Clinical trial • Not applicable • Endocrinology
SEMAGLUTIDE for Type 2 diabetes
Not applicable trial of SEMAGLUTIDE for Type 2 diabetes. 70 participants. CTIS 2024-518682-95.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Type 2 diabetes
- Trial Stage
- Not applicable
- Drug Modality
- Peptide/protein/enzyme | Small molecule
Key dates
- Initial CTIS Submission Date
- 21-10-2024
- First CTIS Authorization Date
- 09-02-2025
Trial design
Not applicable trial across 2 sites in Denmark, Spain.
- Target Sample Size
- 70
Eligibility
Recruits 70 No vulnerable population selected (isVulnerablePopulationSelected=false). The trial is in adult patients; no assent process or other vulnerable-population consent arrangements are described in the available record. Subject information and informed consent documents are provided (titles present in documents list)..
- Pregnancy Exclusion
- Pregnancy or planed pregnancy.
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected=false). The trial is in adult patients; no assent process or other vulnerable-population consent arrangements are described in the available record. Subject information and informed consent documents are provided (titles present in documents list).
Inclusion criteria
- {"criterion_text":"- Type 2 diabetes with no clinical signs of heart failure, cardiovascular disease or diabetic kidney disease."}
Exclusion criteria
- {"criterion_text":"- Manifest cardiovascular disease, heart failure (left ventricular ejection fraction <45%), micro- or macroalbuminuria with a urine albumin creatine ratio ≥ 200 mg/g or chronic kidney disease with an eGFR < 45 ml/min/1.73m2. Pregnancy or planed pregnancy."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Feasibility","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Changes in urinary albumin excretion (≥30%), changes in urinary proteomic signatures and changes in eGFR levels (≥30%)","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 70
- Recruitment Window Months
- 27
- Consent Approach
- Informed consent forms are provided (document titles in record include: L1_ICF 2024-518682-95_ES; L1_SIS 2024-518682-95; L1_Informed consent form; L1_Informed consent form Biobank; L2_Other subject information material Forsgspersoners rettigheder). Consent is by the participant (adult subjects). Language indicators in document titles include ES (Spanish) and DK (Danish) versions; no assent process or age-specific consent handling is described in the available record.
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 70
Denmark
- Earliest CTIS Part Ii Submission Date
- 17-01-2025
- Latest Decision Or Authorization Date
- 20-02-2026
- Processing Time Days
- 399
- Number Of Sites
- 1
- Number Of Participants
- 50
Sites
- Site Name
- Steno Diabetes Center Copenhagen
- Department Name
- Complications Research
- Contact Person Name
- Peter Rossing
- Contact Person Email
- peter.rossing@regionh.dk
Spain
- Earliest CTIS Part Ii Submission Date
- 24-04-2025
- Latest Decision Or Authorization Date
- 03-09-2025
- Processing Time Days
- 132
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Servicio de Nefrología, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain
- Contact Person Name
- Beatriz Fernandez-Fernandez
- Contact Person Email
- BFernandez@fjd.es
Sponsor
Primary sponsor
- Full Name
- Steno Diabetes Center Copenhagen
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
Third parties
- {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- SEMAGLUTIDE
- Active Substance
- SEMAGLUTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- Authorised
- Maximum Dose
- 29 µg per day (max daily); max total amount: 52 mg
- Investigational Product Name
- FINERENONE
- Active Substance
- FINERENONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Maximum Dose
- 20 mg per day (max daily); max total amount: 3640 mg
- Investigational Product Name
- DAPAGLIFLOZIN
- Active Substance
- DAPAGLIFLOZIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Maximum Dose
- 10 mg per day (max daily); max total amount: 1820 mg
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