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