Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Matthew Freeby (ucla)

Description

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 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.

Official Title

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

Keywords

Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 2 Diabetes Mellitus, Semaglutide

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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 m2
  • 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

Locations

  • Scripps Whittier Diabetes Inst
    La Jolla California 92037 United States
  • FDRC
    Costa Mesa California 92627 United States
  • Diabetes/Lipid Mgmt & Res Ctr
    Huntington Beach California 92648 United States
  • Downtown LA Res Ctr. Inc.
    Los Angeles California 90017 United States
  • Southern California Res Ctr
    Coronado California 92118 United States
  • Torrance Clin Res Inst, Inc.
    Lomita California 90717 United States
  • Clinical Trials Research_Sacramento_0
    Sacramento California 95821 United States
  • Diablo Clinical Research, Inc.
    Walnut Creek California 94598 United States

Lead Scientist at University of California Health

  • Matthew Freeby (ucla)
    HS Associate Clinical Professor, Medicine. Authored (or co-authored) 32 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novo Nordisk A/S
ID
NCT03811561
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1500 study participants
Last Updated