protocolSection identificationModule nctId: NCT06323161, orgStudyIdInfo id: NN9388-7637, secondaryIdInfos id: U1111-1283-0754, type: OTHER, domain: World Health Organization (WHO), secondaryIdInfos id: 2022-502679-43, type: OTHER, domain: European Medical Agency (EMA), briefTitle: 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, acronym: REIMAGINE 3, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2025-09-16, completionDateStruct date: 2025-11-04, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 270, type: ESTIMATED, armsInterventionsModule interventions name: Cagrilintide, interventions name: Semaglutide, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in Glycated Haemoglobin (HbA1c), secondaryOutcomes measure: Relative Change in Body Weight, secondaryOutcomes measure: Number of Participants Who Achieve Greater than or Equal to (≥) 10% Body Weight Reduction, secondaryOutcomes measure: Number of Participants Who Achieve ≥15% Body Weight Reduction, secondaryOutcomes measure: Number of Participants Who Achieve HbA1c Target Values of Less than (<) 7.0% (<53 millimole per mole [mmol/mol]), secondaryOutcomes measure: Number of Participants Who Achieve HbA1c Target Values of Less than or Equal to (≤) 6.5% (≤48 mmol/mol), secondaryOutcomes measure: Change in Fasting Plasma Glucose (FPG), secondaryOutcomes measure: Change in Insulin Dose, secondaryOutcomes measure: Number of Participants Who Achieve Insulin Dose Equal to (=) 0 Units, secondaryOutcomes measure: Change in 7-point Self-measured Plasma Glucose (SMPG) Profiles: Mean 7-point profile and Mean postprandial increment (over all meals), secondaryOutcomes measure: Number of Participants Who Achieve ≥5% Body Weight Reduction, secondaryOutcomes measure: Number of Participants Who Achieve ≥20% Body Weight Reduction, secondaryOutcomes measure: Change in Waist Circumference, secondaryOutcomes measure: Change in Systolic Blood Pressure (SBP), secondaryOutcomes measure: Change in Diastolic Blood Pressure (DBP), secondaryOutcomes measure: Ratio to Baseline in High Sensitivity C-reactive Protein (hsCRP), secondaryOutcomes measure: Ratio to Baseline in Lipids: Non-high Density Lipoprotein (Non-HDL) Cholesterol, secondaryOutcomes measure: Ratio to Baseline in Lipids: Triglycerides, secondaryOutcomes measure: Ratio to Baseline in Lipids: Low-Density Lipoprotein (LDL) Cholesterol, secondaryOutcomes measure: Ratio to Baseline in Lipids: Very Low-Density Lipoprotein (VLDL) cholesterol, secondaryOutcomes measure: Ratio to Baseline in Lipids: HDL Cholesterol, secondaryOutcomes measure: Ratio to Baseline in Lipids: Total Cholesterol, secondaryOutcomes measure: Ratio to Baseline in Lipids: Free Fatty Acids, secondaryOutcomes measure: Change in Short Form-36 Version 2.0 Health Survey (SF-36v2): Vitality score, secondaryOutcomes measure: Change in SF-36v2: Physical Component Summary Score, secondaryOutcomes measure: Change in SF-36v2: Mental Component Summary Core, secondaryOutcomes measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, secondaryOutcomes measure: Change in Leptin, secondaryOutcomes measure: Change in Soluble Leptin Receptor, secondaryOutcomes measure: Number of Treatment Emergent Adverse Events (TEAEs), secondaryOutcomes measure: Number of Clinically Significant Hypoglycaemic Episodes (level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose Meter), secondaryOutcomes measure: Number of Clinically Significant Hypoglycaemic Episodes (level 3), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Valley Clinical Trials, Inc., status: RECRUITING, city: Northridge, state: California, zip: 91325, country: United States, geoPoint lat: 34.22834, lon: -118.53675, locations facility: Bioclinical Research Alliance, status: RECRUITING, city: Miami, state: Florida, zip: 33155, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Solaris Clinical Research, status: RECRUITING, city: Meridian, state: Idaho, zip: 83646, country: United States, geoPoint lat: 43.61211, lon: -116.39151, locations facility: Iowa Diab & Endo Res Center, status: RECRUITING, city: West Des Moines, state: Iowa, zip: 50265, country: United States, geoPoint lat: 41.57721, lon: -93.71133, locations facility: Alliance for Multispec Res, status: RECRUITING, city: Newton, state: Kansas, zip: 67114, country: United States, geoPoint lat: 38.04668, lon: -97.34504, locations facility: Elite Research Center, status: RECRUITING, city: Flint, state: Michigan, zip: 48532, country: United States, geoPoint lat: 43.01253, lon: -83.68746, locations facility: Palm Research Center Inc., status: RECRUITING, city: Las Vegas, state: Nevada, zip: 89128, country: United States, geoPoint lat: 36.17497, lon: -115.13722, locations facility: University of North Carolina, status: NOT_YET_RECRUITING, city: Chapel Hill, state: North Carolina, zip: 27517, country: United States, geoPoint lat: 35.9132, lon: -79.05584, locations facility: Clinical Research Associates, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37203, country: United States, geoPoint lat: 36.16589, lon: -86.78444, locations facility: Velocity Clinical Res-Dallas, status: RECRUITING, city: Dallas, state: Texas, zip: 75230, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Synergy Groups Medical, status: RECRUITING, city: Houston, state: Texas, zip: 77061, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: PlanIt Research, PLLC, status: RECRUITING, city: Houston, state: Texas, zip: 77079, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Manassas Clinical Research Center, status: RECRUITING, city: Manassas, state: Virginia, zip: 20110, country: United States, geoPoint lat: 38.75095, lon: -77.47527, locations facility: TPMG Clinical Research, status: RECRUITING, city: Newport News, state: Virginia, zip: 23606, country: United States, geoPoint lat: 37.08339, lon: -76.46965, locations facility: Chinese People's Liberation Army General Hospital, status: NOT_YET_RECRUITING, city: Beijing, state: Beijing, zip: 100853, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: The Second Affiliated Hospital of Nanjing Medical University_Nanjing, status: NOT_YET_RECRUITING, city: Nanjing, state: Jiangsu, zip: 210011, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The Affiliated Hospital of Jiangsu University_Zhenjiang, status: NOT_YET_RECRUITING, city: Zhenjiang, state: Jiangsu, zip: 212001, country: China, geoPoint lat: 32.21086, lon: 119.45508, locations facility: Jinan Central Hospital, status: NOT_YET_RECRUITING, city: Ji'nan, state: Shandong, zip: 250013, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Shanghai Pudong New Area People's Hospital, status: NOT_YET_RECRUITING, city: Shanghai, state: Shanghai, zip: 201200, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Manda Memorial Hospital, status: NOT_YET_RECRUITING, city: Sapporo-shi, Hokkaido, state: Hokkaido, Japan, zip: 060-0062, country: Japan, geoPoint lat: 43.06667, lon: 141.35, locations facility: Tsuruma Kaneshiro Diabetes Clinic, status: RECRUITING, city: Yamato-shi, state: Kanagawa, zip: 242-0004, country: Japan, locations facility: Kumanomae Nishimura Internal Medical Clinic, status: RECRUITING, city: Arakawa-ku, Tokyo, zip: 116-0012, country: Japan, locations facility: Akaicho Clinic, status: RECRUITING, city: Chiba-shi, Chiba, zip: 260-0804, country: Japan, locations facility: Futata Tetsuhiro Clinic Meinohama, status: RECRUITING, city: Fukuoka-shi, Fukuoka, zip: 819-0006, country: Japan, geoPoint lat: 33.6, lon: 130.41667, locations facility: Kunisaki Makoto Clinic, status: RECRUITING, city: Fukuoka-shi, Fukuoka, zip: 819-0168, country: Japan, geoPoint lat: 33.6, lon: 130.41667, locations facility: Sasaki Hospital Internal Medicine, status: RECRUITING, city: Hokkaido, zip: 062-0007, country: Japan, geoPoint lat: 43.41104, lon: 142.88878, locations facility: Naka Kinen Clinic, status: RECRUITING, city: Ibaraki, zip: 311-0113, country: Japan, geoPoint lat: 34.81641, lon: 135.56828, locations facility: H.E.C Science Clinic, status: NOT_YET_RECRUITING, city: Kanagawa, zip: 235-0045, country: Japan, geoPoint lat: 37.58333, lon: 139.91667, locations facility: Minami Akatsuka Clinic, status: RECRUITING, city: Mito-shi, Ibaraki, zip: 311-4153, country: Japan, locations facility: Tokyo-Eki Center-building Clinic, status: RECRUITING, city: Tokyo, zip: 103-0027, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Tokyo-Eki Center-building Clinic, status: NOT_YET_RECRUITING, city: Tokyo, zip: 103-0027, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Fukuwa Clinic, status: RECRUITING, city: Tokyo, zip: 104-0031, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Kato Clinic of Internal Medicine, status: RECRUITING, city: Tokyo, zip: 125-0054, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Healthcare centre Zvezdara, status: NOT_YET_RECRUITING, city: Belgrade, state: RS, zip: 11050, country: Serbia, geoPoint lat: 44.80401, lon: 20.46513, locations facility: Healthcare centre Kragujevac, status: NOT_YET_RECRUITING, city: Kragujevac, state: RS, zip: 34000, country: Serbia, geoPoint lat: 44.01667, lon: 20.91667, locations facility: University Clinical Centre Nis, status: NOT_YET_RECRUITING, city: Nis, state: RS, zip: 18 000, country: Serbia, geoPoint lat: 43.32472, lon: 21.90333, locations facility: Healthcare centre Nis, status: NOT_YET_RECRUITING, city: Nis, state: RS, zip: 18000, country: Serbia, geoPoint lat: 43.32472, lon: 21.90333, locations facility: Policlinic for diabetes, status: NOT_YET_RECRUITING, city: Zajecar, zip: 19000, country: Serbia, geoPoint lat: 43.90358, lon: 22.26405, locations facility: MOMED, s.r.o, status: RECRUITING, city: Kralovsky Chlmec, zip: 077 01, country: Slovakia, geoPoint lat: 48.42336, lon: 21.97944, locations facility: DIA - KONTROL s.r.o., status: RECRUITING, city: Levice, zip: 93401, country: Slovakia, geoPoint lat: 48.21563, lon: 18.60705, locations facility: SIN AZUCAR s.r.o., status: RECRUITING, city: Malacky, zip: 901 01, country: Slovakia, geoPoint lat: 48.43604, lon: 17.02188, locations facility: ENRIN, s.r.o., status: RECRUITING, city: Rimavska Sobota, zip: 979 01, country: Slovakia, geoPoint lat: 48.38284, lon: 20.02239, locations facility: LUDIA, s.r.o., status: RECRUITING, city: Spisska Nova Ves, zip: 05201, country: Slovakia, geoPoint lat: 48.94464, lon: 20.56153, locations facility: Vuyo Clinical Research, status: NOT_YET_RECRUITING, city: Bloemfontein, state: Free State, zip: 9323, country: South Africa, geoPoint lat: -29.12107, lon: 26.214, locations facility: Lenasia Clinical Trial Centre, status: NOT_YET_RECRUITING, city: Lenasia, state: Gauteng, zip: 1827, country: South Africa, geoPoint lat: -26.32052, lon: 27.83564, locations facility: Prinshof Medical Campus, status: NOT_YET_RECRUITING, city: Pretoria, state: Gauteng, zip: 0002, country: South Africa, geoPoint lat: -25.74486, lon: 28.18783, locations facility: Clinical Trial Systems (CTC), status: NOT_YET_RECRUITING, city: Pretoria, state: Gauteng, zip: 0186, country: South Africa, geoPoint lat: -25.74486, lon: 28.18783, locations facility: Ashmed Medi-Centre, status: NOT_YET_RECRUITING, city: Cape Town, state: Western Cape, zip: 7760, country: South Africa, geoPoint lat: -33.92584, lon: 18.42322, hasResults: False