Diabetes Mellitus, Type 2
Conditions
Brief summary
This 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.
Interventions
DRUGNNC0519-0130
NNC0519-0130 will be administered subcutaneously.
DRUGPlacebo
Placebo will be administered subcutaneously.
DRUGTrizepatide
Trizepatide will be administered subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures. The study will be double-blinded within dose level of once weekly subcutaneously administered NNC0519-0130 and the corresponding volume-matched placebo arms. The active comparator arm with tirzepatide will be open label.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycated haemoglobin (HbA1c) | From baseline (week 0) to 12 weeks on a given maintenance dose | Measured as percentage point (%-point) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in body weight | From baseline (week 0) to end of treatment (week 36) | Measured as percentage (%) |
| Change in body weight | From baseline (week 0) to end of treatment (week 36) | Measured as kilograms (kg) |
| Change in fasting plasma glucose (FPG) | From baseline (week 0) to 12 weeks on a given maintenance dose | Measured as millimoles per liter (mmol/L) |
| Continuous glucose monitoring (CGM): Change in time in range (TIR) 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL)) | From baseline (week -2 to week 0) to week 22-24 and week 34-36, respectively | Measured as percentage point (%-point) |
| Change in waist circumference | From baseline (week 0) to end of treatment (week 36) | Measured as centimeter (cm) |
| Change in systolic blood pressure (SBP) | From baseline (week 0) to end of treatment (week 36) | Measured as millimeters of mercury (mmHg) |
| Change in Glycated haemoglobin (HbA1c) | From baseline (week 0) to end of treatment (week 36) | Measured as percentage point (%-point) |
| Change in total cholesterol | From baseline (week 0) to end of treatment (week 36) | Measured as ratio to baseline |
| Change in high-density lipoprotein (HDL) cholesterol | From baseline (week 0) to end of treatment (week 36) | Measured as ratio to baseline |
| Change in low-density lipoprotein (LDL) cholesterol | From baseline (week 0) to end of treatment (week 36) | Measured as ratio to baseline |
| Change in triglycerides | From baseline (week 0) to end of treatment (week 36) | Measured as ratio to baseline |
| Number of adverse events | From baseline (week 0) to end of study (week 40) | Measured as number of events |
| Change in high sensitivity C-Reactive Protein (hsCRP) | From baseline (week 0) to end of treatment (week 36) | Measured as ratio to baseline |
Countries
Australia, Canada, India, Japan, South Africa, South Korea, United States
Outcome results
None listed