BAGSVÆRD, Denmark, February 1, 2018 /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. 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.
"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. 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).
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.
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.
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. 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.
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.
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. 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.
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