A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes

  • Interventional
  • Recruiting
  • NCT03811561
Eligibility Details Visit Clinicaltrials.gov

Long-term Effects of Semaglutide on Diabetic Retinopathy in Subjects With Type 2 Diabetes

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 diabetes. Participants will either get semaglutide or placebo in addition to their diabetes medicines - which treatment the participant gets is decided by chance. Participants will inject the study medicine using a pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. The study will last for 5 years.


Age Group
18 Years and up

Accepting Healthy Volunteers?

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

At a Glance

National Government IDNCT03811561


Lead SponsorNovo Nordisk A/S

Lead PhysicianLouis Philipson


18 Years and up