Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
- Male or female, age greater than or equal to 18 years at the time of signing informed
consent
- Diagnosed with type 2 diabetes mellitus.
- HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive).
- Eye inclusion criteria (both eyes must meet all criteria):
- Early Treatment Diabetic Retinopathy Study (ETDRS) level of 10-75 (both inclusive)
evaluated by fundus photography and confirmed by central reading centre
- No ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema
six months prior to the day of screening.
- No anticipated need for ocular or intraocular treatment for diabetic retinopathy or
diabetic macular oedema within three months after randomisation.
- Best-corrected visual acuity greater than or equal to 30 letters using the ETDRS
visual acuity protocol
- No previous treatment with pan-retinal laser photocoagulation
- No substantial non-diabetic ocular condition that, in the opinion of the
ophthalmologist, would impact diabetic retinopathy or diabetic macular oedema
progression during the trial
- No substantial media opacities that would preclude successful imaging
Exclusion Criteria:
- Any of the following: myocardial infarction, stroke, hospitalization for unstable
angina pectoris or transient ischaemic attack within the past 60 days prior to the day
of screening
- Planned coronary, carotid or peripheral artery revascularisation known on the day of
screening
- Subjects presently classified as being in New York Heart Association (NYHA) Class IV
- Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR
less than 30 ml/min/1.73 m^2
- Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or
medullary thyroid carcinoma
- Presence or history of malignant neoplasms within the past 5 years prior to the day of
screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed
- Female who is pregnant, breast-feeding or intends to become pregnant or is of
child-bearing potential and not using highly effective contraceptive methods
- Concurrent treatment with any GLP-1 receptor agonist or DPP-4 inhibitor from
randomisation.
- Receipt of any investigational medicinal product within 30 days before screening
- Previous participation in this trial. Participation is defined as randomisation
- Known or suspected hypersensitivity to trial products or related products
- Any disorder, which in the investigator's opinion might jeopardise subject's safety or
compliance with the protocol
