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