Novo Nordisk successfully completes fifth phase 3a trial with semaglutide in people with type 2 diabetes
(Thomson Reuters ONE) -
Bagsværd, Denmark, 23 February 2016 - Novo Nordisk today announced the headline
results from the fifth phase 3a trial for semaglutide, SUSTAIN5. Semaglutide is
a new GLP-1 analogue, which in the SUSTAIN trials is administered subcutaneously
once weekly. The double-blinded trial investigated the efficacy and safety of
0.5 mg and 1.0 mg semaglutide compared with placebo as add-on to basal insulin
alone or basal insulin in combination with metformin, after 30 weeks of
treatment in 397 people with type 2 diabetes.
The trial successfully achieved its objective by demonstrating that people
treated with 0.5 mg or 1.0 mg semaglutide achieved a statistically significant
and superior improvement in HbA(1c) of 1.4% and 1.8% respectively, from a mean
baseline HbA(1c) of 8.4%, compared with an improvement in HbA(1c) of 0.1% with
placebo. Additionally, the end of trial insulin dose for people treated with
0.5 mg and 1.0 mg semaglutide was reduced by 10% and 15% respectively, compared
with 3% for the placebo group.
61% of the people treated with 0.5 mg semaglutide and 79% of the people treated
with 1.0 mg semaglutide achieved the treatment target of HbA(1c) below 7% set by
the American Diabetes Association (ADA) and the European Association for the
Study of Diabetes (EASD), compared with 11% of the people treated with placebo.
From a mean baseline body weight of 92 kg, people treated with 0.5 mg and 1.0 mg
semaglutide experienced a statistically significant and superior weight loss of
3.7 kg and 6.4 kg respectively, compared with a weight loss of 1.4 kg for people
treated with placebo.
In the trial, semaglutide appeared to have a safe and well-tolerated profile.
The most common adverse event was nausea. Nausea was reported by 11% of the
people treated with 0.5 mg semaglutide and by 17% of the people treated with
1.0 mg semaglutide, compared with 5% of people treated with placebo. Severe or
blood glucose-confirmed symptomatic hypoglycaemia was experienced by 8% and 11%
of people treated with 0.5 mg or 1.0 mg once-weekly semaglutide respectively,
compared with 5% in the placebo group. The discontinuation rate due to adverse
events was 5% and 6% for people treated with 0.5 mg semaglutide and 1.0 mg
semaglutide respectively, compared to 1% for people treated with placebo.
"We are excited about the results of SUSTAIN 5, showing superior efficacy in
glycaemic control and weight loss with semaglutide administered once-weekly in
patients inadequately controlled on basal insulin" says Mads Krogsgaard Thomsen,
executive vice president and chief science officer of Novo Nordisk. "The results
from the first five SUSTAIN trials support the potential for broad usage of
semaglutide in people with type 2 diabetes, as results have been consistent when
exploring people with both early onset as well as late stage type 2 diabetes."
Novo Nordisk expects to announce headline results of the final SUSTAIN trial,
SUSTAIN 6 in the first half of 2016.
About semaglutide
Semaglutide is a new glucagon-like peptide-1 (GLP-1) analogue that can help
people with type 2 diabetes achieve substantial improvement of blood glucose
with a low risk of hypoglycaemia. In addition, semaglutide induces weight loss
by decreasing appetite and food intake. Semaglutide administered subcutaneously
once weekly is in phase 3 development for the treatment of type 2 diabetes.
Furthermore, semaglutide is being developed in an oral tablet version for
treatment of type 2 diabetes as well as once-daily subcutaneous versions for
treatment of type 2 diabetes and weight management.
About the SUSTAIN clinical programme
The SUSTAIN programme is a phase 3 clinical programme comprising six global
trials of semaglutide administered subcutaneously once weekly encompassing more
than 7,000 people with type 2 diabetes.
SUSTAIN 1 - a 30-week efficacy and safety trial of semaglutide versus placebo in
388 drug-naïve people with type 2 diabetes.
SUSTAIN 2 - a 56-week efficacy and safety trial of semaglutide versus
sitagliptin once-daily as add-on to metformin and/or TZD in 1,231 people with
type 2 diabetes.
SUSTAIN 3 - a 56-week efficacy and safety trial of semaglutide versus 2.0 mg
exenatide once-weekly as add-on to 1-2 oral antidiabetic drugs in 813 people
with type 2 diabetes.
SUSTAIN 4 - a 30-week efficacy and safety trial of semaglutide versus insulin
glargine once-daily as add-on to metformin with or without sulfonylurea in
1,089 insulin-naïve people with type 2 diabetes.
SUSTAIN 5 - a 30-week efficacy and safety trial of semaglutide versus placebo as
add-on to basal insulin alone or basal insulin in combination with metformin in
397 people with type 2 diabetes.
SUSTAIN 6 - a 2-year trial not yet reported to evaluate cardiovascular and other
long-term outcomes with semaglutide in 3,297 people with type 2 diabetes.
For further information
Media:
Katrine Sperling +45 3079 6718 krsp(at)novonordisk.com
Ken Inchausti (US) +1 609 786 8316 kiau(at)novonordisk.com
Investors:
Peter Hugreffe Ankersen +45 3075 9085 phak(at)novonordisk.com
Daniel Bohsen +45 3079 6376 dabo(at)novonordisk.com
Melanie Raouzeos +45 3075 3479 mrz(at)novonordisk.com
Kasper Veje +45 3079 8519 kpvj(at)novonordisk.com
Company announcement No 18 / 2016
Company announcement No 18 / 2016:
http://hugin.info/2013/R/1988465/730077.pdf
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Novo Nordisk A/S via GlobeNewswire
[HUG#1988465]
Unternehmensinformation / Kurzprofil:
Datum: 23.02.2016 - 11:53 Uhr
Sprache: Deutsch
News-ID 452664
Anzahl Zeichen: 6633
contact information:
Town:
Bagsvaerd
Kategorie:
Business News
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