Overview
Sponsor-declared trial summary
Type 2 diabetes
To determine by means of 18F-FDG PET/CT and 99mTc-Tetrofosmin SPECT whether myocardial IR affects cardiac function and coronary flow and is therefore a risk factor for cardiovascular events and diabetic cardiomyopathy in DM2 patients with myocardial IR phenotype
Key facts
- Sponsor
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18], Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2025-12-23
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Ministerio de Ciencia, Innovación y Universidades
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Others
To determine by means of 18F-FDG PET/CT and 99mTc-Tetrofosmin SPECT whether myocardial IR affects cardiac function and coronary flow and is therefore a risk factor for cardiovascular events and diabetic cardiomyopathy in DM2 patients with myocardial IR phenotype
Secondary objectives 2
- To find biomarkers through metabolomic and lipidomic studies that can be related to myocardial IR, cardiac function and coronary flow, as well as the relationship between them to manage DM2 patients in a personalized way
- Effect of semaglutide and dapaglifozin on myocardium insulin resistance
Conditions and MedDRA coding
Type 2 diabetes
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2025-523374-17-00 | Insulin resistance in type 2 diabetes: evaluating the pathogenic mechanisms of insulin resistance in the myocardium and the effects of the treatments with GLP-1RA and SGLT2i | Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- BMI around 30 kg/m2
- DM2
- no-smoking; no-alcohol
- HbA1c between 7-9%
Exclusion criteria 4
- previous CVD events
- hepatic and kidney complications
- claustrophobia to PET/CT and SPECT
- treatment with SGLT2 inhibitors or GLP-1 analogs.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Myocardium insulin resistance
Secondary endpoints 2
- Coronary flow
- Heart function
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Ozempic 1 mg solution for injection in pre-filled pen
PRD12647197 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 375000 µg microgram(s)
- Max total dose
- 6 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/17/1251/015
- MA holder
- NOVO NORDISK A/S
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Dapagliflozin 10 mg film-coated tablets
PRD11393404 · Product
- Active substance
- Dapagliflozin Propanediol
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 1120 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BK01 — -
- Marketing authorisation
- PL 36390/0448
- MA holder
- CIPLA (EU) LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Sponsor organisation
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Address
- Passeig De La Vall D'Hebron 119-129
- City
- Barcelona
- Postcode
- 08035
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Contact name
- Olga Simó Servat
Public contact point
- Organisation
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Contact name
- Olga Simó Servat
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Not authorised | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Synopis EU CT 2025-523374-17-01 | 1 |
| Protocol (for publication) | Protocolo modelo medicamentos | 1 |
| Protocol (for publication) | Protocolo modelo medicamentos version 2 cambios aceptados | 1 |
| Protocol (for publication) | Protocolo modelo medicamentos version 2 contorl de cambios | 1 |
| Recruitment arrangements (for publication) | Recruitment and Informed consent procedure | 1 |
| Subject information and informed consent form (for publication) | Anexo proteccion de datos | 1 |
| Subject information and informed consent form (for publication) | Anexo proteccion de datos V2 CONTROL DE CAMBIOS | 1 |
| Subject information and informed consent form (for publication) | Anexo proteccion de datosv2 | 1 |
| Subject information and informed consent form (for publication) | HIP CI V2 | 1 |
| Subject information and informed consent form (for publication) | HIP-CI-proyectos | 1 |
| Subject information and informed consent form (for publication) | HIP-CI-proyectos version 2 control de cambios | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | FichaTecnicaDapagliflozina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | ficheTecnicaSemaglutide | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopis EU CT 2025-523374-17-01 | 1 |
| Synopsis of the protocol (for publication) | Synopsis of the protocol in english | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-01 | Spain | Acceptable with conditions 2025-12-22
|
2025-12-23 |