Phase
Condition
Diabetes And Hypertension
Diabetes Prevention
Diabetes Mellitus, Type 2
Treatment
Cagrilintide
Semaglutide
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female (sex at birth).
Age 18 years or above at the time of signing the informed consent.
Diagnosed with type 2 diabetes mellitus ≥180 days before screening.
On stable once-daily dose of basal insulin (minimum of 0.25 units per kilogram perday (U/kg/day) or 20 U/day) alone or in combination with metformin (at effective ormaximum tolerated dose as judged by the investigator) for 90 days prior toscreening.
Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole [mmol/mol]) (both inclusive) as determined by central laboratory at screening.
Body Mass Index (BMI) greater than or equal to 25 kilogram per square meter (kg/m^2)at screening. BMI will be calculated in the electronic case report form (eCRF) basedon height and body weight at screening.
Exclusion
Exclusion Criteria:
Female who is pregnant, breast-feeding or intends to become pregnant or is ofchildbearing potential and not using a highly effective contraceptive method.
Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) as determined bycentral laboratory at screening.
Treatment with any medication for the indication of diabetes or obesity other thanstated in the inclusion criteria within 90 days before screening.
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verifiedby an eye examination performed within 90 days before screening or in the periodbetween screening and randomisation. Pharmacological pupil-dilation is a requirementunless using a digital fundus photography camera specified for non-dilatedexamination.
Known hypoglycaemia unawareness as indicated by the investigator according toClarke's questionnaire question 8.
Recurrent severe hypoglycaemic episodes within the last year as judged by theinvestigator.
Study Design
Connect with a study center
Chinese People's Liberation Army General Hospital
Beijing, Beijing 100853
ChinaSite Not Available
Chinese People's Liberation Army General Hospital-Endocrinology
Beijing, Beijing 100853
ChinaSite Not Available
Huaihe Hospital of Henan University
Kaifeng, Henan 475000
ChinaSite Not Available
Huaihe Hospital of Henan University-Endocrinology
Kaifeng, Henan 475000
ChinaSite Not Available
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
Nanjing, Jiangsu 210011
ChinaSite Not Available
The Second Affiliated Hospital of Nanjing Medical University_Nanjing
Nanjing, Jiangsu 210011
ChinaSite Not Available
The Affiliated Hospital of Jiangsu University-Endocrinology
Zhenjiang, Jiangsu 212001
ChinaSite Not Available
The Affiliated Hospital of Jiangsu University_Zhenjiang
Zhenjiang, Jiangsu 212001
ChinaSite Not Available
Jinan Central Hospital
Ji'nan, Shandong 250013
ChinaSite Not Available
Shanghai Pudong New Area People's Hospital
Shanghai, Shanghai 201200
ChinaSite Not Available
Shanghai Pudong New Area People's Hospital-Endocrinology
Shanghai, Shanghai 201200
ChinaSite Not Available
Manda Memorial Hospital
Sapporo-shi, Hokkaido, Hokkaido, Japan 060-0062
JapanSite Not Available
Tsuruma Kaneshiro Diabetes Clinic
Yamato-shi, Kanagawa 242-0004
JapanSite Not Available
Kumanomae Nishimura Internal Medical Clinic
Arakawa-ku, Tokyo, 116-0012
JapanSite Not Available
Akaicho Clinic
Chiba-shi, Chiba, 260-0804
JapanSite Not Available
Futata Tetsuhiro Clinic Meinohama
Fukuoka-shi, Fukuoka, 819-0006
JapanSite Not Available
Kunisaki Makoto Clinic
Fukuoka-shi, Fukuoka, 819-0168
JapanSite Not Available
Sasaki Hospital Internal Medicine
Hokkaido, 062-0007
JapanActive - Recruiting
Sasaki Internal Medicine
Hokkaido, 062-0007
JapanSite Not Available
Naka Kinen Clinic
Ibaraki, 311-0113
JapanSite Not Available
H.E.C Science Clinic
Kanagawa, 235-0045
JapanSite Not Available
Kyoto University Hospital
Kyoto-shi, Kyoto, 606-8507
JapanSite Not Available
Minami Akatsuka Clinic
Mito-shi, Ibaraki, 311-4153
JapanSite Not Available
Fukuwa Clinic
Tokyo, 104-0031
JapanSite Not Available
Kato Clinic of Internal Medicine
Tokyo, 125-0054
JapanSite Not Available
Tokyo-Eki Center-building Clinic
Tokyo, 103-0027
JapanSite Not Available
Healthcare centre Zvezdara
Belgrade, RS 11050
SerbiaSite Not Available
Healthcare centre Kragujevac
Kragujevac, RS 34000
SerbiaSite Not Available
Healthcare centre Nis
Nis, RS 18000
SerbiaSite Not Available
University Clinical Centre Nis
Nis, RS 18 000
SerbiaSite Not Available
Policlinic for diabetes
Zajecar, 19000
SerbiaSite Not Available
MOMED, s.r.o
Kralovsky Chlmec, 077 01
SlovakiaSite Not Available
DIA - KONTROL s.r.o.
Levice, 93401
SlovakiaSite Not Available
SIN AZUCAR s.r.o.
Malacky, 901 01
SlovakiaSite Not Available
ENRIN, s.r.o.
Rimavska Sobota, 979 01
SlovakiaSite Not Available
LUDIA, s.r.o.
Spisska Nova Ves, 05201
SlovakiaSite Not Available
Oraderumaz (Pty) Ltd
Bloemfontein, Free State 9301
South AfricaSite Not Available
Vuyo Clinical Research
Bloemfontein, Free State 9323
South AfricaSite Not Available
Lenasia Clinical Trial Centre
Lenasia, Gauteng 1827
South AfricaSite Not Available
Clinical Trial Systems (CTC)
Pretoria, Gauteng 0186
South AfricaSite Not Available
Prinshof Medical Campus
Pretoria, Gauteng 0002
South AfricaSite Not Available
Ashmed Medi-Centre
Cape Town, Western Cape 7760
South AfricaSite Not Available
Valley Clinical Trials, Inc.
Northridge, California 91325
United StatesSite Not Available
Bioclinical Research Alliance
Miami, Florida 33155
United StatesSite Not Available
Solaris Clinical Research
Meridian, Idaho 83646
United StatesSite Not Available
Iowa Diab & Endo Res Center
West Des Moines, Iowa 50266
United StatesSite Not Available
Alliance for Multispec Res
Newton, Kansas 67114
United StatesSite Not Available
Elite Research Center
Flint, Michigan 48532
United StatesSite Not Available
Palm Research Center Inc.
Las Vegas, Nevada 89128
United StatesSite Not Available
University of North Carolina
Chapel Hill, North Carolina 27517
United StatesSite Not Available
Clinical Research Associates
Nashville, Tennessee 37203
United StatesSite Not Available
Velocity Clinical Res-Dallas
Dallas, Texas 75230
United StatesSite Not Available
PlanIt Research, PLLC
Houston, Texas 77079
United StatesSite Not Available
Synergy Groups Medical
Houston, Texas 77061
United StatesSite Not Available
Manassas Clinical Research Center
Manassas, Virginia 20110
United StatesSite Not Available
TPMG Clinical Research
Newport News, Virginia 23606
United StatesSite Not Available
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