receiving
metformin with or without sulfonylurea, achieved statistically
significant and superior improvements in HbA1c
reductions of 1.2% and 1.6% when treated with 0.5 mg and 1.0 mg
semaglutide, respectively, vs a 0.8% reduction with insulin
glargine U100 (p<0.0001 for
both).[1] End of trial mean dose
of insulin glargine U100 was 29 IU/day.
"Type 2 diabetes is a complex disease and many patients on
insulin are still uncontrolled," said Vanita Aroda, SUSTAIN 4 investigator and
Physician Investigator at the MedStar Health Research Institute,
Hyattsville, MD, US. "The results
of SUSTAIN 4 are encouraging, as once-weekly semaglutide
demonstrated superior glycaemic control compared to insulin
glargine U100 in people that generally had a relatively long
duration of type 2 diabetes."
More adults treated with 0.5 mg and 1.0 mg semaglutide achieved
HbA1c targets compared with insulin glargine U100:
HbA1c <7% (57.5% and 73.3% vs 38.1%) and ≤6.5% (37.3%
and 54.2% vs 17.5%).[1]
Additionally, from a mean baseline body weight of 93.4 kg, adults
treated with 0.5 mg and 1.0 mg semaglutide achieved statistically
significant and superior reductions in mean body weight of 3.5
kg/7.72 lb and 5.2 kg/11.46 lb compared to an increase of 1.2
kg/2.65 lb with insulin glargine U100 (p<0.0001 for
both).[1]
The most common adverse events observed for adults treated with
0.5 mg and 1.0 mg semaglutide were gastrointestinal (nausea: 21.3%
and 22.2% vs insulin glargine U100, 3.6%; diarrhoea: 16.3% and
19.2% vs insulin glargine U100, 4.4%; vomiting: 6.6% and 10.3% vs
insulin glargine U100, 3.1%). Rates of serious adverse events were
comparable across treatment groups (6.1% and 4.7% vs 5.0%). Fewer
adults reported severe or blood glucose-confirmed hypoglycaemia
with either semaglutide dose compared to insulin glargine U100
(4.4% and 5.6% vs 10.6%). The proportion of adults treated with 0.5
mg and 1.0 mg semaglutide discontinuing treatment due to adverse
events was 5.5% and 7.5% vs 1.1% for insulin glargine
U100.[1]
About semaglutide
Semaglutide is an investigational analogue of native human
glucagon-like peptide-1 (GLP-1) that stimulates insulin and
suppresses glucagon secretion in a glucose-dependent manner, as
well as decreases appetite and food
intake.[2] Semaglutide
administered subcutaneously once-weekly is in phase 3 development
for the treatment of adults with type 2 diabetes.
About SUSTAIN 4
SUSTAIN 4 was a randomised, open-label, multicentre,
multinational 30-week trial investigating the safety and efficacy
of semaglutide, administered once-weekly, vs once-daily insulin
glargine (U100/mL), both added on to metformin with or without
sulfonylurea in 1,089 adults with an overall type 2 diabetes
duration of 8.6 years and who had not previously received any
insulin-based therapies. Secondary endpoints included change in
body weight from baseline after 30 weeks of treatment. The trial
was conducted in Argentina,
Croatia, France, Germany, India, Macedonia, Mexico, the
Netherlands, Puerto Rico,
Romania, Slovakia, Slovenia, South
Africa, UK and the US.
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 people with type 2
diabetes as well as two Japanese trials encompassing around 1,000
people 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
41,600 people in 75 countries and markets its products in more than
180 countries. For more information, visit
http://www.novonordisk.com, Facebook,
Twitter, LinkedIn, YouTube
Further information
Media:
Katrine Sperling
+45-4442-6718
krsp@novonordisk.com
Åsa 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
Kasper Veje (US)
+1-609-235-8567
kpvj@novonordisk.com
References
1. Aroda VR, Bain SC, Cariou B, et al.
Efficacy and safety of once-weekly semaglutide vs once-daily
insulin glargine in insulin-naïve subjects with type 2 diabetes
(SUSTAIN 4). Abstract number 290. American Association of
Clinical Endocrinologists 25th Annual
Scientific and Clinical Congress (AACE), Orlando, FL, US; 25-29
May 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.