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
NCT ID: NCT06323161
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
274 participants
INTERVENTIONAL
2024-03-26
2025-10-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CagriSema Dose 1
Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 32 weeks.
Cagrilintide
Participants will receive once-weekly cagrilintide subcutaneously.
Semaglutide
Participants will receive once-weekly semaglutide subcutaneously.
CagriSema Dose 2
Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 16-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 24 weeks.
Cagrilintide
Participants will receive once-weekly cagrilintide subcutaneously.
Semaglutide
Participants will receive once-weekly semaglutide subcutaneously.
Placebo Dose 1
Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 1 (cagrilintide and semaglutide) for 40 weeks.
Placebo
Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously.
Placebo Dose 2
Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 2 (cagrilintide and semaglutide) for 40 weeks
Placebo
Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 per day (U/kg/day) or 20 U/day) alone or in combination with metformin (at effective or maximum tolerated dose as judged by the investigator) for 90 days prior to screening.
* 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) based on height and body weight at screening.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
* Known hypoglycaemia unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
* Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
Exclusion Criteria
* Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2) as determined by central laboratory at screening.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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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
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
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
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 Affiliated to Shandong University
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
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
Kanagawa, , Japan
Kyoto University Hospital
Kyoto-shi, Kyoto, , Japan
Minami Akatsuka Clinic
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
Lenasia Clinical Trial Centre
Lenasia, Gauteng, South Africa
Prinshof Medical Campus
Pretoria, Gauteng, South Africa
Clinical Trial Systems (CTC)
Pretoria, Gauteng, South Africa
Ashmed Medi-Centre
Cape Town, Western Cape, South Africa
Countries
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Other Identifiers
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U1111-1283-0754
Identifier Type: OTHER
Identifier Source: secondary_id
2022-502679-43
Identifier Type: OTHER
Identifier Source: secondary_id
NN9388-7637
Identifier Type: -
Identifier Source: org_study_id
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