Semaglutide Demonstrated Significant Reductions in Blood Sugar and Weight Compared with Dulaglutide
Semaglutide Demonstrated Significant Reductions in Blood Sugar and Weight Compared with Dulaglutide; Results Published in The Lancet Diabetes & Endocrinology
PR72122
BAGSVAERD, Denmark, February 1, 2018 /PRNewswire=KYODO JBN/ --
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, Facebook, Twitter, LinkedIn, YouTube.
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/article/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. Ahren 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
Asa Josefsson, +45-3079-7708, aajf@novonordisk.com
Investors:
Peter Hugreffe Ankersen, +45-3075-9085, phak@novonordisk.com
Hanna Ogren, +45-3079-8519, haoe@novonordisk.com
Anders Mikkelsen, +45-3079-4461, armk@novonordisk.com
Christina Kjaer, +45-3079-3009, cnje@novonordisk.com
Source: Novo Nordisk
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