CC BY-NC-ND 4.0 · Exp Clin Endocrinol Diabetes 2023; 131(04): 205-215
DOI: 10.1055/a-2007-2061
Article

Real-World Use of Once-Weekly Semaglutide in Type 2 Diabetes: Results from SemaglUtide Real-world Evidence (SURE) Germany

1   Gemeinschaftskrankenhaus Bonn, Innere Medizin – Diabetologie und Endokrinologie, Bonn, Germany
,
Tina Landsvig Berentzen
2   Novo Nordisk A/S, Søborg, Denmark
,
Andrei-Mircea Catarig
2   Novo Nordisk A/S, Søborg, Denmark
,
Sebastian Pieperhoff
3   Novo Nordisk Pharma GmbH, Mainz, Germany
,
Jörg Simon
4   MVZ im Altstadt-Carree Fulda GmbH, Fulda, Germany
,
Stephan Jacob
5   Cardio-metabolic Institute, Villingen, Germany
› Author Affiliations
Funding This study was funded by Novo Nordisk A/S.

Abstract

Context Efficacy and safety of once-weekly semaglutide in type 2 diabetes were established in the phase 3 SUSTAIN trials, which included patients across the continuum of type 2 diabetes care. It is useful to complement these findings with real-world evidence.

Objective SURE Germany evaluated once-weekly semaglutide in a real-world type 2 diabetes patient population.

Design/setting The prospective observational study was conducted at 93 clinical practices in adults with+≥ 1 documented glycated haemoglobin value ≤12 weeks before initiation of semaglutide.

Intervention Once-weekly semaglutide was prescribed at the physicians’ discretion.

Main outcomes The primary endpoint was change in glycated haemoglobin from baseline to end-of-study (~30 weeks). Secondary endpoints included changes in body weight and patient-reported outcomes. All adverse events were systematically collected and reported, including patient-reported documented and/or severe hypoglycaemia.

Results Of 779 patients in the full analysis set, 669 (85.9%) completed the study on treatment with semaglutide, comprising the effectiveness analysis set. In this data set, estimated mean changes in glycated haemoglobin and body weight from baseline to end-of-study were –1.0%point (–10.9 mmol/mol; P<0.0001) and –4.5 kg (–4.2%; P<0.0001). Sensitivity analyses supported the primary analysis. Improvements were observed in other secondary endpoints, including patient-reported outcomes. No new safety concerns were identified.

Conclusions In a real-world population in Germany, patients with type 2 diabetes treated with once-weekly semaglutide experienced clinically significant improvements in glycaemic control and body weight. These results support the use of once-weekly semaglutide in routine clinical practice in adult patients with type 2 diabetes in Germany.

Supplementary Material



Publication History

Received: 28 September 2022
Received: 14 November 2022

Accepted: 13 December 2022

Accepted Manuscript online:
04 January 2023

Article published online:
03 March 2023

© 2023. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 
  • References

  • 1 Deutsche Diabetes Gesellschaft. Gesundheitsbericht Diabetes 2021. https://www.diabetesde.org/system/files/documents/20201107_gesundheitsbericht2021.pdf. Accessed July 2022
  • 2 Davies MJ, D'Alessio DA, Fradkin J. et al. Management of hyperglycemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2018; 41: 2669-2701
  • 3 American Diabetes Association. 6. Glycemic targets: Standards of medical care in diabetes-2022. Diabetes Care 2022; 45: S83-S96
  • 4 Chung WK, Erion K, Florez JC. et al. Precision medicine in diabetes: A consensus report from the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2020; 43: 1617-1635
  • 5 Davies MJ, Aroda VR, Collins BS. et al. Management of hyperglycaemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia 2022; 24: 1-42
  • 6 National Care Guideline (NVL) Type 2 Diabetes – Partial Publication, 2nd edition. Nationale Versorgungs Leitlinien. https://www.leitlinien.de/themen/diabetes. Accessed October 2022
  • 7 Gilbert MP, Pratley RE.. GLP-1 analogs and DPP-4 inhibitors in type 2 diabetes therapy: Review of head-to-head clinical trials. Front Endocrinol (Lausanne) 2020; 11: 178
  • 8 Prasad-Reddy L, Isaacs D.. A clinical review of GLP-1 receptor agonists: Efficacy and safety in diabetes and beyond. Drugs Context 2015; 4: 212283
  • 9 Lau J, Bloch P, Schäffer L. et al. Discovery of the once-weekly glucagon-like peptide-1 (GLP-1) analogue semaglutide. J Med Chem 2015; 58: 7370-7380
  • 10 Novo Nordisk. Ozempic (semaglutide) 0.25 mg, 0.5 mg, 1 mg, 2 mg solution for injection in pre-filled pen. Summary of Product Characteristics. 2022. https://www.ema.europa.eu/en/documents/product-information/ozempic-epar-product-information_en.pdf. Accessed July 2022
  • 11 Novo Nordisk. Ozempic (semaglutide) 0.25 mg, 0.5 mg, 1 mg and 2 mg solution for injection in pre-filled pen. Prescribing Information. 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209637s009lbl.pdf. Accessed July 2022
  • 12 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
  • 13 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
  • 14 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
  • 15 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
  • 16 Rodbard HW, Lingvay I, Reed J. et al. Semaglutide added to basal insulin in type 2 diabetes (SUSTAIN 5): A randomized, controlled trial. J Clin Endocrinol Metab 2018; 103: 2291-2301
  • 17 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; 6: 275-286
  • 18 Lingvay I, Catarig AM, Frias JP. et al. Efficacy and safety of once-weekly semaglutide versus daily canagliflozin as add-on to metformin in patients with type 2 diabetes (SUSTAIN 8): A double-blind, phase 3b, randomised controlled trial. Lancet Diabetes Endocrinol 2019; 7: 834-844
  • 19 Zinman B, Bhosekar V, Busch R. et al. Semaglutide once weekly as add-on to SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): A randomised, placebo-controlled trial. Lancet Diabetes Endocrinol 2019; 7: 356-367
  • 20 Capehorn MS, Catarig AM, Furberg JK. et al. Efficacy and safety of once-weekly semaglutide 1.0mg vs once-daily liraglutide 1.2mg as add-on to 1-3 oral antidiabetic drugs in subjects with type 2 diabetes (SUSTAIN 10). Diabetes Metab 2020; 46: 100-109
  • 21 Marso SP, Bain SC, Consoli A. et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med 2016; 375: 1834-1844
  • 22 Blonde L, Khunti K, Harris SB. et al. Interpretation and impact of real-world clinical data for the practicing clinician. Adv Ther 2018; 35: 1763-1774
  • 23 Yale JF, Catarig AM, Grau K. et al. Use of once-weekly semaglutide in patients with type 2 diabetes in routine clinical practice: results from the SURE Canada multicenter, prospective, observational study. Diabetes Obes Metab 2021; 23: 2269-2278
  • 24 Rajamand Ekberg N, Bodholdt U, Catarig A-M. et al. Real-world use of once-weekly semaglutide in patients with type 2 diabetes: Results from the SURE Denmark/Sweden multicentre, prospective, observational study. Prim Care Diabetes 2021; 15: 871-878
  • 25 Rudofsky G, Catarig AM, Favre L. et al. Real-world use of once-weekly semaglutide in patients with type 2 diabetes: Results from the SURE Switzerland multicentre, prospective, observational study. Diabetes Res Clin Pract 2021; 178: 108931
  • 26 Holmes P, Bell HE, Bozkurt K, Catarig AM. et al. Real-world use of once-weekly semaglutide in type 2 diabetes: Results from the SURE UK multicentre, prospective, observational study. Diabetes Ther 2021; 12: 2891-2905
  • 27 World Medical Association. World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA 2013; 310: 2191-2194
  • 28 International and Society for Pharmacoepidemiology. Guidelines for Good Pharmacoepidemiology Practices (GPP). Revision 3, June, 2015. https://www.pharmacoepi.org/resources/policies/guidelines-08027/. Accessed July 2022
  • 29 Yale JF, Bodholdt U, Catarig AM. et al. Real-world use of once-weekly semaglutide in patients with type 2 diabetes: Pooled analysis of data from four SURE studies by baseline characteristic subgroups. BMJ Open Diabetes Res Care 2022; 10: e002619
  • 30 Wilke T, Picker N, Mueller S. et al. Real-world insulin therapy in German type 2 diabetes mellitus patients: patient characteristics, treatment patterns, and insulin dosage. Diabetes Metab Syndr Obes 2019; 12: 1225–1237. Erratum in: Diabetes Metab Syndr Obes 2019; 12: 1397
  • 31 Eberle C, Stichling S.. Impact of COVID-19 lockdown on glycemic control in patients with type 1 and type 2 diabetes mellitus: A systematic review. Diabetol Metab Syndr 2021; 13: 95