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

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Novo Nordisk

Status and phase

Active, not recruiting
Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Semaglutide
Drug: Placebo (semaglutide)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03811561
NN9535-4352
2017-003619-20 (Registry Identifier)
U1111-1201-6256 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

1,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1,500 participants in 2 patient groups, including a placebo group

Semaglutide
Experimental group
Description:
Participants will receive semaglutide once weekly as subcutaneous (s.c., under the skin) injection added to standard of care.
Treatment:
Drug: Semaglutide
Placebo
Placebo Comparator group
Description:
Participants will receive placebo (semaglutide) once weekly as subcutaneous subcutaneous (s.c., under the skin) injection added to standard of care.
Treatment:
Drug: Placebo (semaglutide)

Trial contacts and locations

175

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Central trial contact

Novo Nordisk

Data sourced from clinicaltrials.gov

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