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

What Was Tested

The trial (phase 3) is built around Semaglutide.

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.

It had two arms (groups): Semaglutide (experimental) and Placebo (placebo comparator).

Participants will receive semaglutide once weekly as subcutaneous (s.c., under the skin) injection added to standard of care.

Participants will receive placebo (semaglutide) once weekly as subcutaneous subcutaneous (s.c., under the skin) injection added to standard of care.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1500 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female, age greater than or equal to 18 years at the time of signing informed consent. Diagnosed with type 2 diabetes mellitus. 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.

The full record lists 11 inclusion and 12 exclusion criteria; among the exclusions: 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; personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-05-08 with completion listed for 2027-11-07.

It ran at 230 sites in United States (72), India (25), Poland (16), Russia (15), Bulgaria (12) and United Kingdom (10).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Presence of at least 3 steps Early Treatment Diabetic Retinopathy Study (ETDRS) subject level progression (time frame: Year 5).

It also tracked 21 secondary outcomes, for example Change in visual acuity in the worse seeing eye, Change in visual acuity in the better seeing eye, Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with focal/grid laser photocoagulation, Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with pan-retinal laser photocoagulation, Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with intravitreal injection with steroid and Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with vitrectomy.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 1500 people.

With 1500 participants it is a large trial for this field.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.