Clinical trial • Not applicable • Endocrinology|Cardiology
Semaglutide for Type 2 diabetes
Not applicable trial of Semaglutide for Type 2 diabetes.
Overview
- Trial Therapeutic Area
- Endocrinology|Cardiology
- Trial Disease
- Type 2 diabetes
- Trial Stage
- Not applicable
- Drug Modality
- Peptide/protein/enzyme|Small molecule
Key dates
- Initial CTIS Submission Date
- 01-09-2025
- First CTIS Authorization Date
- 22-12-2025
Trial design
Dapagliflozin 10 mg film-coated tablets (oral) — Comparator (product: Dapagliflozin 10 mg; max daily dose 10 mg).-controlled Not applicable trial across 1 site in Spain.
- Comparator
- Dapagliflozin 10 mg film-coated tablets (oral) — Comparator (product: Dapagliflozin 10 mg; max daily dose 10 mg).
- Target Sample Size
- 60
Eligibility
Recruits 60 No vulnerable populations selected..
- Vulnerable Population
- No vulnerable populations selected.
Inclusion criteria
- {"criterion_text":"-BMI around 30 kg/m2\n-DM2\n-no-smoking; no-alcohol\n-HbA1c between 7-9%"}
Exclusion criteria
- {"criterion_text":"-previous CVD events\n-hepatic and kidney complications\n-claustrophobia to PET/CT and SPECT\n-treatment with SGLT2 inhibitors or GLP-1 analogs."}
Endpoints
Primary endpoints
- {"endpoint_text":"-Myocardium insulin resistance","definition_or_measurement_approach":"Assessment by 18F-FDG PET/CT and 99mTc-Tetrofosmin SPECT to determine myocardial insulin resistance (as described in main objective)."}
Secondary endpoints
- {"endpoint_text":"-Coronary flow","definition_or_measurement_approach":"Measured using imaging methods (18F-FDG PET/CT and 99mTc-Tetrofosmin SPECT) as indicated in objectives."}
- {"endpoint_text":"-Heart function","definition_or_measurement_approach":"Measured using imaging methods (18F-FDG PET/CT and 99mTc-Tetrofosmin SPECT) as indicated in objectives."}
Recruitment
- Planned Sample Size
- 60
- Recruitment Window Months
- 22
- Consent Approach
- Informed consent obtained from participants; subject information and informed consent form documents are listed in trial documents (Subject information and informed consent form / Anexo proteccion de datos). No vulnerable populations selected.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 60
Spain
- Earliest CTIS Part Ii Submission Date
- 24-11-2025
- Latest Decision Or Authorization Date
- 23-12-2025
- Processing Time Days
- 29
- Number Of Sites
- 1
- Number Of Participants
- 60
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Endocrinology
- Principal Investigator Name
- Olga Simó Servat
- Principal Investigator Email
- olga.simo@vallhebron.cat
- Contact Person Name
- Olga Simó Servat
- Contact Person Email
- olga.simo@vallhebron.cat
- Number Of Participants
- 60
Sponsor
Primary sponsor
- Full Name
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Spain
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
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised (marketing authorisation EU/1/17/1251/015)
- Maximum Dose
- 6 mg (maxTotalDoseAmount)
- Investigational Product Name
- Dapagliflozin 10 mg film-coated tablets
- Active Substance
- Dapagliflozin propanediol
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketing authorisation PL 36390/0448)
- Starting Dose
- 10 mg
- Dose Levels
- 10 mg
- Maximum Dose
- 1120 mg (maxTotalDoseAmount)
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