Study on the Effects of Semaglutide on Diabetic Eye Disease in People with Type 2 Diabetes

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What is this study about?

This clinical trial is focused on understanding the long-term effects of the medication semaglutide on a condition called diabetic retinopathy in people with type 2 diabetes. Diabetic retinopathy is an eye disease that can occur in individuals with diabetes, potentially leading to vision problems. The study will compare the effects of semaglutide, which is administered as a solution for injection, to a placebo. The purpose of the study is to assess how semaglutide affects the development and progression of diabetic retinopathy when added to the usual care for type 2 diabetes.

Participants in the study will receive either semaglutide or a placebo through a pre-filled pen injector, which allows for easy administration under the skin. The study will take place over several years, during which participants will undergo regular eye examinations to monitor any changes in their condition. These assessments will help determine if semaglutide has a beneficial effect on preventing or slowing down the progression of diabetic retinopathy compared to the placebo.

The study aims to provide valuable insights into the safety and effectiveness of semaglutide for individuals with type 2 diabetes who are at risk of developing diabetic retinopathy. By participating in this research, it is hoped that new information will be gathered to improve the management and treatment of this eye condition in the future.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age (18 years or older), a diagnosis of type 2 diabetes, and specific HbA1c levels (7.0-10.0%).

2 initial assessment

An initial assessment is conducted to establish baseline measurements. This includes evaluating visual acuity and other eye health indicators using standardized ophthalmic assessments.

3 treatment administration

Participants receive either semaglutide or a placebo. The medication is administered as a subcutaneous injection using a pre-filled pen. The specific dosage and frequency are determined by the study protocol.

4 ongoing monitoring

Regular monitoring occurs throughout the study to track the development and progression of diabetic retinopathy. This includes periodic eye examinations and assessments of visual acuity.

5 yearly evaluations

Annual evaluations are conducted to assess changes in eye health and other health indicators. These evaluations include measuring visual acuity and checking for any progression in diabetic retinopathy.

6 final assessment

At the end of the study period, a comprehensive assessment is performed to evaluate the long-term effects of the treatment on diabetic retinopathy. This includes a final eye examination and comparison with baseline measurements.

Who Can Join the Study?

  • Must be a male or female who is at least 18 years old at the time of signing the consent form.
  • Must have been diagnosed with type 2 diabetes mellitus, which is a condition where the body does not use insulin properly.
  • Must have an HbA1c level between 7.0% and 10.0%. HbA1c is a blood test that shows the average level of blood sugar over the past 2 to 3 months.

Who Cannot Join the Study?

  • Patients who have a history of severe allergic reactions to the study medication or similar medications cannot participate.
  • Individuals with a current or past history of certain eye diseases, other than diabetic retinopathy, may be excluded.
  • Patients with uncontrolled high blood pressure, which means their blood pressure is not well-managed, are not eligible.
  • People with severe kidney disease, which affects how well the kidneys work, cannot join the study.
  • Participants who have had a heart attack or stroke within the last 6 months are not allowed to participate.
  • Individuals with a history of certain types of cancer may be excluded from the study.
  • Pregnant or breastfeeding women cannot take part in the trial.
  • Patients who are currently participating in another clinical trial are not eligible.
  • Individuals with a history of drug or alcohol abuse may be excluded from the study.
  • People with certain mental health conditions that might affect their ability to follow the study procedures cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
MBAL Med Line Clinic AD Plovdiv Bulgaria
Diabetes-Zentrum-Wilhelmsburg GbR Hamburg Germany
Spitalul Clinic Judetean De Urgenta Cluj Cluj Napoca Romania
Centro Hospitalar Universitario Sao Joao E.P.E. Porto Portugal
Futuremeds Sp. z o.o. Wroclaw Poland
Hospital Universitario De Navarra Pamplona Spain
Institutul National de Diabet, Nutritie si Boli Metabolice “N.C. Paulescu” Bucharest Romania

Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia
Unidade Local De Saude De Almada-Seixal E.P.E. Almada Portugal
University Hospital Bratislava Bratislava Slovakia
Santa Sp. z o.o. Lodz Poland
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Medivasa s.r.o. Zilina Slovakia
MBAL Sveti Pantaleimon OOD Pleven Bulgaria
Sana Monitoring S.R.L. Bucharest Romania
Thermi Clinic S.A. Thessaloniki Greece
Gdanska Poradnia Cukrzycowa Sp. z o.o. Gdansk Poland
APDP Associacao Protectora Dos Diabeticos De Portugal Lisbon Portugal
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Hippokration Hospital Athens Greece
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD Sofia Bulgaria
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Romania
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Hospital Universitario Virgen Macarena Sevilla Spain
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Synexus Polska Sp. z o.o. Poznan Poland
Pratia S.A. Skorzewo Poland
In Vivo Sp. z o.o. Bydgoszcz Poland
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila Bucharest Romania
Centro Hospitalar Do Baixo Vouga E.P.E. (CHBV E.P.E.) Aveiro Portugal
Centro Hospitalar de Setubal E.P.E. Setubal Portugal
Veselibas centru apvieniba AS Riga Latvia
Institut fuer Diabetesforschung Muenster GmbH Munster Germany
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
MUDr. Michala Pelikanova s.r.o. Prague Czechia
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Cspbbha Dkndsyxspkbz Saxxks Bucharest Romania
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Nefj &cvevhkjlyyycximoyzko Pfhkbmbe Dpzsjimmfzxvzdk Poznan Poland
Mpivhoceedc Txcjqse Vuawbcvan Egsa Sofia Bulgaria
Dyekgxjucs Cjjvgprlad Ckxfyd Vrwfozbnu Edak Sofia Bulgaria
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Pzdbrk Dqn mxyn Wpulesoiocj Rehlingen-Siersburg Germany
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Lvotu Gvofxvu Hayhnlop Oc Agxavn Athens Greece
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Sxngzpgfjjefbwsqq fvb Dwrlyifh uqv Evctebclywaqmroja Dcv myjn Woblxfyh Khlitvbp Munster Germany
Maujsfh Cwwjfj Avwln Iie Pvnbbac Epcc Sofia Bulgaria
Hrwwxokt Vjjz dagyhfwv Barcelona Spain
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Crrolv Hnlownvgjp E Ufzvlkbpxtkpy De Cqrxinp Edjrcm Coimbra Portugal

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
08.05.2019
Czechia Czechia
Not recruiting
08.05.2019
Germany Germany
Not recruiting
08.05.2019
Greece Greece
Not recruiting
08.05.2019
Latvia Latvia
Not recruiting
08.05.2019
Poland Poland
Not recruiting
08.05.2019
Portugal Portugal
Not recruiting
08.05.2019
Romania Romania
Not recruiting
08.05.2019
Slovakia Slovakia
Not recruiting
08.05.2019
Spain Spain
Not recruiting
08.05.2019

Trial locations

Investigated drugs:

Semaglutide is a medication used in this clinical trial to evaluate its long-term effects on diabetic retinopathy in individuals with type 2 diabetes. It is added to the standard care that patients are already receiving. The goal is to see if semaglutide can help prevent or slow down the progression of diabetic retinopathy, which is a complication of diabetes that affects the eyes.

Diabetic Retinopathy – Diabetic retinopathy is a complication of diabetes that affects the eyes. It occurs when high blood sugar levels cause damage to the blood vessels in the retina, the light-sensitive tissue at the back of the eye. In the early stages, there may be no symptoms, but as the condition progresses, it can lead to vision problems. Over time, the damaged blood vessels can leak fluid or bleed, leading to vision impairment. In advanced stages, new abnormal blood vessels can grow, which can further worsen vision. Regular eye examinations are crucial for individuals with diabetes to monitor and manage this condition.

Trial ID:
2023-506827-26-00
Protocol code:
NN9535-4352
Trial Phase:
Therapeutic confirmatory (Phase III)

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