Safety and Efficacy of Once-weekly Subcutaneous and Once-daily Oral NNC0487-0111 in Participants With Type 2 Diabetes - a Dose Finding Study
Status: Recruiting
Location: See all (179) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The study will look at how well different doses of a new medicine called NNC0487-0111 help lower the blood sugar and body weight in people with type 2 diabetes. NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Participants will either get NNC0487-0111, which is given as tablets or as injections, or placebo. Which treatment the participant get is decided by chance.The study will last for about 43 weeks.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Male or female, aged 18-75 years (both inclusive) at the time of signing the informed consent.
• Diagnosed with type 2 diabetes mellitus greater or equal to 180 days before screening.
• Stable daily dose(s) greater or equal to 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without SGLT2 inhibitor.
• HbA1c of 7.0-10.0 procent (53-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening.
• Body mass index between greater or equal to 23.0 and below 50.0 kg/m\^2.
• Able and willing to adhere to the protocol including wearing a continuous glucose monitoring (CGM) device provided for the study, as judged by the investigator.
Locations
United States
California
Southern Cal Clinical Research
ACTIVE_NOT_RECRUITING
Santa Ana
Connecticut
Chase Medical Research LLC
WITHDRAWN
Waterbury
Chase Medical Research LLC
NOT_YET_RECRUITING
Waterbury
Florida
Fleming Island Ctr for Clin Res
NOT_YET_RECRUITING
Fleming Island
Fleming Island Ctr for Clin Res
ACTIVE_NOT_RECRUITING
Fleming Island
Encore Medical Research LLC
ACTIVE_NOT_RECRUITING
Hollywood
South Broward Research LLC
RECRUITING
Miramar
South Broward Research LLC
COMPLETED
Miramar
Florida Inst For Clin Res
NOT_YET_RECRUITING
Orlando
Florida Inst For Clin Res
ACTIVE_NOT_RECRUITING
Orlando
Illinois
Cedar-Crosse Research Center
ACTIVE_NOT_RECRUITING
Chicago
Kentucky
Advanced Internal Medicine, PLLC
NOT_YET_RECRUITING
Paducah
Advanced Internal Medicine, PLLC
ACTIVE_NOT_RECRUITING
Paducah
Maryland
Medstar Research Institute_Hyattsville
NOT_YET_RECRUITING
Hyattsville
Medstar Research Institute_Hyattsville
WITHDRAWN
Hyattsville
MD Medical Research
NOT_YET_RECRUITING
Oxon Hill
MD Medical Research
WITHDRAWN
Oxon Hill
Michigan
Arcturus HC PLC Troy Med Res
ACTIVE_NOT_RECRUITING
Troy
Arcturus Healthcare, PLC
RECRUITING
Troy
Missouri
Clinical Research Professionals
COMPLETED
Chesterfield
Clinical Research Professionals
NOT_YET_RECRUITING
Chesterfield
North Carolina
Lucas Research Inc.
WITHDRAWN
Morehead City
Piedmont Healthcare/Research
WITHDRAWN
Statesville
Piedmont Healthcare/Research
NOT_YET_RECRUITING
Statesville
North Dakota
Plains Clinical Research Center, LLC_Fargo
ACTIVE_NOT_RECRUITING
Fargo
Plains Clinical Research Center, LLC_Fargo
NOT_YET_RECRUITING
Fargo
New York
AMC Community Endocrinology
WITHDRAWN
Albany
Pennsylvania
Preferred Primary Care Physicians_Pittsburgh
COMPLETED
Pittsburgh
Preferred Primary Care Physicians_Pittsburgh
NOT_YET_RECRUITING
Pittsburgh
South Dakota
Health Concepts
ACTIVE_NOT_RECRUITING
Rapid City
Tennessee
Clinical Research Associates
ACTIVE_NOT_RECRUITING
Nashville
MidState Endocrine Associates
COMPLETED
Nashville
MidState Endocrine Associates
NOT_YET_RECRUITING
Nashville
Texas
Velocity Clinical Res-Dallas
NOT_YET_RECRUITING
Dallas
Velocity Clinical Res-Dallas
ACTIVE_NOT_RECRUITING
Dallas
PlanIt Research, PLLC
COMPLETED
Houston
PlanIt Research, PLLC
NOT_YET_RECRUITING
Houston
Synergy Groups Medical
RECRUITING
Houston
Synergy Groups Medical
COMPLETED
Houston
Victorium Clinical Research
WITHDRAWN
Houston
Radiance Clinical Research
ACTIVE_NOT_RECRUITING
Lampasas
Tekton Research
ACTIVE_NOT_RECRUITING
Mckinney
Tekton Research
NOT_YET_RECRUITING
Mckinney
Hillcrest Family Health Center
NOT_YET_RECRUITING
Waco
Hillcrest Family Health Center
WITHDRAWN
Waco
Other Locations
Bulgaria
Individual Practice For Specialized Outpatient Medical Care Doctor Miglena Rizova Ltd.
NOT_YET_RECRUITING
Kyustendil
IPSOMC Dr. Miglena Rizova Ltd.
COMPLETED
Kyustendil
Diagnostic-Consultative Centre Sveti Georgi Eood
NOT_YET_RECRUITING
Plovdiv
Diagnostic-Consultative Centre Sveti Georgi Eood
COMPLETED
Plovdiv
UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic
COMPLETED
Plovdiv
UMHAT Kaspela, Depart. Endocrinology and Metab. Diseases
NOT_YET_RECRUITING
Plovdiv
Medical centre Regina Life Clinic EOOD
ACTIVE_NOT_RECRUITING
Sofia
Medical centre Regina Life Clinic EOOD
NOT_YET_RECRUITING
Sofia
UMHAT Aleksandrovska
NOT_YET_RECRUITING
Sofia
UMHAT Aleksandrovska
ACTIVE_NOT_RECRUITING
Sofia
USHATE Akad. Ivan Penchev Second Clinic of Endocrinology
ACTIVE_NOT_RECRUITING
Sofia
USHATE Akad. Ivan Penchev Second Clinic of Endocrinology
NOT_YET_RECRUITING
Sofia
AIPSMC Dr. Artin Magardichyan EOOD
NOT_YET_RECRUITING
Varna
AIPSMC Dr. Artin Magardichyan EOOD
ACTIVE_NOT_RECRUITING
Varna
Croatia
Opca bolnica Karlovac
NOT_YET_RECRUITING
Karlovac
Opca bolnica Karlovac
COMPLETED
Karlovac
Specijalna bolnica Krapinske Toplice - Endokrinologija
NOT_YET_RECRUITING
Krapinske Toplice
Specijalna Bolnica Za Medicinsku Rehabilitaciju Krapinske Toplice
COMPLETED
Krapinske Toplice
Klinicki bolnicki centar Osijek
ACTIVE_NOT_RECRUITING
Osijek
Klinicki bolnicki centar Osijek
NOT_YET_RECRUITING
Osijek
KBC Rijeka, Endokrinologija
NOT_YET_RECRUITING
Rijeka
KBC Rijeka, Endokrinologija
COMPLETED
Rijeka
Opca bolnica Varazdin
NOT_YET_RECRUITING
Varaždin
Opca bolnica Varazdin_Endocrinology
COMPLETED
Varaždin
Poliklinika Solmed
NOT_YET_RECRUITING
Zagreb
Poliklinika Solmed
ACTIVE_NOT_RECRUITING
Zagreb
Germany
Zentrum fuer klinische Studien Suedbrandenburg GmbH
WITHDRAWN
Elsterwerda
Zentrum fuer klinische Studien Suedbrandenburg GmbH
NOT_YET_RECRUITING
Elsterwerda
InnoDiab Forschung GmbH
ACTIVE_NOT_RECRUITING
Essen
InnoDiab Forschung GmbH
NOT_YET_RECRUITING
Essen
Wendisch/Dahl Hamburg
NOT_YET_RECRUITING
Hamburg
Wendisch/Dahl Hamburg (DZHW)
COMPLETED
Hamburg
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
ACTIVE_NOT_RECRUITING
Münster
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
NOT_YET_RECRUITING
Münster
RED-Institut für medizinische Forschung und Fortbildung GmbH
COMPLETED
Oldenburg In Holstein
RED-Institut für medizinische Forschung und Fortbildung GmbH
NOT_YET_RECRUITING
Oldenburg In Holstein
Greece
Iatriko Psychicou Private Clinic
NOT_YET_RECRUITING
Athens
Iatriko Psychicou Private Clinic
ACTIVE_NOT_RECRUITING
Athens
U.G.H of Athens Attikon
ACTIVE_NOT_RECRUITING
Athens
U.G.H of Athens Attikon
NOT_YET_RECRUITING
Athens
Laiko General Hospital of Athens
NOT_YET_RECRUITING
Goudi/athens
Laiko General Hospital of Athens
ACTIVE_NOT_RECRUITING
Goudi/athens
424 Military General Training Hospital
NOT_YET_RECRUITING
Thessaloniki
424 Military General Training Hospital
ACTIVE_NOT_RECRUITING
Thessaloniki
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
ACTIVE_NOT_RECRUITING
Thessaloniki
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
NOT_YET_RECRUITING
Thessaloniki
Thermi Private Hosital
ACTIVE_NOT_RECRUITING
Thessaloniki
Thermi Private Hosital
NOT_YET_RECRUITING
Thessaloniki
Hungary
Bajcsy-Zsilinszky Kórház
NOT_YET_RECRUITING
Budapest
Bajcsy-Zsilinszky Kórház
COMPLETED
Budapest
MH Egészségügyi Központ
COMPLETED
Budapest
MH Egészségügyi Központ
NOT_YET_RECRUITING
Budapest
Debreceni Egyetem
COMPLETED
Debrecen
Debreceni Egyetem
NOT_YET_RECRUITING
Debrecen
Debreceni Egyetem
COMPLETED
Debrecen
Debreceni Egyetem
NOT_YET_RECRUITING
Debrecen
Békés Megyei Központi Kórház
NOT_YET_RECRUITING
Gyula
Békés Megyei Központi Kórház
WITHDRAWN
Gyula
Somogy Vármegyei Kaposi Mór Oktató Kórház
COMPLETED
Kaposvár
Somogy Vármegyei Kaposi Mór Oktató Kórház
NOT_YET_RECRUITING
Kaposvár
Japan
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
NOT_YET_RECRUITING
Aichi
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
COMPLETED
Aichi
Tokuyama clinic
NOT_YET_RECRUITING
Chiba
Tokuyama clinic_Diabetic internal medicine
COMPLETED
Chiba
Akaicho Clinic
NOT_YET_RECRUITING
Chiba-shi, Chiba
Akaicho Clinic
ACTIVE_NOT_RECRUITING
Chiba-shi, Chiba
Naka Kinen Clinic
RECRUITING
Ibaraki
Naka Kinen Clinic_Internal medicine
ACTIVE_NOT_RECRUITING
Ibaraki
Heiwadai Hospital
NOT_YET_RECRUITING
Miyazaki
Heiwadai Hospital_Internal Medicine
COMPLETED
Miyazaki
Fukuwa Clinic
NOT_YET_RECRUITING
Tokyo
Fukuwa Clinic_Internal Medicine
ACTIVE_NOT_RECRUITING
Tokyo
Tokyo-Eki Center-building Clinic
NOT_YET_RECRUITING
Tokyo
Tokyo-Eki Center-building Clinic_Internal Medicine
ACTIVE_NOT_RECRUITING
Tokyo
Poland
NZOZ Vita-Diabetica Malgorzata Buraczyk
NOT_YET_RECRUITING
Bialystok
NZOZ Vita-Diabetica Malgorzata Buraczyk
COMPLETED
Bialystok
Specderm Poznanska Sp. j.
WITHDRAWN
Bialystok
Specderm Poznańska Spółka Jawna
NOT_YET_RECRUITING
Bialystok
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
NOT_YET_RECRUITING
Krakow
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
COMPLETED
Krakow
Beata Mikłaszewicz & Dariusz Dąbrowski CARDIAMED s.j.
ACTIVE_NOT_RECRUITING
Legnica
Beata Mikłaszewicz & Dariusz Dąbrowski CARDIAMED s.j.
NOT_YET_RECRUITING
Legnica
Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia
NOT_YET_RECRUITING
Lodz
Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia
COMPLETED
Lodz
EKAMED sp. z o.o.
ACTIVE_NOT_RECRUITING
Lublin
EKAMED sp. z o.o.
NOT_YET_RECRUITING
Lublin
Formed 2 Sp. z o.o.
ACTIVE_NOT_RECRUITING
Oświęcim
Formed 2 Sp. z o.o.
NOT_YET_RECRUITING
Oświęcim
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.
COMPLETED
Ruda Śląska
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.
NOT_YET_RECRUITING
Ruda Śląska
ETG Siedlce
ACTIVE_NOT_RECRUITING
Siedlce
ETG Siedlce
NOT_YET_RECRUITING
Siedlce
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
NOT_YET_RECRUITING
Warsaw
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
ACTIVE_NOT_RECRUITING
Warsaw
Romania
Mariodiab Clinic SRL
COMPLETED
Brasov
Mariodiab Clinic SRL
NOT_YET_RECRUITING
Brasov
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
ACTIVE_NOT_RECRUITING
Bucharest
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
NOT_YET_RECRUITING
Bucharest
Spitalul Clinic Judetean Urgenta Cluj-Napoca
ACTIVE_NOT_RECRUITING
Cluj-napoca
Spitalul Clinic Judetean Urgenta Cluj-Napoca
NOT_YET_RECRUITING
Cluj-napoca
SC Grand Med SRL
COMPLETED
Oradea
SC Grand Med SRL
NOT_YET_RECRUITING
Oradea
Novus Medical Clinica SRL
ACTIVE_NOT_RECRUITING
Ploieşti
Novus Medical Clinica SRL
NOT_YET_RECRUITING
Ploieşti
Sc Mediab Srl
NOT_YET_RECRUITING
Târgu Mureş
Sc Mediab Srl
ACTIVE_NOT_RECRUITING
Târgu Mureş
Cabinet Medical Dr Geru SRL
COMPLETED
Timișoara
Cabinet Medical Dr Geru SRL
NOT_YET_RECRUITING
Timișoara
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
COMPLETED
Timișoara
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
NOT_YET_RECRUITING
Timișoara
Slovakia
DENTAVIA s.r.o.
NOT_YET_RECRUITING
Poprad
DENTAVIA s.r.o.
COMPLETED
Poprad
DIABETOL, s.r.o.
NOT_YET_RECRUITING
Prešov
DIABETOL, s.r.o.
COMPLETED
Prešov
OLIVER - MED s.r.o.
NOT_YET_RECRUITING
Rimavská Sobota
OLIVER - MED s.r.o.
COMPLETED
Rimavská Sobota
Peter Farkas MD, s.r.o.
ACTIVE_NOT_RECRUITING
Šahy
Peter Farkas MD, s.r.o.
NOT_YET_RECRUITING
Šahy
MEDIVASA, s.r.o., Diabetologicka ambulancia
NOT_YET_RECRUITING
Žilina
MEDIVASA, s.r.o., Diabetologicka ambulancia
ACTIVE_NOT_RECRUITING
Žilina
Spain
Complejo Hospitalario Universitario A Coruña
COMPLETED
A Coruña
Complejo Hospitalario Universitario A Coruña
NOT_YET_RECRUITING
A Coruña
Hospital Clinic i Provincial
NOT_YET_RECRUITING
Barcelona
Hospital Clinic i Provincial
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Gregorio Marañón
NOT_YET_RECRUITING
Madrid
Hospital Gregorio Marañón
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario Marqués de Valdecilla
NOT_YET_RECRUITING
Santander
Hospital Universitario Marqués de Valdecilla
ACTIVE_NOT_RECRUITING
Santander
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
COMPLETED
Seville
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
NOT_YET_RECRUITING
Seville
Hospital Infanta Luisa
ACTIVE_NOT_RECRUITING
Seville
Hospital Infanta Luisa
NOT_YET_RECRUITING
Seville
Hospital Nisa Sevilla Aljarafe
NOT_YET_RECRUITING
Seville
Hospital Vithas Sevilla
COMPLETED
Seville
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2024-08-07
Estimated Completion Date: 2025-10-24
Participants
Target number of participants: 432
Treatments
Placebo_comparator: Placebo subcutaneous
Placebo for subcutaneous treatment
Experimental: NNC0487-0111 subcutaneous dose 1
NNC0487-0111 subcutaneous dose 1 treatment
Experimental: NNC0487-0111 subcutaneous dose 2
NNC0487-0111 subcutaneous dose 2 treatment
Experimental: NNC0487-0111 subcutaneous dose 3
NNC0487-0111 subcutaneous dose 3 treatment
Experimental: NNC0487-0111 subcutaneous dose 4
NNC0487-0111 subcutaneous dose 4 treatment
Experimental: NNC0487-0111 subcutaneous dose 5
NNC0487-0111 subcutaneous dose 5 treatment
Experimental: NNC0487-0111 subcutaneous dose 6
NNC0487-0111 subcutaneous dose 6 treatment
Placebo_comparator: Placebo oral
Placebo for oral treatment
Experimental: NNC0487-0111 oral dose 1
NNC0487-0111 oral dose 1 treatment
Experimental: NNC0487-0111 oral dose 2
NNC0487-0111 oral dose 2 treatment
Experimental: NNC0487-0111 oral dose 3
NNC0487-0111 oral dose 3 treatment
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S