Clinical trial

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

Active, not recruiting · Phase 3 · 6 countries · Registry ID NCT03811561

Active, not recruitingPhase 3Interventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionDiabetes Mellitus, Type 2

Full registry criteria

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

Treatments and study arms

Semaglutide

Drug

Participants will get one dose of semaglutide once weekly in addition to their diabetes medicines - which treatment they get is decided by chance. Participants will inject the study medicine using a pre-filled PDS290 pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. Participants will start with once-weekly doses of 0.25 mg for 4 weeks, then the dose will be gradually increased to 0.5 mg once weekly for 4 weeks, and finally to 1.0 mg once weekly (maximum dose) up to 260 weeks (5 years).

Placebo (semaglutide)

Drug

Participants will get one dose of placebo (semaglutide) once weekly in addition to their diabetes medicines - which treatment they get is decided by chance. Participants will inject the study medicine using a pre-filled PDS290 pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. Participants will start with once-weekly doses of 0.25 mg for 4 weeks, then the dose will be gradually increased to 0.5 mg once weekly for 4 weeks, and finally to 1.0 mg once weekly (maximum dose) up to 260 weeks (5 years).

Primary outcomes

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

Percentage of subjects (yes/no).

Study locations

229 locations were listed when this page was built. The first 40 are shown.

CPQuali Pesquisa Clínica Ltda🇧🇷 São Paulo, São Paulo, Brazil
DCC I- Pleven EOOD Endocrinology🌐 Pleven, Bulgaria
MHAT Sveti Pantaleimon - Pleven, Internal Diseases🌐 Pleven, Bulgaria
MHAT MC-Sv Ivan Rilski EOOD🌐 Plovdiv, Bulgaria
MHAT Med Line Clinic🌐 Plovdiv, Bulgaria
UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Endocrinology🌐 Plovdiv, Bulgaria
"DCC VII - Sofia", Endocrinology Consulting Room🌐 Sofia, Bulgaria
DCC VII - Sofia EOOD, Endocrinology🌐 Sofia, Bulgaria
DCC XX - Sofia EOOD, Endocrinology🌐 Sofia, Bulgaria
IV MHAT - Sofia EAD🌐 Sofia, Bulgaria
MHAT Knyaginya Klementina - Sofia EAD🌐 Sofia, Bulgaria
Medical centre Vitclinic EOOD🌐 Sofia, Bulgaria
USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology🌐 Sofia, Bulgaria
LMC Clinical Res Thornhill🇨🇦 Concord, Ontario, Canada
Alberta Diabetes Institute🇨🇦 Edmonton, Alberta, Canada
LMC Endo Ctr (Etobicoke) Ltd🇨🇦 Etobicoke, Ontario, Canada
LMC Clinical Research, Inc. (Montreal Glen)🇨🇦 Montreal, Quebec, Canada
LMC Oakville🇨🇦 Oakville, Ontario, Canada
The Ottawa Hospital Riverside Campus🇨🇦 Ottawa, Ontario, Canada
Centricity Res Pointe-Claire🇨🇦 Pointe-Claire, Quebec, Canada
LMC Clin Rsrch Inc. (Montreal)🇨🇦 Saint-Laurent, Quebec, Canada
LMC Endo Centres Ltd.(Bayview)🇨🇦 Toronto, Ontario, Canada
Fakultni nemocnice Brno🇨🇿 Brno, Czechia
Fakultni nemocnice Hradec Kralove🇨🇿 Hradec Králové, Czechia
Diabetologie Krupska🇨🇿 Prague, Czechia
Fakultni nemocnice Kralovske Vinohrady_Praha🇨🇿 Prague, Czechia
Institut klinicke a experimentalni mediciny🇨🇿 Prague, Czechia
MUDr. Michala Pelikanova🇨🇿 Prague, Czechia
Praxis Denger/Pfitzner, Friedrichsthal🇩🇪 Friedrichsthal, Germany
Diabetes-Zentrum-Wilhelmsburg GbR🇩🇪 Hamburg, Germany
Diabetologische Schwerpunktpraxis Harburg- Dr. med.Paschen,🇩🇪 Hamburg, Germany
Wendisch - Dahl Hamburg - DZHW🇩🇪 Hamburg, Germany
Wendisch/Dahl Hamburg🇩🇪 Hamburg, Germany
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose🇩🇪 Münster, Germany
MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin🇩🇪 Münster, Germany
Praxis Dr. med. Wenzl-Bauer🇩🇪 Rehlingen-Siersburg, Germany
Zentrum für klinische Studien Alexander Segner🇩🇪 Saint Ingbert-Oberwürzbach, Germany
"Laiko" General Hospital of Athens🇬🇷 Athens, Greece
"Laiko" General Hospital of Athens🇬🇷 Athens, Greece
Iatriko Athinon 'Palaiou Falirou'🇬🇷 Athens, Greece