Diabetes Mellitus, Type 2 MedDRA version: 21.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female, age equal to or above 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 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 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 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 250
Exclusion criteria
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 below 30 ml/min/1.73 m^2 (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. - 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Time to first 3 or more steps ETDRS subject level progression or central involved diabetic macular oedema (ciDME) in either eye 2. Change from baseline in visual acuity 3. Occurrence of treatment for diabetic retinopathy or diabetic macular oedema;Timepoint(s) of evaluation of this end point: 1. From randomisation to event 2. + 3. At year 5 | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the long-term effects of treatment with semaglutide compared to placebo, both added to standard-of-care, on diabetic retinopathy development and progression in subjects with T2D;Secondary Objective: The secondary objectives are to assess the effects of treatment with semaglutide compared to placebo, both added to standard-of-care, with regards to: - Visual acuity - Diabetic retinopathy manifestations (occurrence of diabetic macular oedema or proliferative diabetic retinopathy) - Diabetic retinopathy treatments (laser photocoagulation, intravitreal agents and vitrectomy) - Modifiable risk factors for diabetic retinopathy (glycaemia, blood pressure and lipids).;Primary end point(s): Presence of 3 or more steps ETDRS (Early Treatment Diabetic Retinopathy Study) subject level progression;Timepoint(s) of evaluation of this end point: At year 5 | — |
Countries
Brazil, Bulgaria, Canada, Czech Republic, European Union, Germany, Greece, India, Israel, Latvia, Mexico, Portugal, Romania, Russian Federation, Serbia, Slovakia, Spain, United Kingdom, United States
Contacts
Public ContactClinical Transparency (2834)
Novo Nordisk A/S
Outcome results
None listed