A research study to look at how semaglutide compared to placebo affects diabetic eye disease in people with type 2 diabetes
- Conditions
- Diabetes Mellitus, Type 2MedDRA version: 20.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2017-003619-20-ES
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 1500
- Male or female, age equal to or above18 years at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus at least10 years prior to the day of screening.
- HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive).
Eye inclusion criteria (both eyes must meet the following criteria):
- 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 twelve months prior to the day of screening.
- No anticipated need for ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema within six months after randomisation.
- Best-corrected visual acuity equal to or above 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300
- 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 below 30 ml/min/1.73 m2 (Based on medical history using latest available and no more than 6 months old assessment. If not available in medical records a local laboratory measurement must be made available before randomisation).
- 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.
- Current or previous (within 30 days before screening) treatment with any GLP-1 receptor agonist or DPP-4 inhibitor.
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method