Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is being done to look at how well a study medicine called CagriSema helps people with diabetes lower their blood sugar. In this study the sponsor will compare two version of CagriSema injected by two different types of injection devices. Which treatment participants get is decided by chance. CagriSema is still being tested in studies and is not yet available for doctors to prescribe. The study will last for about 38 weeks.
Interventions
DRUGCagriSema
Cagrilintide and Semaglutide will be administered subcutaneously using device 1 or device 2.
Placebo matched to Cagrilintide and Placebo matched to Semaglutide will be administered subcutaneously using device 1 or device 2.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male or female (sex assigned at birth, inclusive of all gender identities). * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Diagnosed with type 2 diabetes mellitus greater than or equal to (\>=) 180 days before screening. * Glycated haemoglobin (HbA1c) 7.0-10.5 percent (%) (53-91 \[millimoles per mole\] mmol/mol) (both inclusive) as determined by the central laboratory at screening. * Stable daily dose \>= 90 days before screening of metformin at effective or maximum tolerated dose as judged by the investigator. * Body mass index (BMI) between 25.0 and 39.9 kilograms per square metre (kg/m\^2) (both inclusive) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.
Exclusion criteria
* Renal impairment with estimated Glomerular Filtration Rate (eGFR) \< 30 millilitre per minute per 1.73 square metre (mL/min/1.73 m\^2) as determined by the central laboratory at screening. * Treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. * Previous exposure to CagriSema in a clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glycated haemoglobin (HbA1c) | Baseline to week 28 | Measured as percentage-points (%-points). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weekly average cagrilintide (total) and semaglutide concentration (Cavg) based on population pharmacokinetic analyses | From baseline to week 28 | Measured in nanomoles per litre (nmol/L). |
| Change in HbA1c | From baseline to week 28 | Measured as %-points. |
| Number of Treatment Emergent Adverse Events (TEAEs) | From baseline to week 35 | Measured as count of events. |
| Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 millimoles per litre [mmol/L]), confirmed by blood glucose (BG) meter, or severe hypoglycaemic episodes (level 3) | From baseline to week 35 | Measured as count of episodes. |
Countries
Denmark, Greece, Malaysia, Serbia, Slovakia, Spain, Thailand, United States
Contacts
STUDY_DIRECTORClinical Transparency dept. 2834
Novo Nordisk A/S
Outcome results
None listed