Status:
ACTIVE_NOT_RECRUITING
A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will look at the long-term effects of semaglutide (active medicine) on diabetic eye disease when compared to placebo (dummy medicine). The study will be performed in people with type 2 diab...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 7 2027
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT03811561
Start Date
May 8 2019
End Date
November 7 2027
Last Update
December 26 2025
Active Locations (229)
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1
Synexus Rsch /Cnt Phnx Med C
Phoenix, Arizona, United States, 85050
2
Del Sol Research Management, LLC
Tucson, Arizona, United States, 85715
3
South Arizona VA Healthcare System
Tucson, Arizona, United States, 85723
4
Synexus Cln Rsrch Inc - Orange Gro FP
Tucson, Arizona, United States, 85741