A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 Diabetes
Diabetes Mellitus, Type 2This study will look at how well a new medicine called NNC0519-0130 helps people with type 2 diabetes lower their blood sugar and body weight. The study will test up to 7 different doses of NNC0519-0130. Which treatment participant will get is decided by chance. Participants will take 1-3 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 40 weeks.
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Participation Requirements
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Sex:
ALL -
Eligible Ages:
18 to 75
Participation Criteria
Inclusion Criteria:
* Female of non-childbearing potential, or male.
* For United States (US) only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency and willingness to continue using it through-out the study or male.
* Age 18-75 years (both inclusive) at the time of signing the informed consent.
* Diagnosed with type 2 diabetes mellitus greater than or equal 180 days before screening.
* Stable daily dose(s) more than or equal 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 sodium-glucose co-transporter 2 (SGLT2) inhibitor.
* Glycated haemoglobin (HbA1c) of 7.5-10.0% (58-86 millimoles per moles (mmol/mol)) (both inclusive) as assessed by central laboratory at screening.
* Body mass index (BMI) greater than or equal 23.0 kilograms per meter square (kg/m\^2).
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.
Study Location
OCT Research ULC (dba Okanagan Clinical Trials)
OCT Research ULC (dba Okanagan Clinical Trials)Richmond, British Columbia
Canada
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Nova Scotia Hlth Halifax
Nova Scotia Hlth HalifaxHalifax, Nova Scotia
Canada
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Centricity Research Quebec City
Centricity Research Quebec CityLevis, Quebec
Canada
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G.A. Research Associates Ltd.
G.A. Research Associates Ltd.Moncton, New Brunswick
Canada
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OCT Research ULC (dba Okanagan Clinical Trials)
OCT Research ULC (dba Okanagan Clinical Trials)Kelowna, British Columbia
Canada
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Albion Finch Medical Centre
Albion Finch Medical CentreToronto, Ontario
Canada
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Wharton Med Clin Trials
Wharton Med Clin TrialsHamilton, Ontario
Canada
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Recherche GCP Research
Recherche GCP ResearchMontreal, Quebec
Canada
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Cook Street Medical Clinic
Cook Street Medical ClinicVictoria, British Columbia
Canada
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Centricity Research Ville St. Laurent VSL
Centricity Research Ville St. Laurent VSLVille Saint-Laurent, Quebec
Canada
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- Study Sponsored By
- Novo Nordisk A/S
- Participants Required
- More Information
- Study ID:
NCT06326047