A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes
NCT ID: NCT06542874
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
448 participants
INTERVENTIONAL
2024-08-07
2025-10-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NNC0487-0111 subcutaneous dose 4
NNC0487-0111 subcutaneous dose 4 treatment
NNC0487-0111 subcutanous
NNC0487-0111 administered subcutanously (under the skin)
NNC0487-0111 subcutaneous dose 5
NNC0487-0111 subcutaneous dose 5 treatment
NNC0487-0111 subcutanous
NNC0487-0111 administered subcutanously (under the skin)
NNC0487-0111 subcutaneous dose 6
NNC0487-0111 subcutaneous dose 6 treatment
NNC0487-0111 subcutanous
NNC0487-0111 administered subcutanously (under the skin)
Placebo oral
Placebo for oral treatment
Placebo (NNC0487-0111 oral)
NNC0487-0111 placebo administered orally (in the mouth)
NNC0487-0111 oral dose 1
NNC0487-0111 oral dose 1 treatment
NNC0487-0111 oral
NNC0487-0111 administered orally (in the mouth)
NNC0487-0111 oral dose 2
NNC0487-0111 oral dose 2 treatment
NNC0487-0111 oral
NNC0487-0111 administered orally (in the mouth)
NNC0487-0111 oral dose 3
NNC0487-0111 oral dose 3 treatment
NNC0487-0111 oral
NNC0487-0111 administered orally (in the mouth)
Placebo subcutaneous
Placebo for subcutaneous treatment
Placebo (NNC0487-0111 subcutanous)
NNC0487-0111 placebo administered subcutanously (under the skin)
NNC0487-0111 subcutaneous dose 1
NNC0487-0111 subcutaneous dose 1 treatment
NNC0487-0111 subcutanous
NNC0487-0111 administered subcutanously (under the skin)
NNC0487-0111 subcutaneous dose 2
NNC0487-0111 subcutaneous dose 2 treatment
NNC0487-0111 subcutanous
NNC0487-0111 administered subcutanously (under the skin)
NNC0487-0111 subcutaneous dose 3
NNC0487-0111 subcutaneous dose 3 treatment
NNC0487-0111 subcutanous
NNC0487-0111 administered subcutanously (under the skin)
Interventions
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NNC0487-0111 subcutanous
NNC0487-0111 administered subcutanously (under the skin)
Placebo (NNC0487-0111 subcutanous)
NNC0487-0111 placebo administered subcutanously (under the skin)
NNC0487-0111 oral
NNC0487-0111 administered orally (in the mouth)
Placebo (NNC0487-0111 oral)
NNC0487-0111 placebo administered orally (in the mouth)
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
* Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question.
18 Years
75 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Southern Cal Clinical Research
Santa Ana, California, United States
Chase Medical Research LLC
Waterbury, Connecticut, United States
Fleming Island Ctr for Clin Res
Fleming Island, Florida, United States
Encore Medical Research LLC
Hollywood, Florida, United States
South Broward Research LLC
Miramar, Florida, United States
Florida Inst For Clin Res
Orlando, Florida, United States
Cedar-Crosse Research Center
Chicago, Illinois, United States
Advanced Internal Medicine, PLLC
Paducah, Kentucky, United States
Medstar Research Institute_Hyattsville
Hyattsville, Maryland, United States
MD Medical Research
Oxon Hill, Maryland, United States
Arcturus HC PLC Troy Med Res
Troy, Michigan, United States
Arcturus Healthcare, PLC
Troy, Michigan, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
AMC Community Endocrinology
Albany, New York, United States
Lucas Research Inc.
Morehead City, North Carolina, United States
Piedmont Healthcare/Research
Statesville, North Carolina, United States
Plains Clinical Research Center, LLC_Fargo
Fargo, North Dakota, United States
Preferred Primary Care Physicians_Pittsburgh
Pittsburgh, Pennsylvania, United States
Health Concepts
Rapid City, South Dakota, United States
Clinical Research Associates
Nashville, Tennessee, United States
MidState Endocrine Associates
Nashville, Tennessee, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
Victorium Clinical Research
Houston, Texas, United States
Synergy Groups Medical
Houston, Texas, United States
PlanIt Research, PLLC
Houston, Texas, United States
Radiance Clinical Research
Lampasas, Texas, United States
Tekton Research
McKinney, Texas, United States
Hillcrest Family Health Center
Waco, Texas, United States
Individual Practice For Specialized Outpatient Medical Care Doctor Miglena Rizova Ltd.
Kyustendil, , Bulgaria
IPSOMC Dr. Miglena Rizova Ltd.
Kyustendil, , Bulgaria
UMHAT "Kaspela", Depart. Endocrinology and Metab. Diseases
Plovdiv, , Bulgaria
UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic
Plovdiv, , Bulgaria
DCC Sveti Georgi EOOD
Plovdiv, , Bulgaria
Diagnostic-Consultative Centre "Sveti Georgi" Eood
Plovdiv, , Bulgaria
Medical centre Regina Life Clinic EOOD
Sofia, , Bulgaria
UMHAT "Aleksandrovska"
Sofia, , Bulgaria
USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology
Sofia, , Bulgaria
USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology
Sofia, , Bulgaria
AIPSMC Dr. Artin Magardichyan EOOD
Varna, , Bulgaria
Poliklinika Solmed
Zagreb, City of Zagreb, Croatia
Clinical Hospital Centre Rijeka_Endocrinology
Rijeka, Primorje-Gorski Kotar County, Croatia
KBC Rijeka, Endokrinologija
Rijeka, Primorje-Gorski Kotar County, Croatia
Opca bolnica Karlovac
Karlovac, , Croatia
Specijalna bolnica Krapinske Toplice - Endokrinologija
Krapinske Toplice, , Croatia
Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology
Krapinske Toplice, , Croatia
Klinicki bolnicki centar Osijek_Endocrinology
Osijek, , Croatia
Klinicki bolnicki centar Osijek
Osijek, , Croatia
Opca bolnica Varazdin_Endocrinology
Varaždin, , Croatia
Opca bolnica Varazdin
Varaždin, , Croatia
Zentrum fuer klinische Studien Suedbrandenburg GmbH
Elsterwerda, , Germany
InnoDiab Forschung GmbH
Essen, , Germany
Wendisch/Dahl Hamburg (DZHW)
Hamburg, , Germany
Wendisch/Dahl Hamburg
Hamburg, , Germany
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
Münster, , Germany
RED-Institut für medizinische Forschung und Fortbildung GmbH
Oldenburg in Holstein, , Germany
Iatriko Psychicou Private Clinic
Athens, , Greece
U.G.H of Athens "Attikon"
Athens, , Greece
"Laiko" General Hospital of Athens
Goudi/Athens, , Greece
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
Thessaloniki, , Greece
424 Military General Training Hospital - 2nd Department of Internal Medicine
Thessaloniki, , Greece
424 Military General Training Hospital
Thessaloniki, , Greece
"Thermi" Private Hosital
Thessaloniki, , Greece
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
Thessaloniki, , Greece
"Thermi" Private Hosital
Thessaloniki, , Greece
Debreceni Egyetem
Debrecen, Hajdú-Bihar, Hungary
Bajcsy-Zsilinszky Kórház
Budapest, , Hungary
MH Egészségügyi Központ
Budapest, , Hungary
Debreceni Egyetem
Debrecen, , Hungary
Debreceni Egyetem
Debrecen, , Hungary
Debreceni Egyetem
Debrecen, , Hungary
Békés Megyei Központi Kórház
Gyula, , Hungary
Somogy Vármegyei Kaposi Mór Oktató Kórház
Kaposvár, , Hungary
Somogy Vármegyei Kaposi Mór Oktató Kórház
Kaposvár, , Hungary
Heiwadai Hospital_Internal Medicine
Miyazaki, Miyazaki, Japan
Heiwadai Hospital
Miyazaki, Miyazaki, Japan
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
Aichi, , Japan
Tokuyama clinic_Diabetic internal medicine
Chiba, , Japan
Tokuyama clinic
Chiba, , Japan
Akaicho Clinic
Chiba-shi, Chiba, , Japan
Naka Kinen Clinic_Internal medicine
Ibaraki, , Japan
Naka Kinen Clinic
Ibaraki, , Japan
Tokyo-Eki Center-building Clinic_Internal Medicine
Tokyo, , Japan
Tokyo-Eki Center-building Clinic
Tokyo, , Japan
Fukuwa Clinic_Internal Medicine
Tokyo, , Japan
Fukuwa Clinic
Tokyo, , Japan
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
Krakow, Lesser Poland Voivodeship, Poland
Formed 2 Sp. z o.o.
Oświęcim, Lesser Poland Voivodeship, Poland
Beata Miklaszewicz & Dariusz Dabrowski "CARDIAMED" s.j.
Legnica, Lower Silesian Voivodeship, Poland
Beata Mikłaszewicz & Dariusz Dąbrowski "CARDIAMED" s.j.
Legnica, Lower Silesian Voivodeship, Poland
EKAMED sp. z o.o.
Lublin, Lublin Voivodeship, Poland
ETG Siedlce
Siedlce, Masovian Voivodeship, Poland
Specderm Poznanska Sp. j.
Bialystok, Podlaskie Voivodeship, Poland
NZOZ Vita-Diabetica Malgorzata Buraczyk
Bialystok, Podlaskie Voivodeship, Poland
Specderm Poznańska Spółka Jawna
Bialystok, , Poland
EKAMED sp. z o.o.
Lublin, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.
Ruda Śląska, , Poland
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
Warsaw, , Poland
Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia
Lodz, Łódź Voivodeship, Poland
SC Grand Med SRL
Oradea, Bihor County, Romania
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
Bucharest, Bucurestii, Romania
Spitalul Clinic Judetean Urgenta Cluj-Napoca
Cluj-Napoca, Cluj, Romania
Sc Mediab Srl
Târgu Mureş, Mureș County, Romania
Novus Medical Clinica SRL
Ploieşti, Prahova, Romania
Mariodiab Clinic SRL
Brasov, , Romania
Cabinet Medical Dr Geru SRL
Timișoara, , Romania
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Timișoara, , Romania
Peter Farkas MD, s.r.o.
Šahy, Slovak Republic, Slovakia
DENTAVIA s.r.o.
Poprad, , Slovakia
DIABETOL, s.r.o.
Prešov, , Slovakia
OLIVER - MED s.r.o.
Rimavská Sobota, , Slovakia
MEDIVASA, s.r.o., Diabetologicka ambulancia
Žilina, , Slovakia
Complejo Hospitalario Universitario A Coruña
A Coruña, , Spain
Hospital Clinic i Provincial
Barcelona, , Spain
Hospital Gregorio Marañón
Madrid, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
Seville, , Spain
Hospital Infanta Luisa
Seville, , Spain
Hospital Nisa Sevilla Aljarafe
Seville, , Spain
Hospital Vithas Sevilla
Seville, , Spain
Countries
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Other Identifiers
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U1111-1296-9708
Identifier Type: OTHER
Identifier Source: secondary_id
2023-509412-28
Identifier Type: OTHER
Identifier Source: secondary_id
NN9490-7678
Identifier Type: -
Identifier Source: org_study_id