Semaglutide superior to dulaglutide on glucose control and weight loss in people with type 2 diabetes in SUSTAIN 7
(Thomson Reuters ONE) -
Bagsværd, Denmark, 16 August 2017 - Novo Nordisk today announced the SUSTAIN 7
trial results, demonstrating that people with type 2 diabetes treated with once-
weekly semaglutide experienced superior reduction in HbA(1c) and body weight
compared to treatment with dulaglutide. The 40-week trial investigated the
efficacy and safety of 0.5 mg semaglutide compared with 0.75 dulaglutide and
1.0 mg semaglutide compared with 1.5 mg dulaglutide, when added to metformin.
From a mean baseline HbA(1c) of 8.2%, 0.5 mg semaglutide achieved a
statistically significant and superior reduction of 1.5% compared with a
reduction of 1.1% with 0.75 mg dulaglutide. People treated with 1.0 mg
semaglutide experienced a statistically significant and superior reduction of
1.8% compared with a reduction of 1.4% with 1.5 mg dulaglutide.
Using the American Diabetes Association (ADA) treatment target of HbA(1c) below
or equal to 7.0%, 69% of people treated with 0.5 mg semaglutide compared with
52% of people treated with 0.75 mg dulaglutide reached the treatment goal, and
79% of people treated with 1.0 mg semaglutide compared to 68% with 1.5 mg
dulaglutide reached the treatment goal.
Using the American Association of Clinical Endocrinologists (AACE) treatment
target of HbA(1c) below or equal to 6.5%, 51% of people treated with 0.5 mg
semaglutide compared with 36% of people treated with 0.75 mg dulaglutide reached
the treatment goal, and 68% of people treated with 1.0 mg semaglutide compared
to 49% with 1.5 mg dulaglutide reached the treatment goal.
Furthermore, from a mean baseline body weight of 95 kg and a BMI of 33.5
kg/m(2), people treated with 0.5 mg semaglutide experienced a statistically
significant and superior weight loss of 4.6 kg compared to 2.3 kg with 0.75 mg
dulaglutide. People treated with 1.0 mg semaglutide experienced a statistically
significant and superior weight loss of 6.5 kg compared to 3.0 kg with 1.5 mg
dulaglutide.
44% of people treated with 0.5 mg semaglutide compared with 23% of people
treated with 0.75 mg dulaglutide achieved more or equal to 5% body weight loss
and 63% of people with 1.0 mg semaglutide compared with 30% of people treated
with 1.5 mg dulaglutide.
In the trial, semaglutide demonstrated a safe and well-tolerated profile
consistent with results from the SUSTAIN programme. The most common adverse
event for both semaglutide dosages was mild to moderate nausea, which was
overall comparable to dulaglutide and diminished over time. Premature treatment
discontinuation due to adverse events was less than 10% across all treatment
groups. The number of people reporting an adverse event of diabetic retinopathy
was low and comparable in both the semaglutide and dulaglutide groups (4 and 5
events, respectively).
"The superior glucose control and weight loss achieved with semaglutide compared
to dulaglutide in this trial reinforces the unprecedented results observed in
the entire SUSTAIN programme" said Mads Krogsgaard Thomsen, executive vice
president and chief science officer of Novo Nordisk. "We are excited about the
potential of semaglutide to set a new standard for treatment of type 2
diabetes".
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. Once-weekly semaglutide is
currently under review by seven regulatory agencies, including the US Food and
Drug Administration, the European Medicines Agency and the Japanese
Pharmaceuticals and Medical Devices Agency.
SUSTAIN 7
SUSTAIN 7 is a phase 3b, 40-week, efficacy and safety trial of 0.5 mg
semaglutide vs 0.75 mg dulaglutide and 1.0 mg semaglutide vs 1.5 mg dulaglutide,
both once-weekly, as add-on to metformin in 1,201 people with type 2 diabetes.
The primary outcome measure was change in HbA(1c) from baseline after 40 weeks
of treatment with semaglutide compared to dulaglutide.
About the SUSTAIN clinical 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 3 global clinical trials, including a cardiovascular
outcomes trial, involving more than 8,000 adults with type 2 diabetes.
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
Hanna Ögren +45 3079 8519 haoe(at)novonordisk.com
Anders Mikkelsen +45 3079 4461 armk(at)novonordisk.com
Christina Jensen +45 3079 3009 cnje(at)novonordisk.com
Kasper Veje (US) +1 609 235 8567 kpvj(at)novonordisk.com
Company announcement No 65 / 2017
PR170816_SUSTAIN_7_UK:
http://hugin.info/2013/R/2127298/812538.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novo Nordisk A/S via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 16.08.2017 - 20:02 Uhr
Sprache: Deutsch
News-ID 556836
Anzahl Zeichen: 5965
contact information:
Town:
Bagsvaerd
Kategorie:
Business News
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