Barriers and new opportunities in developing effective therapies for diabetic neuropathy: International expert consensus recommendations

C Brock; H Andersen; A C Alibegovic; S T Andersen; L J Andreasen; M H Charles; D H Christensen; A M Drewes; M-A Gall; S S Gylfadottir; C S Hansen; S K Hecquet; T S Jensen; P Karlsson; L B Knudsen; C B Lobato; H Kufaishi; H Maalmi; H I Mizrak; K B Nilsen; B A Perkins; J Røikjer; P Rossing; J Rungby; J Rømer; A Stouge; K Sulek; E Søfteland; A A Tahrani; A J Terkelsen; S Tesfaye; A Wegeberg; T Åkerström; B Brock; R Pop-Busui

doi:10.1016/j.diabres.2025.112010

Barriers and new opportunities in developing effective therapies for diabetic neuropathy: International expert consensus recommendations

Diabetes Res Clin Pract. 2025 Mar:221:112010. doi: 10.1016/j.diabres.2025.112010. Epub 2025 Jan 22.

Authors

C Brock¹, H Andersen², A C Alibegovic³, S T Andersen⁴, L J Andreasen⁵, M H Charles⁶, D H Christensen⁷, A M Drewes¹, M-A Gall³, S S Gylfadottir⁸, C S Hansen⁹, S K Hecquet⁹, T S Jensen¹⁰, P Karlsson¹¹, L B Knudsen¹², C B Lobato¹³, H Kufaishi⁹, H Maalmi¹⁴, H I Mizrak⁹, K B Nilsen¹⁵, B A Perkins¹⁶, J Røikjer¹⁷, P Rossing¹⁸, J Rungby¹⁸, J Rømer³, A Stouge², K Sulek¹⁸, E Søfteland¹⁹, A A Tahrani²⁰, A J Terkelsen²¹, S Tesfaye²², A Wegeberg²³, T Åkerström⁵, B Brock²⁴, R Pop-Busui²⁵

Affiliations

¹ Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; Steno Diabetes Center North Denmark, Aalborg University Hospital, Aalborg, Denmark; Mech-Sense, Department of Gastroenterology & Hepatology, Aalborg University Hospital, Aalborg, Denmark.
² Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.
³ Clinical Development and Project Leadership, Novo Nordisk A/S, Søborg, Denmark.
⁴ Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.
⁵ Diabetes Pharmacology, Novo Nordisk A/S, Denmark.
⁶ Steno Diabetes Center Aarhus, Aarhus, Denmark.
⁷ Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark; Department of Clinical Epidemiology, Aarhus University Hospital, Denmark.
⁸ Department of Neurology, Aarhus University Hospital, Aarhus, Denmark; Danish Pain Research Center, Health Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
⁹ Complications Research, Steno Diabetes Center Copenhagen, Herlev, Denmark.
¹⁰ Danish Pain Research Center, Health Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
¹¹ Danish Pain Research Center, Health Department of Clinical Medicine, Aarhus University, Aarhus, Denmark; Core Centre for Molecular Morphology, Section for Stereology for Microscopy, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
¹² Chief Scientific Advisor Office, Research & Early Development, Novo Nordisk A/S, Denmark.
¹³ Section of Endocrinology, Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
¹⁴ Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
¹⁵ Section for Clinical Neurophysiology, Department of Neurology, Oslo University Hospital, Oslo, Norway.
¹⁶ Division of Endocrinology and Metabolism, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
¹⁷ Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; Steno Diabetes Center North Denmark, Aalborg University Hospital, Aalborg, Denmark.
¹⁸ Steno Diabetes Center Copenhagen, Herlev, Denmark and Department of Clinical Medicine, University of Copenhagen, Denmark.
¹⁹ Department of Medicine, Haukeland University Hospital, Bergen, Norway.
²⁰ Clinical Development and Project Leadership, Novo Nordisk A/S, Søborg, Denmark; University of Birmingham, Department of Metabolism and Systems Science, Birmingham, UK.
²¹ Department of Neurology, Aarhus University Hospital, Aarhus, Denmark; Complications Research, Steno Diabetes Center Copenhagen, Herlev, Denmark.
²² Diabetes Research Unit, Sheffield Teaching Hospitals and the University of Sheffield, Sheffield, UK.
²³ Mech-Sense, Department of Gastroenterology & Hepatology, Aalborg University Hospital, Aalborg, Denmark.
²⁴ University of Birmingham, Department of Metabolism and Systems Science, Birmingham, UK. Electronic address: Cbrock@dcm.aau.dk.
²⁵ Department of Medicine, Division of Endocrinology, Diabetes and Clinical Nutrition, Oregon Health & Science University, Portland USA.

PMID: 39855602
DOI: 10.1016/j.diabres.2025.112010

Abstract

Background: Diabetic neuropathy (DN) affects up to half of individuals with type 1 and type 2 diabetes. Despite evidence that improving metabolic and cardiovascular health can slow its progression, DN remains a significant clinical challenge due to the lack of disease-modifying therapies and effective pain management strategies. This consensus aimed to identify gaps and recommend strategies to address these challenges.

Method: A workshop, initiated by Steno Diabetes Centre Copenhagen and the Danish Diabetes and Endocrinology Academy, conducted a gap analysis based on insights from clinical studies, observational cohorts, and clinical practice. Online invitations targeted experienced clinicians, researchers, and drug developers committed to improving DN treatment through innovative clinical trials. Thirty-five participants from six countries reached consensus via a Delphi process on key steps to advance DN therapy.

Result: Four critical barriers and needs were addressed: (1) Translating bench research to clinical practice, (2) Enhancing clinical trial design, (3) Improving outcome measures, and (4) Identifying effective treatments for painful DN.

Conclusion: Successful interventional trials require robust outcome measures to capture clinically meaningful changes in DN phenotypes, providing the basis for developing effective, disease-modifying treatments.

Keywords: Consensus; Diabetic neuropathy; Drug development; Optimized design and outcomes; Painful neuropathy.

Publication types

Consensus Development Conference

MeSH terms

Consensus
Delphi Technique
Diabetes Mellitus, Type 2 / complications
Diabetic Neuropathies* / therapy
Humans