ORLANDO, Fla., May 27, 2016 /PRNewswire/ -- 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 glycemic 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,
Fla.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. "The results of
SUSTAIN 4 are encouraging, as once-weekly semaglutide demonstrated
superior glycemic 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/205.91 lb, 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%; diarrhea: 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 hypoglycemia 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 SUSTAIN 4
SUSTAIN 4 was a randomized, open-label, multicenter,
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 program
SUSTAIN (Semaglutide Unabated Sustainability in Treatment of
Type 2 Diabetes) is a clinical program 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 health care 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 with other serious chronic conditions:
hemophilia, growth disorders and obesity. With U.S. headquarters in
Plainsboro, N.J., Novo Nordisk
Inc. has more than 5,000 employees in the
United States. For more information, visit novonordisk.us or
follow us on Twitter: @novonordiskus.
References
- Aroda VR, Bain SC, Cariou B, et al. Efficacy and safety of
once-weekly seamglutide 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.
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