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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1323-3766 | Other Identifier | World Health Organization (WHO) | |
| 2025-522570-37 | Other Identifier | European Medical Agency (EMA) |
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The study is withdrawn due to strategic reasons.
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This study is being done to look at how well a study medicine called CagriSema helps people with diabetes lower their blood sugar. In this study the sponsor will compare two version of CagriSema injected by two different types of injection devices. Which treatment participants get is decided by chance. CagriSema is still being tested in studies and is not yet available for doctors to prescribe. The study will last for about 38 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CagriSema in device 1 + Placebo CagriSema B in device 2 | Experimental | Participants will receive CagriSema in device 1 followed by placebo matched to CagriSema B in device 2 subcutaneously once weekly in a dose escalation manner. |
|
| CagriSema B in device 2 + Placebo CagriSema in device 1 | Experimental | Participants will receive CagriSema B in device 2 followed by placebo matched to CagriSema in device 1 subcutaneously once weekly in a dose escalation manner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CagriSema | Drug | Cagrilintide and Semaglutide will be administered subcutaneously using device 1 or device 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycated haemoglobin (HbA1c) | Measured as percentage-points (%-points). | Baseline to week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly average cagrilintide (total) and semaglutide concentration (Cavg) based on population pharmacokinetic analyses | Measured in nanomoles per litre (nmol/L). | From baseline to week 28 |
| Change in HbA1c |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Clinical Research | Little Rock | Arkansas | 72205 | United States | ||
| Paradigm Clinical Research |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Placebo CagriSema | Drug | Placebo matched to Cagrilintide and Placebo matched to Semaglutide will be administered subcutaneously using device 1 or device 2. |
|
Measured as %-points.
| From baseline to week 28 |
| Number of Treatment Emergent Adverse Events (TEAEs) | Measured as count of events. | From baseline to week 35 |
| Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 millimoles per litre [mmol/L]), confirmed by blood glucose (BG) meter, or severe hypoglycaemic episodes (level 3) | Measured as count of episodes. | From baseline to week 35 |
| San Diego |
| California |
| 92108 |
| United States |
| Encompass Clinical Research_Spring Valley | Spring Valley | California | 91978 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Future Medical Research | Longwood | Florida | 32750 | United States |
| New Horizon Research Center | Miami | Florida | 33165 | United States |
| Clinical Site Partners Kendall Flourish Research | Miami | Florida | 33186 | United States |
| West Orange Endocrinology | Ocoee | Florida | 34761 | United States |
| Center for Diab,Obes & Metab | Pembroke Pines | Florida | 33024 | United States |
| American Research Centers of Florida | Pembroke Pines | Florida | 33027 | United States |
| Hope Clin Res & Wellness | Conyers | Georgia | 30094 | United States |
| Elevate Clinical Research | Gurnee | Illinois | 60031 | United States |
| Accellacare of Duly Oak Lawn | Oak Lawn | Illinois | 60453 | United States |
| KDCILM, LLC & Accellacare US, Inc. | Wilmington | North Carolina | 28401 | United States |
| Advanced Medical Research - Maumee | Maumee | Ohio | 43537 | United States |
| Clinical Res Collaborative | Cumberland | Rhode Island | 02864 | United States |
| Clinical Research Associates | Nashville | Tennessee | 37203 | United States |
| The Endocrine Center | Houston | Texas | 77079 | United States |
| Radiance Clinical Research | Lampasas | Texas | 76550 | United States |
| Quality Research Inc | San Antonio | Texas | 78209 | United States |
| Medrasa Clinical Research | Sherman | Texas | 75092 | United States |
| Sanos Clinic - Vejle | Vejle | Region Syddanmark | 7100 | Denmark |
| Sanos Clinic - Gandrup | Gandrup | 9362 | Denmark |
| Sanos Clinic - Herlev | Herlev | 2730 | Denmark |
| Regionshospitalet Viborg - Karkirurgisk Afsnit | Viborg | 8800 | Denmark |
| Athens Medical Center S.A. (Iatriko Psychicou) - Department of Internal Medicine & Metabolic Diseases | Athens | 11525 | Greece |
| General Hospital Of Thessaloniki Papageorgiou - 3rd Department of Internal Medicine | Efkarpia | 564 29 | Greece |
| General University Hospital Of Patras - Endocrinology Department | Pátrai | 265 04 | Greece |
| Ippokratio General Hospital Of Thessaloniki - 2nd Propaedeutic Department of Internal Medicine | Thessaloniki | 546 42 | Greece |
| Geniko Nosokomeio Thessalonikis George Papanikolaou - Internal Medicine and Diabetes Department | Thessaloniki | 570 10 | Greece |
| Thermi Clinic S.A. - Diabetes and Internal Medicine Department | Thessaloniki | 57001 | Greece |
| Hospital Tengku Ampuan Afzan | Kuantan | Pahang | 25100 | Malaysia |
| Hospital Miri | Miri | Sarawak | 98000 | Malaysia |
| Hospital Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
| Hospital Melaka | Malacca | 75400 | Malaysia |
| Hospital Seberang Jaya | Pulau Pinang | 13700 | Malaysia |
| CHC Zvezdara, Clinical department for endocrinology | Belgrade | 11000 | Serbia |
| Endocrinology, Diabetes and Metabolism Diseases Clinic | Belgrade | 11000 | Serbia |
| Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department | Kragujevac | 34000 | Serbia |
| University Clinical Centre Nis | Niš | 18 000 | Serbia |
| Diakom, spol. s r.o. | Poprad | 05801 | Slovakia |
| MED-DIA CENTRUM s.r.o. | Považská Bystrica | 01701 | Slovakia |
| DIALIPID, s.r.o. | Prešov | 080 01 | Slovakia |
| iDia s. r. o. | Žiar nad Hronom | 965 01 | Slovakia |
| MEDIVASA, s.r.o., Diabetologicka ambulancia | Žilina | 010 01 | Slovakia |
| Centro Periferico De Especialidades Bola Azul | Almería | 04009 | Spain |
| EBA Vallcarca SLP | Barcelona | 08023 | Spain |
| CAPSBE_CAP Ernest LLuch | Barcelona | 08028 | Spain |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Centro de Salud Cabra Matrona Antonia Mesa | Cabra | 14940 | Spain |
| CAP Alhambra | L'Hospitalet de Llobregat | 08920 | Spain |
| Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada | Manresa | 08243 | Spain |
| Centro de Salud Monzón Urbano | Monzón | 22400 | Spain |
| Centro de Salud Pola de Siero | Pola de Siero | 33510 | Spain |
| Centro de Salud San Juan de la Cruz | Pozuelo de Alarcón | 28223 | Spain |
| Clínica Nuevas Tecnologías en Diabetes y Endocrinología | Seville | 41003 | Spain |
| Phramongkutklao Hospital | Bangkok | 10400 | Thailand |
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| RIHES-CMU_Research Institute for Health Sciences | Chiang Mai | 50200 | Thailand |
| Thammasat Hospital_CRC | Pathum Thani | 12120 | Thailand |
| Songklanagarind Hospital | Songkhla | 90110 | Thailand |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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