A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes
Launched by NOVO NORDISK A/S · Aug 5, 2024
Trial Information
Current as of November 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medicine called NNC0487-0111 to see how well it can lower blood sugar levels and body weight in people with type 2 diabetes. The study is open to both men and women aged 18 to 75 who have been diagnosed with type 2 diabetes for at least 6 months. Participants need to be stable on certain diabetes medications like metformin and have a specific blood sugar level. If you join, you will randomly receive either the new medicine (which can be taken as a tablet or injection) or a placebo (a treatment that looks like the medicine but has no active ingredients).
The trial will last about 43 weeks, and during this time, you'll wear a continuous glucose monitoring device to help track your blood sugar levels. It's important to be aware that participants will not be able to use other diabetes medications during the study, aside from those specified. If you meet the eligibility criteria and are interested in helping us learn more about this new treatment, your contribution could make a difference for many people with diabetes.
Gender
ALL
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.
About Novo Nordisk A/S
Novo Nordisk A/S is a global healthcare company headquartered in Denmark, specializing in the research, development, manufacturing, and marketing of innovative pharmaceuticals, particularly in the fields of diabetes care, obesity treatment, and hormone replacement therapies. With a strong commitment to improving patient outcomes, Novo Nordisk invests significantly in clinical trials to advance scientific knowledge and develop effective therapies. The company is dedicated to sustainability and ethical practices, striving to deliver high-quality healthcare solutions while addressing the evolving needs of patients worldwide. Through collaboration and innovation, Novo Nordisk aims to lead the way in transforming diabetes and other chronic diseases into manageable conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Barcelona, Spain
Chicago, Illinois, United States
Nashville, Tennessee, United States
Madrid, Spain
A Coruña, Spain
Santander, Spain
Oxon Hill, Maryland, United States
Rapid City, South Dakota, United States
Statesville, North Carolina, United States
Houston, Texas, United States
Waco, Texas, United States
Waterbury, Connecticut, United States
Karlovac, Croatia
La Coruña, Spain
Presov, Slovakia
Debrecen, Hungary
Sevilla, Spain
Tokyo, Japan
Budapest, Hungary
Nashville, Tennessee, United States
Essen, Germany
Santa Ana, California, United States
Chesterfield, Missouri, United States
Gyula, Hungary
Lampasas, Texas, United States
Troy, Michigan, United States
Houston, Texas, United States
Sevilla, Spain
Debrecen, Hungary
Sevilla, Spain
Debrecen, Hungary
Morehead City, North Carolina, United States
Chiba, Japan
Mckinney, Texas, United States
Albany, New York, United States
Dallas, Texas, United States
Houston, Texas, United States
Elsterwerda, Germany
Hamburg, Germany
Münster, Germany
Aichi, Japan
Ibaraki, Japan
Legnica, Dolnośląskie, Poland
Houston, Texas, United States
Plovdiv, Bulgaria
Oldenburg In Holstein, Germany
Chiba Shi, Chiba, Japan
Tokyo, Japan
Krakow, Malopolskie, Poland
Castilleja Dela Cuesta Sevilla, Spain
Paducah, Kentucky, United States
Hyattsville, Maryland, United States
Kyustendil, Bulgaria
Plovdiv, Bulgaria
Krapinske Toplice, Croatia
Athens, Greece
Thessaloniki, Greece
Thessaloniki, Greece
Siedlce, Masovian, Poland
Bialystok, Podlaskie Voivodeship, Poland
Bucharest, Bucurestii, Romania
Tirgu Mures, Mures, Romania
Zagreb, Grad Zagreb, Croatia
Osijek, Croatia
Brasov, Romania
Lodz, Poland
Miramar, Florida, United States
Rijeka, Primorsko Goranska županija, Croatia
Varazdin, Croatia
Budapest, Hungary
Cluj Napoca, Cluj, Romania
Oradea, Bihor, Romania
Timisoara, Romania
Orlando, Florida, United States
Sofia, Bulgaria
Ploiesti, Prahova, Romania
Warszawa, Poland
Lampasas, Texas, United States
Miyazaki Shi, Miyazaki, Japan
Sofia, Bulgaria
Varna, Bulgaria
Legnica, Poland
Sevilla, Spain
Thessaloniki, Greece
Poprad, Slovakia
Pittsburgh, Pennsylvania, United States
Rimavska Sobota, Slovakia
Oswiecim, Malopolskie, Poland
Lodz, Wojewodztwo Lodzkie, Poland
Goudi/Athens, Greece
Ruda Slaska, Poland
Sahy, Slovak Republic, Slovakia
Fargo, North Dakota, United States
Hollywood, Florida, United States
Fleming Island, Florida, United States
Sofia, Bulgaria
Athens, Greece
Debrecen, Hungary
Kaposvár, Hungary
Bialystok, Poland
Lublin, Poland
Timisoara, Romania
Zilina, Slovakia
Santa Ana, California, United States
Kaposvár, Hungary
Thessaloniki, Greece
Thessaloniki, Greece
Lublin, Lubelskie, Poland
Bialystok, Podlaskie, Poland
Hamburg, Germany
Troy, Michigan, United States
Thessaloniki, Greece
Krapinske Toplice, Croatia
Rijeka, Croatia
Tokyo, Japan
Chiba, Japan
Tokyo, Japan
Kyustendil, Bulgaria
Miyazaki Shi, Miyazaki, Japan
Ibaraki, Japan
Albany, New York, United States
Krakow, Lesser Poland Voivodeship, Poland
Oświęcim, Lesser Poland Voivodeship, Poland
Legnica, Lower Silesian Voivodeship, Poland
Warsaw, Poland
Timișoara, Romania
Miyazaki, Miyazaki, Japan
Plovdiv, Bulgaria
Zagreb, City Of Zagreb, Croatia
Rijeka, Primorje Gorski Kotar County, Croatia
Varaždin, Croatia
Varaždin, Croatia
Miyazaki, Miyazaki, Japan
Lublin, Lublin Voivodeship, Poland
Siedlce, Masovian Voivodeship, Poland
Bialystok, Podlaskie Voivodeship, Poland
Ruda śląska, Poland
Oradea, Bihor County, Romania
Cluj Napoca, Cluj, Romania
Târgu Mureş, Romania
Ploieşti, Prahova, Romania
Timișoara, Romania
šahy, Slovak Republic, Slovakia
Prešov, Slovakia
Rimavská Sobota, Slovakia
žilina, Slovakia
Seville, Spain
Seville, Spain
Seville, Spain
Seville, Spain
Patients applied
Trial Officials
Clinical Transparency (dept. 2834)
Study Director
Novo Nordisk A/S
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported