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A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Once-daily Basal Insulin With or Without Metformin
Sponsor: Novo Nordisk A/S
Summary
This study will look at how much CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participant will get either CagriSema or "dummy" medicine and which treatment they get is decided by chance. Participant will take the study medicine together with their current diabetes medicine (once-daily insulin with or without metformin). For each participant, the study will last for about one year.
Official title: Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4 mg/2.4 mg and 1.0 mg/1.0 mg Once Weekly Versus Placebo in Participants With Type 2 Diabetes as Add on to Once-daily Basal Insulin With or Without Metformin
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
274
Start Date
2024-03-26
Completion Date
2025-10-23
Last Updated
2026-09-09
Healthy Volunteers
No
Conditions
Interventions
Cagrilintide
Participants will receive once-weekly cagrilintide subcutaneously.
Semaglutide
Participants will receive once-weekly semaglutide subcutaneously.
Placebo
Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously.
Locations (61)
Valley Research
Fresno, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Bioclinical Research Alliance
Miami, Florida, United States
Solaris Clinical Research
Meridian, Idaho, United States
Iowa Diab & Endo Res Center
West Des Moines, Iowa, United States
Alliance for Multispec Res
Newton, Kansas, United States
Endo and Metab Consultants
Rockville, Maryland, United States
Elite Research Center
Flint, Michigan, United States
Palm Research Center Inc.
Las Vegas, Nevada, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Holston Medical Group
Kingsport, Tennessee, United States
Clinical Research Associates
Nashville, Tennessee, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
Synergy Groups Medical
Houston, Texas, United States
PlanIt Research, PLLC
Houston, Texas, United States
Simcare Medical Research, LLC
Sugar Land, Texas, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
TPMG Clinical Research
Newport News, Virginia, United States
Chinese People's Liberation Army General Hospital-Endocrinology
Beijing, Beijing Municipality, China
Huaihe Hospital of Henan University-Endocrinology
Kaifeng, Henan, China
Huaihe Hospital of Henan University
Kaifeng, Henan, China
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University_Nanjing
Nanjing, Jiangsu, China
The Affiliated Hospital of Jiangsu University-Endocrinology
Zhenjiang, Jiangsu, China
Jinan Central Hospital
Ji'nan, Shandong, China
Jinan Central Hospital
Jinan, Shandong, China
Shanghai Pudong New Area People's Hospital-Endocrinology
Shanghai, Shanghai Municipality, China
Manda Memorial Hospital_Internal Medicine
Sapporo-shi, Hokkaido, Hokkaido, Japan, Japan
Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
Yamato-shi, Kanagawa, Japan
Kumanomae Nishimura Naika Clinic_Internal Medicine
Arakawa-ku, Tokyo, Japan
Akaicho Clinic
Chiba-shi, Chiba, Japan
Futata Tetsuhiro Clinic Meinohama_Internal medicine
Fukuoka-shi, Fukuoka, Japan
Kunisaki Makoto Clinic
Fukuoka-shi, Fukuoka, Japan
Sasaki Internal Medicine
Hokkaido, Japan
Naka Kinen Clinic_Internal medicine
Ibaraki, Japan
H.E.C Science Clinic_Internal Medicine, Diabetes
Kanagawa, Japan
H.E.C Science Clinic
Kanagawa, Japan
Kyoto University Hospital_Department of Diabetes, Endocr
Kyoto-shi, Kyoto, Japan
Minami Akatsuka Clinic_internal medicine
Mito-shi, Ibaraki, Japan
Tokyo-Eki Center-building Clinic_Internal Medicine
Tokyo, Japan
Tokyo-Eki Center-building Clinic
Tokyo, Japan
Fukuwa Clinic_Internal Medicine
Tokyo, Japan
Kato Clinic of Internal Medicine_Internal Medicine
Tokyo, Japan
Healthcare centre Zvezdara
Belgrade, RS, Serbia
Healthcare centre Kragujevac
Kragujevac, RS, Serbia
University Clinical Centre Nis
Niš, RS, Serbia
Healthcare centre Nis
Niš, RS, Serbia
Policlinic for diabetes
Zaječar, Serbia
MOMED, s.r.o
Kráľovský Chlmec, Slovakia
DIA - KONTROL s.r.o.
Levice, Slovakia
SIN AZUCAR s.r.o.
Malacky, Slovakia
ENRIN, s.r.o.
Rimavská Sobota, Slovakia
LUDIA, s. r. o.
Spišská Nová Ves, Slovakia
Oraderumaz (Pty) Ltd
Bloemfontein, Free State, South Africa
Hemant Makan
Johannesburg, Gauteng, South Africa
Lenasia Clinical Trial Centre
Lenasia, Gauteng, South Africa
Prinshof Medical Campus
Pretoria, Gauteng, South Africa
Clinical Trial Systems (CTC)
Pretoria, Gauteng, South Africa
Dr Vawda's site
Durban, KwaZulu-Natal, South Africa
Ashmed Medi-Centre
Cape Town, Western Cape, South Africa
Dr Noeth's Practice
Pretoria, South Africa