Clinical trial • Phase III • Endocrinology
SEMAGLUTIDE for Type 2 diabetes | Diabetic retinopathy
Phase III trial of SEMAGLUTIDE for Type 2 diabetes | Diabetic retinopathy.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Type 2 diabetes | Diabetic retinopathy
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 22-12-2023
- First CTIS Authorization Date
- 12-02-2024
Trial design
Randomised, placebo: semaglutide placebo, solution for injection in 1.5 ml pre-filled pds290 pen injector (placebo arm). active investigational product: ozempic (semaglutide) 1 mg solution for injection in pre-filled pen; administered subcutaneously via pds290 pen (device can deliver 0.25 mg, 0.5 mg and 1 mg doses).-controlled Phase III trial across 68 sites in Romania, Latvia, Greece and others.
- Randomised
- Yes
- Comparator
- Placebo: Semaglutide placebo, solution for injection in 1.5 mL pre-filled PDS290 pen injector (placebo arm). Active investigational product: Ozempic (semaglutide) 1 mg solution for injection in pre-filled pen; administered subcutaneously via PDS290 pen (device can deliver 0.25 mg, 0.5 mg and 1 mg doses).
- Target Sample Size
- 878
- Trial Duration For Participant
- 1825
Eligibility
Recruits 878 isVulnerablePopulationSelected: false; participants are adults (age ≥18 years) and informed consent is obtained from the participant. Subject information and informed consent forms are listed in multiple country/language versions..
- Vulnerable Population
- isVulnerablePopulationSelected: false; participants are adults (age ≥18 years) and informed consent is obtained from the participant. Subject information and informed consent forms are listed in multiple country/language versions.
Inclusion criteria
- {"criterion_text":"- Male or female, age ≥18 years at the time of signing informed consent"}
- {"criterion_text":"- Diagnosed with type 2 diabetes mellitus."}
- {"criterion_text":"- HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive)."}
Exclusion criteria
- {"criterion_text":"- NA"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Presence of ≥3 steps ETDRS subject level progression at year 5 (yes/no).","definition_or_measurement_approach":"Measured as presence of ≥3 steps progression on the Early Treatment Diabetic Retinopathy Study (ETDRS) subject-level scale at year 5 (yes/no)."}
Secondary endpoints
- {"endpoint_text":"- Time from randomisation to first ≥3 steps ETDRS subject level progression or ciDME in either eye (month).","definition_or_measurement_approach":"Time in months from randomisation to first occurrence of ≥3 ETDRS-step subject-level progression or centre-involving diabetic macular oedema (ciDME) in either eye."}
- {"endpoint_text":"- Supportive secondary endpoints","definition_or_measurement_approach":"Not specified in the CTIS endpoints listing."}
- {"endpoint_text":"- Change from baseline at year 5 in:","definition_or_measurement_approach":"Heading for multiple change-from-baseline secondary endpoints at year 5 (details follow in subsequent endpoints)."}
- {"endpoint_text":"- Visual acuity in the worse seeing eye (number of letters)","definition_or_measurement_approach":"Measured as number of letters read on ETDRS chart in the worse-seeing eye."}
- {"endpoint_text":"- Visual acuity in the better seeing eye (number of letters)","definition_or_measurement_approach":"Measured as number of letters read on ETDRS chart in the better-seeing eye."}
- {"endpoint_text":"- Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye during the period from randomisation to year 5 with:","definition_or_measurement_approach":"Occurrence (yes/no) of specified treatments for DR or DME between randomisation and year 5."}
- {"endpoint_text":"- Focal/grid laser photocoagulation (yes/no)","definition_or_measurement_approach":"Recorded as yes/no whether focal/grid laser photocoagulation was performed."}
- {"endpoint_text":"- Pan-retinal laser photocoagulation (yes/no)","definition_or_measurement_approach":"Recorded as yes/no whether pan-retinal laser photocoagulation was performed."}
- {"endpoint_text":"- Intravitreal injection with anti-VEGF (yes/no)","definition_or_measurement_approach":"Recorded as yes/no whether intravitreal anti-VEGF injections were administered."}
- {"endpoint_text":"- Intravitreal injection with steroid (yes/no)","definition_or_measurement_approach":"Recorded as yes/no whether intravitreal steroid injections were administered."}
- {"endpoint_text":"- Vitrectomy (yes/no)","definition_or_measurement_approach":"Recorded as yes/no whether vitrectomy was performed."}
- {"endpoint_text":"- Presence of:","definition_or_measurement_approach":"Heading for a list of presence/absence endpoints (details follow in subsequent endpoints)."}
- {"endpoint_text":"- ≥3 steps ETDRS subject level improvement at year 5 (yes/no)","definition_or_measurement_approach":"Presence of improvement of ≥3 ETDRS steps at year 5 (yes/no)."}
- {"endpoint_text":"- ≥2 steps ETDRS subject level progression at year 5 (yes/no)","definition_or_measurement_approach":"Presence of progression of ≥2 ETDRS steps at year 5 (yes/no)."}
- {"endpoint_text":"- ≥2 steps ETDRS subject level improvement at year 5 (yes/no)","definition_or_measurement_approach":"Presence of improvement of ≥2 ETDRS steps at year 5 (yes/no)."}
- {"endpoint_text":"- Persistent visual acuity ≤38 ETDRS letters in either eye at year 5 (yes/no)","definition_or_measurement_approach":"Recorded as yes/no whether persistent VA ≤38 ETDRS letters is present in either eye at year 5."}
- {"endpoint_text":"- Persistent ≥2 lines (10 letters) ETDRS worsening in visual acuity in either eye from baseline at year 5 (yes/no","definition_or_measurement_approach":"Recorded as yes/no whether persistent worsening ≥2 ETDRS lines (10 letters) from baseline is present at year 5."}
- {"endpoint_text":"- Persistent ≥3 lines (15 letters) ETDRS worsening in visual acuity in either eye from baseline at year 5 (yes/no)","definition_or_measurement_approach":"Recorded as yes/no whether persistent worsening ≥3 ETDRS lines (15 letters) from baseline is present at year 5."}
- {"endpoint_text":"- Persistent ≥2 lines (10 letters) ETDRS improvement in visual acuity in either eye from baseline at year 5 (yes/no)","definition_or_measurement_approach":"Recorded as yes/no whether persistent improvement ≥2 ETDRS lines (10 letters) from baseline is present at year 5."}
- {"endpoint_text":"- Persistent ≥3 lines (15 letters) ETDRS improvement in visual acuity in either eye from baseline at year 5 (yes/no)","definition_or_measurement_approach":"Recorded as yes/no whether persistent improvement ≥3 ETDRS lines (15 letters) from baseline is present at year 5."}
- {"endpoint_text":"- ciDME in either eye at year 5 (yes/no)","definition_or_measurement_approach":"Presence of centre-involving diabetic macular oedema (ciDME) in either eye at year 5 (yes/no)."}
- {"endpoint_text":"- Change from baseline at year 5 in:","definition_or_measurement_approach":"Heading for physiologic and metabolic change-from-baseline endpoints at year 5 (specifics follow)."}
- {"endpoint_text":"- HbA1c (%-point)","definition_or_measurement_approach":"Change in HbA1c expressed in percentage points from baseline to year 5."}
- {"endpoint_text":"- Body weight (kg)","definition_or_measurement_approach":"Change in body weight in kilograms from baseline to year 5."}
- {"endpoint_text":"- Systolic and diastolic blood pressure (mmHg)","definition_or_measurement_approach":"Change in systolic and diastolic blood pressure (mmHg) from baseline to year 5."}
- {"endpoint_text":"- Lipids: Total-cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (mmol/L)","definition_or_measurement_approach":"Change in lipid parameters (mmol/L) from baseline to year 5."}
Recruitment
- Registry Or Advocacy Recruitment
- True, APDP Associacao Protectora Dos Diabeticos De Portugal
- Digital Remote Recruitment
- True, materials and consent forms for Direct-to-Patient (DTP) and a patient app are present in the document list (patient app consent forms and DTP SI-IC documents).
- Planned Sample Size
- 878
- Recruitment Window Months
- 102
- Consent Approach
- Informed consent is provided by adult participants (age ≥18 years). Subject information and informed consent forms (SI-IC) are provided in multiple country/language versions (documents listed for English, Portuguese, Latvian, Russian, Greek, Slovak, Spanish, Polish, Bulgarian, German, Czech and others). Male partner forms, pre-screening forms and DTP (Direct to Patient) consent materials are included among the listed documents.
Methods
- Patient search supplier contracted (third party listed with duty 'Patient search supplier').
- Engagement with patient organisation/advocacy group (APDP Associacao Protectora Dos Diabeticos De Portugal listed as a site/contact in Portugal).
- Direct-to-Patient (DTP) approaches and patient app (subject information forms include DTP and patient app consent documents).
- Site-based recruitment through participating hospitals/clinics in each member state (multiple hospital/clinic sites listed per country).
Geography
- Total Number Of Sites
- 68
- Total Number Of Participants
- 589
Romania
- Earliest CTIS Part Ii Submission Date
- 22-01-2024
- Latest Decision Or Authorization Date
- 15-02-2024
- Processing Time Days
- 24
- Number Of Sites
- 6
- Number Of Participants
- 17
Sites
- Site Name
- Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti
- Department Name
- Clinica Diabet I
- Principal Investigator Name
- Cristian Guja
- Principal Investigator Email
- cristian.guja@hotmail.com
- Contact Person Name
- Cristian Guja
- Contact Person Email
- cristian.guja@hotmail.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Cluj
- Department Name
- Centrul Clinic Judetean de Diabet Zaharat, Nutritie si Boli Metabolice
- Principal Investigator Name
- Cornelia Bala
- Principal Investigator Email
- cbala@umfcluj.ro
- Contact Person Name
- Cornelia Bala
- Contact Person Email
- cbala@umfcluj.ro
- Site Name
- Sana Monitoring S.R.L.
- Department Name
- Diabet
- Principal Investigator Name
- Dan Enculescu
- Principal Investigator Email
- dan.enculescu@sana.ro
- Contact Person Name
- Dan Enculescu
- Contact Person Email
- dan.enculescu@sana.ro
- Site Name
- Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
- Department Name
- Diabet Zaharat, Nutritie si Boli Metabolice
- Principal Investigator Name
- Adrian Vlad
- Principal Investigator Email
- vladrian@hotmail.com
- Contact Person Name
- Adrian Vlad
- Contact Person Email
- vladrian@hotmail.com
- Site Name
- Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
- Department Name
- Diabet Zaharat, Nutritie si Boli Metabolice
- Principal Investigator Name
- Ciprian Constantin
- Principal Investigator Email
- ciprian_constantin@yahoo.com
- Contact Person Name
- Ciprian Constantin
- Contact Person Email
- ciprian_constantin@yahoo.com
- Site Name
- Clinica Diabnutrimed S.R.L.
- Department Name
- Diabet
- Principal Investigator Name
- Catalina Niculescu
- Principal Investigator Email
- cniculescu_dr@yahoo.com
- Contact Person Name
- Catalina Niculescu
- Contact Person Email
- cniculescu_dr@yahoo.com
Latvia
- Earliest CTIS Part Ii Submission Date
- 22-01-2024
- Latest Decision Or Authorization Date
- 13-02-2024
- Processing Time Days
- 22
- Number Of Sites
- 5
- Number Of Participants
- 49
Sites
- Site Name
- Daces Teterovskas arsta prakse endokrinologija SIA
- Principal Investigator Name
- Dace Teterovska
- Principal Investigator Email
- dace.fonds@inbox.lv
- Contact Person Name
- Dace Teterovska
- Contact Person Email
- dace.fonds@inbox.lv
- Site Name
- Pauls Stradins Clinical University Hospital
- Principal Investigator Name
- Valdis Pirags
- Principal Investigator Email
- pirags@latnet.lv
- Contact Person Name
- Valdis Pirags
- Contact Person Email
- pirags@latnet.lv
- Site Name
- Zemgales diabeta centrs SIA
- Principal Investigator Name
- Sigita Pastare
- Principal Investigator Email
- pastare.sigita@gmail.com
- Contact Person Name
- Sigita Pastare
- Contact Person Email
- pastare.sigita@gmail.com
- Site Name
- Veselibas centru apvieniba AS
- Principal Investigator Name
- Inguta Stura
- Principal Investigator Email
- inguta_stura@inbox.lv
- Contact Person Name
- Inguta Stura
- Contact Person Email
- inguta_stura@inbox.lv
- Site Name
- Veselibas centru apvieniba AS
- Principal Investigator Name
- Inga Rezgale
- Principal Investigator Email
- inga_rezgale@yahoo.com
- Contact Person Name
- Inga Rezgale
- Contact Person Email
- inga_rezgale@yahoo.com
Greece
- Earliest CTIS Part Ii Submission Date
- 22-01-2024
- Latest Decision Or Authorization Date
- 22-03-2024
- Processing Time Days
- 60
- Number Of Sites
- 5
- Number Of Participants
- 25
Sites
- Site Name
- Athens Medical Center S.A.
- Department Name
- Department of Internal Medicine & Diabetes
- Principal Investigator Name
- Gerasimos Karousos
- Principal Investigator Email
- gkarousosmd@gmail.com
- Contact Person Name
- Gerasimos Karousos
- Contact Person Email
- gkarousosmd@gmail.com
- Site Name
- University General Hospital Attikon
- Department Name
- 2nd Department of Internal Medicine
- Principal Investigator Name
- Vaia Lambadiari
- Principal Investigator Email
- vlambad@otenet.gr
- Contact Person Name
- Vaia Lambadiari
- Contact Person Email
- vlambad@otenet.gr
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- Diabetes Centre
- Principal Investigator Name
- Nikolaos Tentolouris
- Principal Investigator Email
- ntentol@med.uoa.gr
- Contact Person Name
- Nikolaos Tentolouris
- Contact Person Email
- ntentol@med.uoa.gr
- Site Name
- Thermi Clinic S.A.
- Department Name
- Department of Internal Medicine
- Principal Investigator Name
- Emmanouil Pagkalos
- Principal Investigator Email
- epagkalos@gmail.com
- Contact Person Name
- Emmanouil Pagkalos
- Contact Person Email
- epagkalos@gmail.com
- Site Name
- Hippokration Hospital
- Department Name
- Diabetology Clinic
- Principal Investigator Name
- Ioanna Zografou
- Principal Investigator Email
- ioannazo@yahoo.gr
- Contact Person Name
- Ioanna Zografou
- Contact Person Email
- ioannazo@yahoo.gr
Slovakia
- Earliest CTIS Part Ii Submission Date
- 22-01-2024
- Latest Decision Or Authorization Date
- 13-02-2024
- Processing Time Days
- 22
- Number Of Sites
- 3
- Number Of Participants
- 32
Sites
- Site Name
- University Hospital Bratislava
- Department Name
- Ambulancia diabetologie a poruch latkovej premeny a vyzivy
- Principal Investigator Name
- Katarina Cerna
- Principal Investigator Email
- kce@centrum.sk
- Contact Person Name
- Katarina Cerna
- Contact Person Email
- kce@centrum.sk
- Site Name
- DIA Zilina s.r.o.
- Department Name
- Ambulancia diabetologie a poruch latkovej premeny a vyzivy
- Principal Investigator Name
- Iveta Kurcova
- Principal Investigator Email
- kurcovaiveta@gmail.com
- Contact Person Name
- Iveta Kurcova
- Contact Person Email
- kurcovaiveta@gmail.com
- Site Name
- Medivasa s.r.o.
- Department Name
- Ambulancia diabetologie a poruch latkovej premeny a vyzivy
- Principal Investigator Name
- Ingrid Buganova
- Principal Investigator Email
- buganova@medivasa.sk
- Contact Person Name
- Ingrid Buganova
- Contact Person Email
- buganova@medivasa.sk
Spain
- Earliest CTIS Part Ii Submission Date
- 22-01-2024
- Latest Decision Or Authorization Date
- 19-02-2024
- Processing Time Days
- 28
- Number Of Sites
- 6
- Number Of Participants
- 57
Sites
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Principal Investigator Name
- Juan Francisco Merino Torres
- Principal Investigator Email
- merino_jfr@gva.es
- Contact Person Name
- Juan Francisco Merino Torres
- Contact Person Email
- merino_jfr@gva.es
- Site Name
- Hospital Universitario Virgen De La Macarena
- Principal Investigator Name
- Estanislao Gutiérrez Sánchez
- Principal Investigator Email
- esgusan@hotmail.com
- Contact Person Name
- Estanislao Gutiérrez Sánchez
- Contact Person Email
- esgusan@hotmail.com
- Site Name
- Clinica Universidad De Navarra
- Principal Investigator Name
- Alfredo García Layana
- Principal Investigator Email
- aglayana@unav.es
- Contact Person Name
- Alfredo García Layana
- Contact Person Email
- aglayana@unav.es
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Principal Investigator Name
- Alfonso Soto González
- Principal Investigator Email
- alfonso.soto.gonzalez@sergas.es
- Contact Person Name
- Alfonso Soto González
- Contact Person Email
- alfonso.soto.gonzalez@sergas.es
- Site Name
- Vall D'hebron Institut De Recerca
- Principal Investigator Name
- Rafael Simó Canonge
- Principal Investigator Email
- rafael.simo@vhir.org
- Contact Person Name
- Rafael Simó Canonge
- Contact Person Email
- rafael.simo@vhir.org
- Site Name
- Bellvitge University Hospital
- Principal Investigator Name
- Eduard Montanya
- Principal Investigator Email
- montanya@ub.edu
- Contact Person Name
- Eduard Montanya
- Contact Person Email
- montanya@ub.edu
Poland
- Earliest CTIS Part Ii Submission Date
- 22-01-2024
- Latest Decision Or Authorization Date
- 16-02-2024
- Processing Time Days
- 25
- Number Of Sites
- 11
- Number Of Participants
- 111
Sites
- Site Name
- Gdanska Poradnia Cukrzycowa Sp. z o.o.
- Principal Investigator Name
- Piotr Romanczuk
- Principal Investigator Email
- piotrrom@wp.pl
- Contact Person Name
- Piotr Romanczuk
- Contact Person Email
- piotrrom@wp.pl
- Site Name
- Gaja Poradnie Lekarskie Maciej Wiza
- Principal Investigator Name
- Dorota Pisarczyk-Wiza
- Principal Investigator Email
- wizus@wp.pl
- Contact Person Name
- Dorota Pisarczyk-Wiza
- Contact Person Email
- wizus@wp.pl
- Site Name
- Pratia S.A.
- Principal Investigator Name
- Anna Siegel
- Principal Investigator Email
- hankasiegel@gmail.com
- Contact Person Name
- Anna Siegel
- Contact Person Email
- hankasiegel@gmail.com
- Site Name
- Prywatny Gabinet Lekarski Jan Ruxer
- Principal Investigator Name
- Jan Ruxer
- Principal Investigator Email
- ruxer@poczta.fm
- Contact Person Name
- Jan Ruxer
- Contact Person Email
- ruxer@poczta.fm
- Site Name
- NZOZ "DiabMed" Poradnia Diabetologiczna
- Principal Investigator Name
- Beata Szperkowska-Pordab
- Principal Investigator Email
- beaszp@wp.pl
- Contact Person Name
- Beata Szperkowska-Pordab
- Contact Person Email
- beaszp@wp.pl
- Site Name
- In Vivo Sp. z o.o.
- Principal Investigator Name
- Radoslaw Wieczor
- Principal Investigator Email
- wieczorcmumk@tlen.pl
- Contact Person Name
- Radoslaw Wieczor
- Contact Person Email
- wieczorcmumk@tlen.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Bialymstoku
- Department Name
- Centrum Badan Klinicznych
- Principal Investigator Name
- Adam Kretowski
- Principal Investigator Email
- adam.kretowski@umb.edu.pl
- Contact Person Name
- Adam Kretowski
- Contact Person Email
- adam.kretowski@umb.edu.pl
- Site Name
- Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
- Department Name
- Poradnia Diabetologiczna
- Principal Investigator Name
- Janusz Gumprecht
- Principal Investigator Email
- jgumprecht@sum.edu.pl
- Contact Person Name
- Janusz Gumprecht
- Contact Person Email
- jgumprecht@sum.edu.pl
- Site Name
- Futuremeds Sp. z o.o.
- Department Name
- Krakowskie Centrum Medyczne
- Principal Investigator Name
- Piotr Rozpondek
- Principal Investigator Email
- piotr.rozpondek@futuremeds.com
- Contact Person Name
- Piotr Rozpondek
- Contact Person Email
- piotr.rozpondek@futuremeds.com
- Site Name
- Synexus Polska Sp. z o.o.
- Principal Investigator Name
- Marek Cesarz
- Principal Investigator Email
- marek.cesarz@globalaes.com
- Contact Person Name
- Marek Cesarz
- Contact Person Email
- marek.cesarz@globalaes.com
- Site Name
- Santa Sp. z o.o.
- Principal Investigator Name
- Krystyna Opawska
- Principal Investigator Email
- krystyna.opawska@swietarodzina.com.pl
- Contact Person Name
- Krystyna Opawska
- Contact Person Email
- krystyna.opawska@swietarodzina.com.pl
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 22-01-2024
- Latest Decision Or Authorization Date
- 21-03-2024
- Processing Time Days
- 59
- Number Of Sites
- 11
- Number Of Participants
- 132
Sites
- Site Name
- Meditsinski Tsentar Vitklinik EOOD
- Principal Investigator Name
- Margarita Vitkina
- Principal Investigator Email
- margarita.vitkina@abv.bg
- Contact Person Name
- Margarita Vitkina
- Contact Person Email
- margarita.vitkina@abv.bg
- Site Name
- MBAL Sveti Pantaleimon OOD
- Department Name
- Department of Internal Diseases
- Principal Investigator Name
- Lyuba Yordanova
- Principal Investigator Email
- iordanova.l@abv.bg
- Contact Person Name
- Lyuba Yordanova
- Contact Person Email
- iordanova.l@abv.bg
- Site Name
- Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD
- Department Name
- Department of Endocrinology and Metabolic Diseases
- Principal Investigator Name
- Ivaylo Lefterov
- Principal Investigator Email
- ilefterov@abv.bg
- Contact Person Name
- Ivaylo Lefterov
- Contact Person Email
- ilefterov@abv.bg
- Site Name
- Diagnostic Consultation Center XX-Sofia EOOD
- Department Name
- Endocrinology Consulting Room
- Principal Investigator Name
- Katya Kurteva
- Principal Investigator Email
- katiakurteva@abv.bg
- Contact Person Name
- Katya Kurteva
- Contact Person Email
- katiakurteva@abv.bg
- Site Name
- University Multiprofile Hospital For Active Treatment Saint Georgi EAD
- Department Name
- Clinic of Endocrinology and Metabolic Diseases
- Principal Investigator Name
- Mariya Orbetzova
- Principal Investigator Email
- morbetzova@abv.bg
- Contact Person Name
- Mariya Orbetzova
- Contact Person Email
- morbetzova@abv.bg
- Site Name
- Diagnostic Consulting Center VII-Sofia EOOD
- Department Name
- Endocrinology Consulting Room
- Principal Investigator Name
- Galina Lazarova
- Principal Investigator Email
- galia_l@mail.bg
- Contact Person Name
- Galina Lazarova
- Contact Person Email
- galia_l@mail.bg
- Site Name
- MBAL Med Line Clinic AD
- Department Name
- Department of Endocrinology and Metabolic Diseases
- Principal Investigator Name
- Aneta Hristozova
- Principal Investigator Email
- a_hri@mail.bg
- Contact Person Name
- Aneta Hristozova
- Contact Person Email
- a_hri@mail.bg
- Site Name
- Fourth Multiprofile Hospital For Active Treatment-Sofia EAD
- Department Name
- Department of Internal Diseases
- Principal Investigator Name
- Lyudmila Lyubenova
- Principal Investigator Email
- llubenovamd@mail.bg
- Contact Person Name
- Lyudmila Lyubenova
- Contact Person Email
- llubenovamd@mail.bg
- Site Name
- Multiprofile Hospital For Active Treatment Medical Complex Sveti Ivan Rilski EOOD
- Department Name
- Department of Internal Diseases
- Principal Investigator Name
- Albena Kichukova
- Principal Investigator Email
- beni_a_d@abv.bg
- Contact Person Name
- Albena Kichukova
- Contact Person Email
- beni_a_d@abv.bg
- Site Name
- Diagnostic-Consultative Center I Pleven EOOD
- Principal Investigator Name
- Katya Todorova
- Principal Investigator Email
- todorova_kate@abv.bg
- Contact Person Name
- Katya Todorova
- Contact Person Email
- todorova_kate@abv.bg
- Site Name
- University Specialized Hospital For Active Treatment In Endocrinology Akad. Iv. Penchev EAD
- Department Name
- Second Clinic of Endocrinology and Metabolic Diseases
- Principal Investigator Name
- Tsvetalina Tankova
- Principal Investigator Email
- tankova@iname.com
- Contact Person Name
- Tsvetalina Tankova
- Contact Person Email
- tankova@iname.com
Portugal
- Earliest CTIS Part Ii Submission Date
- 22-01-2024
- Latest Decision Or Authorization Date
- 12-02-2024
- Processing Time Days
- 21
- Number Of Sites
- 8
- Number Of Participants
- 85
Sites
- Site Name
- APDP Associacao Protectora Dos Diabeticos De Portugal
- Principal Investigator Name
- João Filipe Raposo
- Principal Investigator Email
- filipe.raposo@apdp.pt
- Contact Person Name
- João Filipe Raposo
- Contact Person Email
- filipe.raposo@apdp.pt
- Site Name
- Unidade Local De Saude De Matosinhos E.P.E.
- Principal Investigator Name
- Francisco Carvalho
- Principal Investigator Email
- francisco.simoescarvalho@ulsm.min-saude.pt
- Contact Person Name
- Francisco Carvalho
- Contact Person Email
- francisco.simoescarvalho@ulsm.min-saude.pt
- Site Name
- Centro Hospitalar Do Baixo Vouga E.P.E. (CHBV E.P.E.)
- Principal Investigator Name
- Joana Guimarães
- Principal Investigator Email
- Joana.Costa.11364@chbv.min-saude.pt
- Contact Person Name
- Joana Guimarães
- Contact Person Email
- Joana.Costa.11364@chbv.min-saude.pt
- Site Name
- Hospital Garcia De Orta E.P.E.
- Principal Investigator Name
- Henrique Vara Luiz
- Principal Investigator Email
- hvaraluiz@gmail.com
- Contact Person Name
- Henrique Vara Luiz
- Contact Person Email
- hvaraluiz@gmail.com
- Site Name
- Hospital Da Senhora Da Oliveira Guimaraes E.P.E.
- Principal Investigator Name
- Cristina Cunha
- Principal Investigator Email
- cristinacunha@hospitaldeguimaraes.min-saude.pt
- Contact Person Name
- Cristina Cunha
- Contact Person Email
- cristinacunha@hospitaldeguimaraes.min-saude.pt
- Site Name
- Unidade Local De Saude Da Arrabida E.P.E.
- Principal Investigator Name
- Julieta Sousa
- Principal Investigator Email
- julieta.sousa@chs.min-saude.pt
- Contact Person Name
- Julieta Sousa
- Contact Person Email
- julieta.sousa@chs.min-saude.pt
- Site Name
- Centro Hospitalar E Universitario De Coimbra E.P.E.
- Principal Investigator Name
- José Miguel Melo
- Principal Investigator Email
- 8359@ulscoimbra.min-saude.pt
- Contact Person Name
- José Miguel Melo
- Contact Person Email
- 8359@ulscoimbra.min-saude.pt
- Site Name
- Centro Hospitalar Universitario Sao Joao E.P.E.
- Principal Investigator Name
- João Neves
- Principal Investigator Email
- joao.sergio.neves@chsj.min-saude.pt
- Contact Person Name
- João Neves
- Contact Person Email
- joao.sergio.neves@chsj.min-saude.pt
Germany
- Earliest CTIS Part Ii Submission Date
- 22-01-2024
- Latest Decision Or Authorization Date
- 15-02-2024
- Processing Time Days
- 24
- Number Of Sites
- 7
- Number Of Participants
- 34
Sites
- Site Name
- Institut fuer Diabetesforschung Muenster GmbH
- Principal Investigator Name
- Ludger Rose
- Principal Investigator Email
- l.rose@diabetes-muenster.de
- Contact Person Name
- Ludger Rose
- Contact Person Email
- l.rose@diabetes-muenster.de
- Site Name
- Zentrum für klinische Studien Alexander Segner
- Principal Investigator Name
- Alexander Segner
- Principal Investigator Email
- alexander.segner@zks-igb.de
- Contact Person Name
- Alexander Segner
- Contact Person Email
- alexander.segner@zks-igb.de
- Site Name
- Denger, Friedrichsthal
- Principal Investigator Name
- Ralf Denger
- Principal Investigator Email
- dr.denger@saarprax.de
- Contact Person Name
- Ralf Denger
- Contact Person Email
- dr.denger@saarprax.de
- Site Name
- Diabetes-Zentrum-Wilhelmsburg GbR
- Principal Investigator Name
- Peter Witzel
- Principal Investigator Email
- p.witzel@diabetes-zentrum-wilhelmsburg.de
- Contact Person Name
- Peter Witzel
- Contact Person Email
- p.witzel@diabetes-zentrum-wilhelmsburg.de
- Site Name
- Gemeinschaftspraxis für Innere Medizin (Wendisch/Dahl Hamburg)
- Principal Investigator Name
- Dominik Dahl
- Principal Investigator Email
- dr.dahl@dzhw.de
- Contact Person Name
- Dominik Dahl
- Contact Person Email
- dr.dahl@dzhw.de
- Site Name
- Praxis Dr. med. Wenzl-Bauer
- Principal Investigator Name
- Veronika Wenzl-Bauer
- Principal Investigator Email
- wenzl.studien@gmail.com
- Contact Person Name
- Veronika Wenzl-Bauer
- Contact Person Email
- wenzl.studien@gmail.com
- Site Name
- Schwerpunktpraxis für Diabetes und Ernährungsmedizin
- Principal Investigator Name
- Winfried Keuthage
- Principal Investigator Email
- keuthage@diabetes-praxis-muenster.de
- Contact Person Name
- Winfried Keuthage
- Contact Person Email
- keuthage@diabetes-praxis-muenster.de
Czechia
- Earliest CTIS Part Ii Submission Date
- 22-01-2024
- Latest Decision Or Authorization Date
- 19-02-2024
- Processing Time Days
- 28
- Number Of Sites
- 6
- Number Of Participants
- 47
Sites
- Site Name
- Diainmed s.r.o.
- Principal Investigator Name
- Jana Psottova
- Principal Investigator Email
- jana.psottova@gmail.com
- Contact Person Name
- Jana Psottova
- Contact Person Email
- jana.psottova@gmail.com
- Site Name
- Fakultni Nemocnice Brno
- Principal Investigator Name
- Jana Belobradkova
- Principal Investigator Email
- belobradkova.jana@fnbrno.cz
- Contact Person Name
- Jana Belobradkova
- Contact Person Email
- belobradkova.jana@fnbrno.cz
- Site Name
- Institute For Clinical And Experimental Medicine
- Principal Investigator Name
- Terezie Pelikanova
- Principal Investigator Email
- tepe@ikem.cz
- Contact Person Name
- Terezie Pelikanova
- Contact Person Email
- tepe@ikem.cz
- Site Name
- MUDr. Michala Pelikanova s.r.o.
- Principal Investigator Name
- Michala Pelikanova
- Principal Investigator Email
- pelikanova.michala@seznam.cz
- Contact Person Name
- Michala Pelikanova
- Contact Person Email
- pelikanova.michala@seznam.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Principal Investigator Name
- Alena Šmahelová
- Principal Investigator Email
- smahelov@lfhk.cuni.cz
- Contact Person Name
- Alena Šmahelová
- Contact Person Email
- smahelov@lfhk.cuni.cz
- Site Name
- Fakultní Nemocnice Královské Vinohrady
- Principal Investigator Name
- Pavel Skrha
- Principal Investigator Email
- pavel.skrha@email.cz
- Contact Person Name
- Pavel Skrha
- Contact Person Email
- pavel.skrha@email.cz
Sponsor
Primary sponsor
- Full Name
- Novo Nordisk A/S
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Denmark
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- Patient search supplier; (also listed among third parties with other duties)
- Name
- Klinitrial Limited
- Responsibilities
- Visual acuity certification
- Name
- Perceptive Eclinical Limited
- Responsibilities
- IWRS supplier
Third parties
- {"country":"United Kingdom","full_name":"Klinitrial Limited","duties_or_roles":"Visual acuity certification","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Oracle America Inc.","duties_or_roles":"eCRF supplier","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"International Drug Development Institute","duties_or_roles":"Independent External statistical Supplier","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"University Of Wisconsin","duties_or_roles":"Central reading centre","organisation_type":"Educational Institution"}
- {"country":"United Kingdom","full_name":"Perceptive Eclinical Limited","duties_or_roles":"IWRS supplier","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Laservision Ambulatory Eye Surgery Unit","duties_or_roles":"lab exams of ophthalmology","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Patient search supplier","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Patient search supplier","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Ozempic 1 mg solution for injection in pre-filled pen
- Active Substance
- SEMAGLUTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- Subcutaneous injection
- Authorisation Status
- Marketing authorisation exists for product (EU MA EU/1/17/1251/005) but clinical study product is a clinical variant assembled for trial use
- Dose Levels
- 0.25 mg, 0.5 mg, 1 mg (device can deliver these doses)
- Maximum Dose
- 1 mg
- Investigational Product Name
- Semaglutide placebo, solution for injection in 1.5 mL pre-filled PDS290 pen injector
- Modality
- Other
- Authorisation Status
- Not authorised (placebo for trial use)
- Combination Treatment
- Yes
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