Semaglutide Demonstrated Significant Reductions in Blood Sugar and Weight Compared with Dulaglutide; Results Published in The Lancet Diabetes & Endocrinology

Bagsværd, Denmark (ots/PRNewswire) -

Results from the SUSTAIN 7 trial, which investigated the efficacy
and safety of 0.5 mg semaglutide compared with 0.75 mg dulaglutide
and 1.0 mg semaglutide compared with 1.5 mg dulaglutide, when added
to metformin, have been published in The Lancet Diabetes &
Endocrinology.[1] The 40-week trial showed that people with type 2
diabetes treated with once-weekly semaglutide experienced
statistically greater reductions in HbA1c and body weight compared to
treatment with dulaglutide.[1]

"It is imperative that clinical trial findings are published and
made available to clinicians and the scientific community," said Mads
Krogsgaard Thomsen, executive vice president and chief science
officer at Novo Nordisk. "SUSTAIN 7 is an important head-to-head
trial, demonstrating significant efficacy of once-weekly semaglutide
vs dulaglutide, and we are pleased that the full manuscript is now
available in The Lancet Diabetes & Endocrinology."

From a mean baseline of 8.2%, HbA1c was reduced by 1.5% with
semaglutide 0.5 mg compared to 1.1% with dulaglutide 0.75 mg. At the
high doses, semaglutide 1.0 mg reduced HbA1c by 1.8% compared to 1.4%
with dulaglutide 1.5 mg. The estimated treatment difference (ETD) was
statistically significant in both the low-dose and high-dose
comparisons at -0.40% and -0.41%, respectively.[1] The HbA1c and body
weight reductions achieved with semaglutide in SUSTAIN 7 were
consistent with those results observed in the other efficacy studies
in the SUSTAIN clinical trial programme.[2-6]

"As a clinician, I know first-hand how challenging it can be to
help people living with type 2 diabetes reach their treatment goals,"
said Richard E. Pratley, lead author and diabetes program lead at the
Translational Research Institute for Metabolism and Diabetes,
Florida, US. "Type 2 diabetes is a complex disease and the
significant glucose control and weight loss achieved with once-weekly
semaglutide compared with dulaglutide are encouraging, as more
treatment options are needed."

Using the American Diabetes Association (ADA) treatment target of
HbA1c below 7.0%, significantly more people treated with semaglutide
compared with dulaglutide, at both dose levels, achieved the ADA
treatment target (68% and 79% on 0.5 mg and 1.0 mg semaglutide vs 52%
and 67% on 0.75 mg and 1.5 mg dulaglutide).[1]

Furthermore, from a mean baseline of 95.2 kg, body weight was
reduced by 4.6 kg in people treated with semaglutide 0.5 mg compared
with 2.3 kg in people treated with dulaglutide 0.75 mg, and by 6.5 kg
in people treated with semaglutide 1.0 mg compared with 3.0 kg in
people treated with dulaglutide 1.5 mg.[1]

The overall safety profiles of semaglutide and dulaglutide were
similar in SUSTAIN 7. Gastrointestinal disorders were the most
frequently reported adverse events and occurred in a similar
proportion of people receiving semaglutide 0.5 mg (129 patients;
43%), semaglutide 1.0 mg (133 patients; 44%) and dulaglutide 1.5 mg
(143 patients; 48%); fewer people experienced gastrointestinal
disorders with dulaglutide 0.75 mg (100 patients; 33%). Premature
treatment discontinuation due to adverse events was less than 10%
across all treatment groups.[1]

About the SUSTAIN 7 trial

SUSTAIN 7 is a phase 3b, 40-week, efficacy and safety trial of 0.5
mg semaglutide (n=301) vs 0.75 mg dulaglutide (n=299) and 1.0 mg
semaglutide (n=300) vs 1.5 mg dulaglutide (n=299), both once-weekly,
as add-on to metformin in 1,201 people with type 2 diabetes. The
primary outcome measure was change in HbA1c from baseline after 40
weeks of treatment with semaglutide compared to dulaglutide.[1]
Change in body weight from baseline to week 40, and the HbA1c
treatment target of below 7.0% at 40 weeks, were predefined secondary
endpoints.[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.

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 95
years of innovation and leadership in diabetes care. This heritage
has given us experience and capabilities that also enable us to help
people defeat obesity, haemophilia, growth disorders and other
serious chronic diseases. Headquartered in Denmark, Novo Nordisk
employs approximately 42,100 people in 79 countries and markets its
products in more than 170 countries. For more information, visit
novonordisk.com (https://www.novonordisk.com/), Facebook
(http://www.facebook.com/novonordisk), Twitter
(http://www.twitter.com/novonordisk), LinkedIn
(http://www.linkedin.com/company/novo-nordisk), YouTube
(http://www.Youtube.com/novonordisk).

References

1. Pratley RE, Aroda VR, Lingvay I, et al. Semaglutide versus
dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7):
a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol
. 2018; In Press. DOI: http://www.thelancet.com/journals/landia/artic
le/PIIS2213-8587(18)30024-X/fulltext?elsca1=tlxpr.

2. Sorli C, Harashima SI, Tsoukas GM, et al. Efficacy and safety
of once-weekly semaglutide monotherapy versus placebo in patients
with type 2 diabetes (SUSTAIN 1): a double-blind, randomised,
placebo-controlled, parallel-group, multinational, multicentre phase
3a trial. Lancet Diabetes Endocrinol. 2017;5: 251-260.

3. Ahrén B, Masmiquel L, Kumar H, et al. Efficacy and safety of
once-weekly semaglutide versus once-daily sitagliptin as an add-on to
metformin, thiazolidinediones, or both, in patients with type 2
diabetes (SUSTAIN 2): A 56-week, double-blind, phase 3a, randomised
trial. Lancet Diabetes Endocrinol. 2017;5: 341-354.

4. Ahmann AJ, Capehorn M, Charpentier G, et al. Efficacy and
Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects
With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized
Clinical Trial. Diabetes Care. 2018;41: 258-266.

5. Aroda VR, Bain SC, Cariou B, et al. Efficacy and safety of
once-weekly semaglutide versus once-daily insulin glargine as add-on
to metformin (with or without sulfonylureas) in insulin-naive
patients with type 2 diabetes (SUSTAIN 4): A randomised, open-label,
parallel-group, multicentre, multinational, phase 3a trial. Lancet
Diabetes Endocrinol. 2017;5: 355-366.

6. Rodbard H, Lingvay I, Reed J, et al. Efficacy and safety of
semaglutide once-weekly vs placebo as add-on to basal insulin alone
or in combination with metformin in subjects with type 2 diabetes
(SUSTAIN 5). Abstract 766. 52nd Annual Meeting of the European
Association for the Study of Diabetes (EASD), Munich, Germany; 12-16
September 2016.

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

Hanna Ögren, +45-3079-8519, haoe@novonordisk.com

Anders Mikkelsen, +45-3079-4461, armk@novonordisk.com

Christina Kjær, +45-3079-3009, cnje@novonordisk.com

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