Clinical trial NCT06542874: A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes
Official title: Safety and Efficacy of Once-weekly Subcutaneous and Once-daily Oral NNC0487-0111 in Participants With Type 2 Diabetes - a Dose Finding Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Type 2 Diabetes (T2D)
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-08-07
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria 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.
* 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.

Primary outcomes:
measure: Change in HbA1c
timeFrame: From baseline (week 0) to end of treatment (week 36)
Secondary outcomes:
measure: Relative change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in fasting plasma glucose (FPG)
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL)
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in body mass index (BMI)
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in waist circumference
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in systolic blood pressure (SBP)
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in average 24-hour systolic blood pressure (SBP)
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in high sensitivity C-Reactive Protein (hsCRP)
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in total cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in high-density lipoprotein (HDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in low-density lipoprotein (LDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in triglycerides
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Number of adverse events
timeFrame: From baseline (week 0) to end of study (week 40)
measure: Change in Urinary Albumin/Creatinine Ratio (UACR)
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Participant without macroalbuminuria (UACR < 300 mg/g) at baseline (week 0) developing (yes/no) new onset of macroalbuminuria (UACR ≥ 300 mg/g)
timeFrame: At end of treatment (week 36)
measure: Change in eGFR creatinine- and cystatin C based CKD-EPI
timeFrame: From baseline (week 0) to end of treatment (week 36)
Other outcomes:
Locations:
city: Santa Ana
country: United States
facility: Southern Cal Clinical Research
state: California
city: Waterbury
country: United States
facility: Chase Medical Research LLC
state: Connecticut
city: Waterbury
country: United States
facility: Chase Medical Research LLC
state: Connecticut
city: Fleming Island
country: United States
facility: Fleming Island Ctr for Clin Res
state: Florida
city: Fleming Island
country: United States
facility: Fleming Island Ctr for Clin Res
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research LLC
state: Florida
city: Miramar
country: United States
facility: South Broward Research LLC
state: Florida
city: Miramar
country: United States
facility: South Broward Research LLC
state: Florida
city: Orlando
country: United States
facility: Florida Inst For Clin Res
state: Florida
city: Orlando
country: United States
facility: Florida Inst For Clin Res
state: Florida
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Paducah
country: United States
facility: Advanced Internal Medicine, PLLC
state: Kentucky
city: Paducah
country: United States
facility: Advanced Internal Medicine, PLLC
state: Kentucky
city: Hyattsville
country: United States
facility: Medstar Research Institute_Hyattsville
state: Maryland
city: Hyattsville
country: United States
facility: Medstar Research Institute_Hyattsville
state: Maryland
city: Oxon Hill
country: United States
facility: MD Medical Research
state: Maryland
city: Oxon Hill
country: United States
facility: MD Medical Research
state: Maryland
city: Troy
country: United States
facility: Arcturus HC PLC Troy Med Res
state: Michigan
city: Troy
country: United States
facility: Arcturus Healthcare, PLC
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Albany
country: United States
facility: Albany Medical College - Endo
state: New York
city: Morehead City
country: United States
facility: Lucas Research Inc.
state: North Carolina
city: Statesville
country: United States
facility: Piedmont Healthcare/Research
state: North Carolina
city: Statesville
country: United States
facility: Piedmont Healthcare/Research
state: North Carolina
city: Fargo
country: United States
facility: Plains Clinical Research Center, LLC_Fargo
state: North Dakota
city: Fargo
country: United States
facility: Plains Clinical Research Center, LLC_Fargo
state: North Dakota
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians_Pittsburgh
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians_Pittsburgh
state: Pennsylvania
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Nashville
country: United States
facility: Clinical Research Associates
state: Tennessee
city: Nashville
country: United States
facility: MidState Endocrine Associates
state: Tennessee
city: Nashville
country: United States
facility: MidState Endocrine Associates
state: Tennessee
city: Dallas
country: United States
facility: Velocity Clinical Res-Dallas
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Res-Dallas
state: Texas
city: Houston
country: United States
facility: Victorium Clinical Research
state: Texas
city: Houston
country: United States
facility: Synergy Groups Medical
state: Texas
city: Houston
country: United States
facility: Synergy Groups Medical
state: Texas
city: Houston
country: United States
facility: PlanIt Research, PLLC
state: Texas
city: Houston
country: United States
facility: PlanIt Research, PLLC
state: Texas
city: Lampasas
country: United States
facility: Radiance Clinical Research
state: Texas
city: McKinney
country: United States
facility: Tekton Research
state: Texas
city: McKinney
country: United States
facility: Tekton Research
state: Texas
city: Waco
country: United States
facility: Hillcrest Family Health Center
state: Texas
city: Waco
country: United States
facility: Hillcrest Family Health Center
state: Texas
city: Kyustendil
country: Bulgaria
facility: Individual Practice For Specialized Outpatient Medical Care Doctor Miglena Rizova Ltd.
city: Kyustendil
country: Bulgaria
facility: Individual Practice For Specialized Outpatient Medical Care Doctor Miglena Rizova Ltd.
city: Plovdiv
country: Bulgaria
facility: UMHAT "Kaspela", Depart. Endocrinology and Metab. Diseases
city: Plovdiv
country: Bulgaria
facility: UMHAT "Kaspela", Depart. Endocrinology and Metab. Diseases
city: Plovdiv
country: Bulgaria
facility: Diagnostic-Consultative Centre "Sveti Georgi" Eood
city: Plovdiv
country: Bulgaria
facility: Diagnostic-Consultative Centre "Sveti Georgi" Eood
city: Sofia
country: Bulgaria
facility: Medical centre Regina Life Clinic EOOD
city: Sofia
country: Bulgaria
facility: Medical centre Regina Life Clinic EOOD
city: Sofia
country: Bulgaria
facility: UMHAT "Aleksandrovska"
city: Sofia
country: Bulgaria
facility: UMHAT "Aleksandrovska"
city: Sofia
country: Bulgaria
facility: USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology
city: Sofia
country: Bulgaria
facility: USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology
city: Varna
country: Bulgaria
facility: AIPSMC Dr. Artin Magardichyan EOOD
city: Varna
country: Bulgaria
facility: AIPSMC Dr. Artin Magardichyan EOOD
city: Zagreb
country: Croatia
facility: Poliklinika Solmed
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Poliklinika Solmed
state: Grad Zagreb
city: Rijeka
country: Croatia
facility: KBC Rijeka, Endokrinologija
state: Primorsko - Goranska Županija
city: Rijeka
country: Croatia
facility: KBC Rijeka, Endokrinologija
state: Primorsko - Goranska Županija
city: Karlovac
country: Croatia
facility: Opca bolnica Karlovac
city: Karlovac
country: Croatia
facility: Opca bolnica Karlovac
city: Krapinske Toplice
country: Croatia
facility: Specijalna bolnica Krapinske Toplice - Endokrinologija
city: Krapinske Toplice
country: Croatia
facility: Specijalna Bolnica Za Medicinsku Rehabilitaciju Krapinske Toplice
city: Osijek
country: Croatia
facility: Klinicki bolnicki centar Osijek
city: Osijek
country: Croatia
facility: Klinicki bolnicki centar Osijek
city: Varazdin
country: Croatia
facility: Opca bolnica Varazdin
city: Varazdin
country: Croatia
facility: Opca bolnica Varazdin
city: Elsterwerda
country: Germany
facility: Zentrum fuer klinische Studien Suedbrandenburg GmbH
city: Elsterwerda
country: Germany
facility: Zentrum fuer klinische Studien Suedbrandenburg GmbH
city: Essen
country: Germany
facility: InnoDiab Forschung GmbH
city: Essen
country: Germany
facility: InnoDiab Forschung GmbH
city: Hamburg
country: Germany
facility: Wendisch/Dahl Hamburg (DZHW)
city: Hamburg
country: Germany
facility: Wendisch/Dahl Hamburg
city: Münster
country: Germany
facility: Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
city: Münster
country: Germany
facility: Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
city: Oldenburg in Holstein
country: Germany
facility: RED-Institut für medizinische Forschung und Fortbildung GmbH
city: Oldenburg in Holstein
country: Germany
facility: RED-Institut für medizinische Forschung und Fortbildung GmbH
city: Athens
country: Greece
facility: Iatriko Psychicou Private Clinic
city: Athens
country: Greece
facility: Iatriko Psychicou Private Clinic
city: Athens
country: Greece
facility: U.G.H of Athens "Attikon"
city: Athens
country: Greece
facility: U.G.H of Athens "Attikon"
city: Goudi/Athens
country: Greece
facility: "Laiko" General Hospital of Athens
city: Goudi/Athens
country: Greece
facility: "Laiko" General Hospital of Athens
city: Thessaloniki
country: Greece
facility: EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
city: Thessaloniki
country: Greece
facility: 424 Military General Training Hospital
city: Thessaloniki
country: Greece
facility: 424 Military General Training Hospital
city: Thessaloniki
country: Greece
facility: "Thermi" Private Hosital
city: Thessaloniki
country: Greece
facility: EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
city: Thessaloniki
country: Greece
facility: "Thermi" Private Hosital
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Kórház
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Kórház
city: Budapest
country: Hungary
facility: MH Egészségügyi Központ
city: Budapest
country: Hungary
facility: MH Egészségügyi Központ
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Gyula
country: Hungary
facility: Békés Megyei Központi Kórház
city: Gyula
country: Hungary
facility: Békés Megyei Központi Kórház
city: Kaposvár
country: Hungary
facility: Somogy Vármegyei Kaposi Mór Oktató Kórház
city: Kaposvár
country: Hungary
facility: Somogy Vármegyei Kaposi Mór Oktató Kórház
city: Miyazaki-shi
country: Japan
facility: Heiwadai Hospital
state: Miyazaki
city: Miyazaki-shi
country: Japan
facility: Heiwadai Hospital
state: Miyazaki
city: Aichi
country: Japan
facility: TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
city: Aichi
country: Japan
facility: TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
city: Chiba-shi, Chiba
country: Japan
facility: Akaicho Clinic
city: Chiba-shi, Chiba
country: Japan
facility: Akaicho Clinic
city: Chiba
country: Japan
facility: Tokuyama clinic
city: Chiba
country: Japan
facility: Tokuyama clinic
city: Ibaraki
country: Japan
facility: Naka Kinen Clinic
city: Ibaraki
country: Japan
facility: Naka Kinen Clinic
city: Tokyo
country: Japan
facility: Tokyo-Eki Center-building Clinic
city: Tokyo
country: Japan
facility: Tokyo-Eki Center-building Clinic
city: Tokyo
country: Japan
facility: Fukuwa Clinic
city: Tokyo
country: Japan
facility: Fukuwa Clinic
city: Legnica
country: Poland
facility: Beata Mikłaszewicz & Dariusz Dąbrowski "CARDIAMED" s.j.
state: Dolnośląskie
city: Legnica
country: Poland
facility: Beata Mikłaszewicz & Dariusz Dąbrowski "CARDIAMED" s.j.
state: Dolnośląskie
city: Lublin
country: Poland
facility: EKAMED sp. z o.o.
state: Lubelskie
city: Krakow
country: Poland
facility: Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
state: Malopolskie
city: Krakow
country: Poland
facility: Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
state: Malopolskie
city: Oswiecim
country: Poland
facility: Formed 2 Sp. z o.o.
state: Malopolskie
city: Oswiecim
country: Poland
facility: Formed 2 Sp. z o.o.
state: Malopolskie
city: Siedlce
country: Poland
facility: ETG Siedlce
state: Masovian
city: Siedlce
country: Poland
facility: ETG Siedlce
state: Masovian
city: Bialystok
country: Poland
facility: NZOZ Vita-Diabetica Malgorzata Buraczyk
state: Podlaskie Voivodeship
city: Bialystok
country: Poland
facility: NZOZ Vita-Diabetica Malgorzata Buraczyk
state: Podlaskie Voivodeship
city: Bialystok
country: Poland
facility: Specderm Poznańska Spółka Jawna
state: Podlaskie
city: Lodz
country: Poland
facility: Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia
state: Wojewodztwo Lodzkie
city: Lodz
country: Poland
facility: Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia
state: Wojewodztwo Lodzkie
city: Bialystok
country: Poland
facility: Specderm Poznańska Spółka Jawna
city: Lublin
country: Poland
facility: EKAMED sp. z o.o.
city: Ruda Slaska
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.
city: Ruda Slaska
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.
city: Warszawa
country: Poland
facility: PANSTWOWY INSTYTUT MEDYCZNY MSWiA
city: Warszawa
country: Poland
facility: PANSTWOWY INSTYTUT MEDYCZNY MSWiA
city: Oradea
country: Romania
facility: SC Grand Med SRL
state: Bihor
city: Oradea
country: Romania
facility: SC Grand Med SRL
state: Bihor
city: Bucharest
country: Romania
facility: Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
state: Bucurestii
city: Bucharest
country: Romania
facility: Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
state: Bucurestii
city: Cluj Napoca
country: Romania
facility: Spitalul Clinic Judetean Urgenta Cluj-Napoca
state: Cluj
city: Cluj Napoca
country: Romania
facility: Spitalul Clinic Judetean Urgenta Cluj-Napoca
state: Cluj
city: Tirgu Mures
country: Romania
facility: Sc Mediab Srl
state: Mures
city: Tirgu Mures
country: Romania
facility: Sc Mediab Srl
state: Mures
city: Ploiesti
country: Romania
facility: Novus Medical Clinica SRL
state: Prahova
city: Ploiesti
country: Romania
facility: Novus Medical Clinica SRL
state: Prahova
city: Brasov
country: Romania
facility: Mariodiab Clinic SRL
city: Brasov
country: Romania
facility: Mariodiab Clinic SRL
city: Timisoara
country: Romania
facility: Cabinet Medical Dr Geru SRL
city: Timisoara
country: Romania
facility: Cabinet Medical Dr Geru SRL
city: Timisoara
country: Romania
facility: Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
city: Timisoara
country: Romania
facility: Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
city: Sahy
country: Slovakia
facility: Peter Farkas MD, s.r.o.
state: Slovak Republic
city: Sahy
country: Slovakia
facility: Peter Farkas MD, s.r.o.
state: Slovak Republic
city: Poprad
country: Slovakia
facility: DENTAVIA s.r.o.
city: Poprad
country: Slovakia
facility: DENTAVIA s.r.o.
city: Presov
country: Slovakia
facility: DIABETOL, s.r.o.
city: Presov
country: Slovakia
facility: DIABETOL, s.r.o.
city: Rimavska Sobota
country: Slovakia
facility: OLIVER - MED s.r.o.
city: Rimavska Sobota
country: Slovakia
facility: OLIVER - MED s.r.o.
city: Zilina
country: Slovakia
facility: MEDIVASA, s.r.o., Diabetologicka ambulancia
city: Zilina
country: Slovakia
facility: MEDIVASA, s.r.o., Diabetologicka ambulancia
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Castilleja Dela Cuesta Sevilla
country: Spain
facility: Hospital Vithas Sevilla
city: La Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: La Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Clínica Nuevas Tecnologías en Diabetes y Endocrinología
city: Sevilla
country: Spain
facility: Clínica Nuevas Tecnologías en Diabetes y Endocrinología
city: Sevilla
country: Spain
facility: Hospital Infanta Luisa
city: Sevilla
country: Spain
facility: Hospital Infanta Luisa
city: Sevilla
country: Spain
facility: Hospital Nisa Sevilla Aljarafe
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: