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Lo studio clinico NCT06323174 (REIMAGINE 1) per Diabete di tipo 2 è attivo, non in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Novo NordiskA Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise (REIMAGINE 1)
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT06323174 (REIMAGINE 1) è uno studio interventistico di Fase III volto a esaminare il trattamento per Diabete di tipo 2, attualmente attivo, non in arruolamento. Avviato il 19 marzo 2024, prevede di arruolare 180 partecipanti. Sotto la guida di Novo Nordisk, dovrebbe concludersi entro il 26 dicembre 2025. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 17 settembre 2025.
Sommario breve
This study will look at how much CagriSema helps participants 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. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year.
Titolo ufficiale
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 Inadequately Controlled on Diet and Exercise
Condizioni
Diabete di tipo 2Altri ID dello studio
- REIMAGINE 1
- NN9388-4895
- 2022-502677-42 (Altro identificativo) (European Medical Agency (EMA))
- U1111-1283-0404 (Altro identificativo) (World Health Organization (WHO))
Numero NCT
Data di inizio (effettiva)
2024-03-19
Ultimo aggiornamento pubblicato
2025-09-17
Data di completamento (stimata)
2025-12-26
Arruolamento (previsto)
180
Tipo di studio
Interventistico
FASE
Fase III
Stato
Attivo, non in arruolamento
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Quadruplo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Comparatore attivoCagriSema Dose 2 Participants will receive once-weekly subcutaneous (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. |
Comparatore placeboPlacebo Dose 2 Participants will receive once-weekly s.c injection of placebo matched to Cagrisema (cagrilintide and semaglutide) dose 2 for 40 weeks. | PLACEBO Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously. |
Comparatore attivoCagrisema 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. |
Comparatore placeboPlacebo Dose 1 Participants will receive once-weekly s.c injection of placebo matched to Cagrisema (cagrilintide and semaglutide) dose 1 for 40 weeks. | PLACEBO Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change in glycated haemoglobin (HbA1c) | Measured as percentage (%)-points. | From baseline (week 0) to end of treatment (week 40) |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Relative change in body weight | Measured in %. | From baseline (week 0) to end of treatment (week 40) |
Number of participants who achieve greater than or equal to (>=) 10% body weight reduction | Measured as count of participants. | From baseline (week 0) to end of treatment (week 40) |
Number of participants who achieve >=15% body weight reduction | Measured as count of participants. | From baseline (week 0) to end of treatment (week 40) |
Number of participants who achieve HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol]) | Measured as count of participants. | At end of treatment (week 40) |
Number of participants who achieve HbA1c target values of less than or equal to (<=) 6.5% (<= 48 mmol/mol) | Measured as count of participants. | At end of treatment (week 40) |
Change in Fasting Plasma Glucose (FPG) | Measured in millimoles per liter (mmol/L). | From baseline (week 0) to end of treatment (week 40) |
Number of participants who achieve >=5% body weight reduction | Measured as count of participants. | From baseline (week 0) to end of treatment (week 40) |
Number of participants who achieve >=20% body weight reduction | Measured as count of participants. | From baseline (week 0) to end of treatment (week 40) |
Change in waist circumference | Measured in centimeters (cm). | From baseline (week 0) to end of treatment (week 40) |
Change in systolic blood pressure (SBP) | Measured in millimeters of mercury (mmHg). | From baseline (week 0) to end of treatment (week 40) |
Change in diastolic blood pressure (DBP) | Measured in mmHg. | From baseline (week 0) to end of treatment (week 40) |
Ratio to baseline in high sensitivity C-reactive protein (hsCRP) | Measured as ratio. | From baseline (week 0) to end of treatment (week 40) |
Ratio to baseline in lipids: Total cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 40) |
Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 40) |
Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 40) |
Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 40) |
Ratio to baseline in lipids: Triglycerides | Measured as ratio. | From baseline (week 0) to end of treatment (week 40) |
Ratio to baseline in lipids: Free fatty acids | Measured as ratio. | From baseline (week 0) to end of treatment (week 40) |
Ratio to baseline in lipids: Non-HDL cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 40) |
Number of participants who achieve type 2 diabetes (T2D) remission (HbA1c <6.5% and no antidiabetic medication) | Measured as count of participants. | At end of study (week 52) |
Ratio to baseline in oral glucose tolerance test (OGTT) based oral glucose disposition index (DIo) | Measured as ratio. | From baseline (week 0) to end of treatment (week 40) |
Change in experienced level of energy as measured by the SF-36v2 Health Survey Acute (SF-36v2) Vitality score | Measured as score points. SF-36v2 Acute measures Health-Related Quality of Life (HRQoL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10.
Higher scores indicate better functional health and well-being. The vitality score range is from 25.6 to 69.1. | From baseline (week 0) to end of treatment (week 40) |
Change in SF-36v2 score: Physical Component Summary score | Measured as score points. SF-36v2 Acute measures HRQoL. The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The score range for physical component summary is 6.1 to 79.7. | From baseline (week 0) to end of treatment (week 40) |
Change in SF-36v2 score: Mental Component Summary score | Measured as score points. SF-36v2 Acute measures HRQoL. The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The score range for mental component summary score is -3.8 to 78.7. | From baseline (week 0) to end of treatment (week 40) |
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score | Measured as score points. DTSQs measures treatment satisfaction and diabetes-specific quality of life. The measure consists of 8 items yielding 1 global score and 2 single item scores. Higher scores on the global score indicate greater satisfaction with treatment. Lower scores on the single-item scores indicate BG levels closer to the ideal, while higher scores indicate problems. Single-item scores (score range): Perceived frequency of hyperglycaemia (0-6), Perceived frequency of hypoglycaemia (0-6). Global score (score range): Total Treatment Satisfaction (0-36). | From baseline (week 0) to end of treatment (week 40) |
Change in leptin | Measured in nanograms per milliliter (ng/mL). | From baseline (week 0) to end of treatment (week 40) |
Change in soluble leptin receptor | Measured in ng/mL. | From baseline (week 0) to end of treatment (week 40) |
Number of Treatment Emergent Adverse Events (TEAEs) | Measured as count of events. | From baseline (week 0) to end of treatment +7 weeks (week 47) |
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol (54 milligrams per deciliter [mg/dL]), confirmed by blood glucose (BG) meter | Measured as count of episodes. | From baseline (week 0) to end of treatment +7 weeks (week 47) |
Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold | Measured as count of episodes. | From baseline (week 0) to end of treatment + 7 weeks (week 47) |
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Male or female
- Age 18 years or above at the time of signing the informed consent
- Diagnosed with type 2 diabetes >=30 days before screening
- HbA1c 7.0-9.5 percent (53-80 millimoles per mole [mmol/mol]) (both inclusive) as determined by central laboratory at screening
- Body mass index (BMI) >=23 kilograms 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
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method
- Renal impairment with estimated Glomerular Filtration Rate less than 30 milliliter per minute per 1.73 square meter (ml/min/1.73 m^2) as determined by central laboratory at screening
- Treatment with any medication for the indication of diabetes or obesity within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed
- History of use of any injectable therapy for diabetes or obesity. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus 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
Novo Nordisk134 studi clinici attivi da esplorareNessun dato di contatto
47 Centri dello studio in 7 paesi
Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, 24127, Italy
Policlinico Mater Domini Università di Catanzaro, Catanzaro, 88100, Italy
IRCCS Ospedale San Raffaele Milano, Milan, 20132, Italy
Azienda Ospealiero Universitaria Policlinico Umberto I, Roma, 00161, Italy
California
Nat Res Inst Huntington Park, Huntington Park, California, 90255, United States
Valley Clinical Trials, Inc., Northridge, California, 91325, United States
Southern California Dermatology, Santa Ana, California, 92701, United States
Florida
Encore Medical Research LLC, Hollywood, Florida, 33024, United States
Headlands Research Orlando, Orlando, Florida, 32819, United States
Encore Medical Research of Weston, Weston, Florida, 33331, United States
Kansas
Alliance for Multispec Res, Newton, Kansas, 67114, United States
Massachusetts
Brigham & Women's Hospital, Boston, Massachusetts, 02115, United States
Michigan
Arcturus HC PLC Troy Med Res, Troy, Michigan, 48098, United States
New York
Southgate Medical Group, LLP, West Seneca, New York, 14224, United States
Tennessee
Holston Medical Group, Kingsport, Tennessee, 37660, United States
Texas
Headlands Research Brownsville, Brownsville, Texas, 78526, United States
Velocity Clinical Res-Dallas, Dallas, Texas, 75230, United States
Northeast Clinical Research of San Antonio, San Antonio, Texas, 78233, United States
Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States
Sugar Lakes Family Practice PA, Sugar Land, Texas, 77479, United States
Valley Diab. & Endo Comp Ctr, Weslaco, Texas, 78596, United States
Virginia
TPMG Clinical Research, Newport News, Virginia, 23606, United States
Beijing Municipality
Chinese People's Liberation Army General Hospital-Endocrinology, Beijing, Beijing Municipality, 100853, China
Jiangsu
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology, Nanjing, Jiangsu, 210011, China
The Affiliated Hospital of Jiangsu University-Endocrinology, Zhenjiang, Jiangsu, 212001, China
Shandong
Jinan Central Hospital, Ji'Nan, Shandong, 250000, China
Jinan Central Hospital Affiliated to Shandong University, Jinan, Shandong, 250000, China
Hajdú-Bihar
Belinus Bt., Debrecen, Hajdú-Bihar, 4025, Hungary
Szabolcs-Szatmar Varmegye
Borbánya Praxis E.Ü. Kft., Nyíregyháza, Szabolcs-Szatmar Varmegye, 4405, Hungary
Szent Margit Rendelőintézet Nonprofit Kft., Budapest, 1032, Hungary
PVN Kutato Kft., Budapest, 1102, Hungary
Podkarpackie Voivodeship
Centrum Medyczne Medyk Sp. z o.o., Rzeszów, Podkarpackie Voivodeship, 35-055, Poland
Osteo-Medic s.c. A. Racewicz, J. Supronik, Bialystok, 15-351, Poland
Renew Clinic Sp. z o.o., Bialystok, 15-797, Poland
Centrum Terapii Współczesnej J.M. Jasnorzewska S.K.A., Lodz, 90-338, Poland
NBR Polska Tomasz Klodawski, Warsaw, 00-710, Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji, Warsaw, 02-507, Poland
Velocity Nova Sp. z o.o., Zamość, 22-400, Poland
King Abdulaziz Hospital-Al Ahsa-National Guard, Al Ahsa, 36428, Saudi Arabia
National Guard Hospital - Jeddah, Jeddah, 21423, Saudi Arabia
King Fahad Medical City, Riyadh, 11525, Saudi Arabia
King Khaled University Hospital,King Saud Univ. Med. City, Riyadh, 12372, Saudi Arabia
King Salman Bin Abdulaziz Hospital, Riyadh, 12769, Saudi Arabia
CHC Zvezdara, Clinical department for endocrinology, Belgrade, 11000, Serbia
Clinical Hospital Center Bezanijska Kosa, Belgrade, 11080, Serbia
Clinical Hospital Centre Zemun, Belgrade, 11080, Serbia
Policlinic for diabetes, Zaječar, 19000, Serbia