Status:
COMPLETED
A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Type 2 Diabetes (T2D)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ca...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2025
Estimated Enrollment :
448 Patients enrolled
Trial Details
Trial ID
NCT06542874
Start Date
August 7 2024
End Date
October 24 2025
Last Update
December 29 2025
Active Locations (119)
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1
Southern Cal Clinical Research
Santa Ana, California, United States, 92701
2
Chase Medical Research LLC
Waterbury, Connecticut, United States, 06708
3
Fleming Island Ctr for Clin Res
Fleming Island, Florida, United States, 32003
4
Encore Medical Research LLC
Hollywood, Florida, United States, 33024