| Trial ID: | L2874 |
| Source ID: | NCT05831644
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| Associated Drug: |
C21
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| Title: |
A Trial to Evaluate the Effect of C21 on Endothelial Dysfunction in Subjects With Type 2 Diabetes
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT05831644/results
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| Conditions: |
Type2diabetes|Endothelial Dysfunction
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| Interventions: |
DRUG: C21
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| Outcome Measures: |
Primary: Pharmacodynamic Effect, Reactive hyperemia index (RHI) score as measured by EndoPAT (Endothelial pulse amplitude tonometry (PAT)). The EndoPAT software, provided with the device, is calculating the RHI using a computerised, automated algorithm. Reactive Hyperemia Index (RHI) score is a post-to-pre occlusion pulse amplitude tonometry signal ratio in the occluded arm relative to the same ratio in the control arm, and corrected for baseline vascular tone. RHI is a measure of endothelial function. Normal value: RHI \> 1.67. Abnormal value: RHI ≤ 1.67. There is no theoretical minimum and/or maximum values for the RHI score. A lower RHI score following C21 compared to placebo is the desired outcome., Maximum 15 days after first Investigational Medical Product (IMP) intake. | Secondary: Augmentation Index (AI) Score as Measured by EndoPAT (Endothelial Pulse Amplitude Tonometry (PAT)). The AI Score Reported is Change Between Baseline Value and Value at the Visit Where Either C21 or Placebo is Taken., The EndoPAT software, provided with the device is calculating the the Augmentation index (AI) using a computerised, automated algorithm. Augmentation index is a measurement of vascular stiffness. Augmentation index is calculated from PAT pulses based on the following formula AIx = 100 × (Augmentation pressure)/(Pulse Pressure). Ideally the augmentation index is somewhere between 20-80, but can be both negative and positive depending on the value of the augmentation pressure. A higher value is indicative of vascular stiffness., Maximum 15 days after first Investigational Medical Product (IMP) intake.
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| Sponsor/Collaborators: |
Sponsor: Vicore Pharma AB
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE1
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| Enrollment: |
11
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
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| Start Date: |
2023-03-31
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| Completion Date: |
2023-06-20
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| Results First Posted: |
2024-11-12
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| Last Update Posted: |
2024-11-12
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| Locations: |
Skånes universitetssjukhus, Malmö, 20502, Sweden
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| URL: |
https://clinicaltrials.gov/show/NCT05831644
|
