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A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy
Sponsor: Novo Nordisk A/S
Summary
This study will look at the effects of CagriSema in people with both type 2 diabetes and painful diabetic peripheral neuropathy, compared to placebo. Participants will either get an active medicine or a "dummy" medicine (placebo). Which treatment participants get is decided by chance. In this study the active, investigational medicine is called CagriSema. Doctors cannot yet prescribe CagriSema. For each participant, the study will last for about 10 months.
Official title: Efficacy and Safety of co Administered Cagrilintide and Semaglutide (CagriSema) Once Weekly Versus Placebo in Participants With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
142
Start Date
2025-01-29
Completion Date
2026-08-21
Last Updated
2025-12-05
Healthy Volunteers
No
Interventions
CagriSema (Cagrilintide B and Semaglutide I)
Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)
Placebo matched to Cagrilintide B and Placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
Locations (54)
eStudySite
La Mesa, California, United States
Linda Vista Health Care Ctr
San Diego, California, United States
My Preferred Research
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Foot & Ankle Center of Illinois
Springfield, Illinois, United States
Velocity Clinical Research Rockville
Rockville, Maryland, United States
Amicis Centers of Clinical Research
St Louis, Missouri, United States
DM Clinical - CyFair
Albuquerque, New Mexico, United States
Southgate Medical Group, LLP
West Seneca, New York, United States
Piedmont Healthcare/Research
Statesville, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Oregon Health & Science University
Portland, Oregon, United States
Clinical Res Collaborative
Cumberland, Rhode Island, United States
DM Clinical - CyFair
Houston, Texas, United States
Radiance Clinical Research
Lampasas, Texas, United States
DM Clinical - CyFair
San Antonio, Texas, United States
DM Clinical Research
San Antonio, Texas, United States
Velocity Clinical Research Portsmouth
Suffolk, Virginia, United States
G.A. Research Associates Ltd.
Moncton, New Brunswick, Canada
Centricity Research Brampton
Brampton, Ontario, Canada
Centricity Clinical Research Burlington
Burlington, Ontario, Canada
Centricity Research Etobicoke
Etobicoke, Ontario, Canada
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario, Canada
Diabetes Heart Research Centre
Toronto, Ontario, Canada
Ctr de Med Metab de Lanaudiere
Terrebonne, Quebec, Canada
Aarhus Universitetshospital, Steno Diabetes Center Aarhus
Aarhus N, Denmark
Steno Diabetes Center Nordjylland
Gistrup, Denmark
Steno Diabetes Center Copenhagen
Herlev, Denmark
Kolding Sygehus Karkirurgi
Kolding, Denmark
Steno Diabetes Center Odense
Odense C, Denmark
Les Hopitaux de Chartres-Hopital Louis Pasteur
Le Coudray, France
Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-1
Le Creusot, France
Aphp-Hopital La Pitie Salpetriere-1
Paris, France
Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-1
Pessac, France
Centre de Recherche Clinique Portes Du Sud
Vénissieux, France
Haukeland Universitetssykehus
Bergen, Norway
Sykehuset Innlandet HF Hamar
Hamar, Norway
Oslo universitetssykehus, Ullevål
Oslo, Norway
Stavanger Universitetssykehus, Helse Stavanger HF
Stavanger, Norway
Hospital Nisa Sevilla Aljarafe
Castilleja de La Cuesta. Sevilla, Andalusia, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
Hospital Vall d'Hebron
Barcelona, Spain
Hospital Universitario de la Princesa
Madrid, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Hospital Infanta Luisa
Seville, Spain
Tameside General Hospital
Ashton-under-Lyne, Greater Manchester, United Kingdom
Ipswich Hospital - Diabetes
Ipswich, United Kingdom
Aintree University Hospital
Liverpool, United Kingdom
St Pancras Clinical Research
London, United Kingdom
Kings College Hospital - Renal
London, United Kingdom
Manchester Royal Infirmary - Diabetes
Manchester, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom