A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes
- Conditions
- Type 2 Diabetes (T2D)
- Interventions
- Drug: NNC0487-0111 subcutanousDrug: Placebo (NNC0487-0111 subcutanous)Drug: NNC0487-0111 oralDrug: Placebo (NNC0487-0111 oral)
- Registration Number
- NCT06542874
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 432
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NNC0487-0111 subcutaneous dose 5 NNC0487-0111 subcutanous NNC0487-0111 subcutaneous dose 5 treatment Placebo subcutaneous Placebo (NNC0487-0111 subcutanous) Placebo for subcutaneous treatment NNC0487-0111 oral dose 2 NNC0487-0111 oral NNC0487-0111 oral dose 2 treatment NNC0487-0111 subcutaneous dose 2 NNC0487-0111 subcutanous NNC0487-0111 subcutaneous dose 2 treatment Placebo oral Placebo (NNC0487-0111 oral) Placebo for oral treatment NNC0487-0111 oral dose 3 NNC0487-0111 oral NNC0487-0111 oral dose 3 treatment NNC0487-0111 subcutaneous dose 1 NNC0487-0111 subcutanous NNC0487-0111 subcutaneous dose 1 treatment NNC0487-0111 subcutaneous dose 3 NNC0487-0111 subcutanous NNC0487-0111 subcutaneous dose 3 treatment NNC0487-0111 subcutaneous dose 4 NNC0487-0111 subcutanous NNC0487-0111 subcutaneous dose 4 treatment NNC0487-0111 subcutaneous dose 6 NNC0487-0111 subcutanous NNC0487-0111 subcutaneous dose 6 treatment NNC0487-0111 oral dose 1 NNC0487-0111 oral NNC0487-0111 oral dose 1 treatment
- Primary Outcome Measures
Name Time Method Change in HbA1c From baseline (week 0) to end of treatment (week 36) percent point
- Secondary Outcome Measures
Name Time Method Change in waist circumference From baseline (week 0) to end of treatment (week 36) cm
Change in systolic blood pressure (SBP) From baseline (week 0) to end of treatment (week 36) mmHg
Change in average 24-hour systolic blood pressure (SBP) From baseline (week 0) to end of treatment (week 36) mmHg
Change in high sensitivity C-Reactive Protein (hsCRP) From baseline (week 0) to end of treatment (week 36) Ratio to baseline
Relative change in body weight From baseline (week 0) to end of treatment (week 36) percent
Change in body weight From baseline (week 0) to end of treatment (week 36) kg
Change in fasting plasma glucose (FPG) From baseline (week 0) to end of treatment (week 36) mmol/L
CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) From baseline (week 0) to end of treatment (week 36) percent points
Change in body mass index (BMI) From baseline (week 0) to end of treatment (week 36) kg/m\^2
Change in total cholesterol From baseline (week 0) to end of treatment (week 36) Ratio to baseline
Change in high-density lipoprotein (HDL) cholesterol From baseline (week 0) to end of treatment (week 36) Ratio to baseline
Change in low-density lipoprotein (LDL) cholesterol From baseline (week 0) to end of treatment (week 36) Ratio to baseline
Change in triglycerides From baseline (week 0) to end of treatment (week 36) Ratio to baseline
Number of adverse events From baseline (week 0) to end of study (week 40) Count of events
Change in Urinary Albumin/Creatinine Ratio (UACR) From baseline (week 0) to end of treatment (week 36) Ratio to baseline
Participant without macroalbuminuria (UACR < 300 mg/g) at baseline (week 0) developing (yes/no) new onset of macroalbuminuria (UACR ≥ 300 mg/g) At end of treatment (week 36) Count of participant
Change in eGFR creatinine- and cystatin C based CKD-EPI From baseline (week 0) to end of treatment (week 36) mL/min/1.73 m\^2
Trial Locations
- Locations (94)
"Laiko" General Hospital of Athens
🇬🇷Goudi/Athens, Greece
Debreceni Egyetem
🇭🇺Debrecen, Hungary
Békés Megyei Központi Kórház
🇭🇺Gyula, Hungary
Somogy Vármegyei Kaposi Mór Oktató Kórház
🇭🇺Kaposvár, Hungary
Specderm Poznańska Spółka Jawna
🇵🇱Bialystok, Poland
DIABETOL, s.r.o.
🇸🇰Presov, Slovakia
OLIVER - MED s.r.o.
🇸🇰Rimavska Sobota, Slovakia
MEDIVASA, s.r.o., Diabetologicka ambulancia
🇸🇰Zilina, Slovakia
Hospital Clinic i Provincial
🇪🇸Barcelona, Spain
Hospital Vithas Sevilla
🇪🇸Castilleja Dela Cuesta Sevilla, Spain
Complejo Hospitalario Universitario A Coruña
🇪🇸La Coruña, Spain
Hospital Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Nisa Sevilla Aljarafe
🇪🇸Sevilla, Spain
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 Healthcare, PLC
🇺🇸Troy, Michigan, United States
Clinical Research Professionals
🇺🇸Chesterfield, Missouri, United States
Albany Medical College - Endo
🇺🇸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
UMHAT "Kaspela", Depart. Endocrinology and Metab. Diseases
🇧🇬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
AIPSMC Dr. Artin Magardichyan EOOD
🇧🇬Varna, Bulgaria
Poliklinika Solmed
🇭🇷Zagreb, Grad Zagreb, Croatia
KBC Rijeka, Endokrinologija
🇭🇷Rijeka, Primorsko - Goranska Županija, Croatia
Opca bolnica Karlovac
🇭🇷Karlovac, Croatia
Specijalna bolnica Krapinske Toplice - Endokrinologija
🇭🇷Krapinske Toplice, Croatia
Klinicki bolnicki centar Osijek
🇭🇷Osijek, Croatia
Opca bolnica Varazdin
🇭🇷Varazdin, Croatia
Zentrum fuer klinische Studien Suedbrandenburg GmbH
🇩🇪Elsterwerda, Germany
InnoDiab Forschung GmbH
🇩🇪Essen, 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
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
🇬🇷Thessaloniki, Greece
424 Military General Training Hospital
🇬🇷Thessaloniki, Greece
"Thermi" Private Hosital
🇬🇷Thessaloniki, Greece
Bajcsy-Zsilinszky Kórház
🇭🇺Budapest, Hungary
MH Egészségügyi Központ
🇭🇺Budapest, Hungary
Heiwadai Hospital
🇯🇵Miyazaki-shi, Miyazaki, Japan
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
🇯🇵Aichi, Japan
Akaicho Clinic
🇯🇵Chiba-shi, Chiba, Japan
Tokuyama clinic
🇯🇵Chiba, Japan
Naka Kinen Clinic
🇯🇵Ibaraki, Japan
Tokyo-Eki Center-building Clinic
🇯🇵Tokyo, Japan
Fukuwa Clinic
🇯🇵Tokyo, Japan
Beata Mikłaszewicz & Dariusz Dąbrowski "CARDIAMED" s.j.
🇵🇱Legnica, Dolnośląskie, Poland
EKAMED sp. z o.o.
🇵🇱Lublin, Poland
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
🇵🇱Krakow, Malopolskie, Poland
Formed 2 Sp. z o.o.
🇵🇱Oswiecim, Malopolskie, Poland
ETG Siedlce
🇵🇱Siedlce, Masovian, Poland
NZOZ Vita-Diabetica Malgorzata Buraczyk
🇵🇱Bialystok, Podlaskie Voivodeship, Poland
Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia
🇵🇱Lodz, Wojewodztwo Lodzkie, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.
🇵🇱Ruda Slaska, Poland
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
🇵🇱Warszawa, Poland
SC Grand Med SRL
🇷🇴Oradea, Bihor, 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
🇷🇴Tirgu Mures, Mures, Romania
Novus Medical Clinica SRL
🇷🇴Ploiesti, Prahova, Romania
Mariodiab Clinic SRL
🇷🇴Brasov, Romania
Cabinet Medical Dr Geru SRL
🇷🇴Timisoara, Romania
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
🇷🇴Timisoara, Romania
Peter Farkas MD, s.r.o.
🇸🇰Sahy, Slovak Republic, Slovakia
DENTAVIA s.r.o.
🇸🇰Poprad, Slovakia
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
🇪🇸Sevilla, Spain
Hospital Infanta Luisa
🇪🇸Sevilla, Spain