Type2diabetesPhase 1NCT05831644
A Trial to Evaluate the Effect of C21 on Endothelial Dysfunction in Subjects With Type 2 Diabetes
A Phase 1 study testing C21 in people with Type2diabetes and Endothelial Dysfunction, run by Vicore Pharma AB at 1 site in Sweden.
Trial summary
This trial is a single-centre, randomized, double-blind, placebo-controlled, 2-way cross-over phase 1b trial evaluating the pharmacodynamic effect of C21 on endothelial dysfunction and safety in subjects with type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Type2diabetes, Endothelial Dysfunction
- What is being tested?
- C21
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSweden
- Study dates
- 31 Mar 2023to 20 Jun 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient aged ≥ 40 years at the time of the screening visit (Visit 1).
- Documented diagnosed with T2DM prior to the screening visit (Visit 1).
- An RHI score ≤ 2 as assessed by EndoPAT at the time of the screening visit (Visit 1).
Who cannot join
- Known, active hepatitis B, C, or human immunodeficiency virus (HIV) infection (i.e., HIV with a CD4 (cluster of differentiation 4) count <500 cells/mm³).
- Impaired hepatic function or clinically significant liver disease, which in the investigator's opinion makes the subject inappropriate for this trial.
- Severe renal impairment (i.e., estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m2).
- Prolonged QTcF (QT interval with Fridericia's correction) (>450 ms), atrial fibrillation, clinically significant arrhythmia or other clinically significant abnormality in the resting ECG (electrocardiogram) at screening (Visit 1), as judged by the investigator.
- Unstable or deteriorating cardiac condition.
- Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, 2-way Cross-over Trial Evaluating the Effect of C21 on Endothelial Dysfunction and Safety in Subjects With Type 2 Diabetes Mellitus
This trial is a single-centre, randomized, double-blind, placebo-controlled, 2-way cross-over phase 1b trial evaluating the pharmacodynamic effect of C21 on endothelial dysfunction and safety in subjects with type 2 diabetes mellitus (T2DM).
- Conditions
- Type2diabetes, Endothelial Dysfunction
- Being tested
- C21
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C21Drug
C21 is an angiotensin II type 2 receptor agonist (ATRAG)
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm 1 | Experimental | A single dose of C21 at visit 2 followed by a single dose of placebo at visit 3. Receives: Drug: C21 |
| Treatment arm 2 | Experimental | A single dose of placebo at visit 2 followed by a single dose C21 at visit 3. Receives: Drug: C21 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Maximum 15 days after first Investigational Medical Product (IMP) intake.
Secondary outcomes (1)
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.
Measured: Maximum 15 days after first Investigational Medical Product (IMP) intake.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start31 Mar 2023
- Primary completion16 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type2diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vicore Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831644
- Sponsor's protocol ID
- VP-C21-013
- Other IDs
- 2023-000168-77, 2023
- Status last verified
- Sep 2024
- First submitted
- 13 Mar 2023
- Last updated
- 12 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, 2-way Cross-over Trial Evaluating the Effect of C21 on Endothelial Dysfunction and Safety in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05831644
- Acronym / sponsor ID
- VP-C21-013
- Conditions
- Type2diabetes, Endothelial Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Vicore Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 26 Apr 2023 (actual)
- Results
- Posted 12 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a single-centre, randomized, double-blind, placebo-controlled, 2-way cross-over phase 1b trial evaluating the pharmacodynamic effect of C21 on endothelial dysfunction and safety in subjects with type 2 diabetes mellitus (T2DM).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm 1 | Experimental | Drug: C21A single dose of C21 at visit 2 followed by a single dose of placebo at visit 3. |
| Treatment arm 2 | Experimental | Drug: C21A single dose of placebo at visit 2 followed by a single dose C21 at visit 3. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patient aged ≥ 40 years at the time of the screening visit (Visit 1).
- Documented diagnosed with T2DM prior to the screening visit (Visit 1).
- An RHI score ≤ 2 as assessed by EndoPAT at the time of the screening visit (Visit 1).
Key exclusion criteria (6 listed)
- Known, active hepatitis B, C, or human immunodeficiency virus (HIV) infection (i.e., HIV with a CD4 (cluster of differentiation 4) count <500 cells/mm³).
- Impaired hepatic function or clinically significant liver disease, which in the investigator's opinion makes the subject inappropriate for this trial.
- Severe renal impairment (i.e., estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m2).
- Prolonged QTcF (QT interval with Fridericia's correction) (>450 ms), atrial fibrillation, clinically significant arrhythmia or other clinically significant abnormality in the resting ECG (electrocardiogram) at screening (Visit 1), as judged by the investigator.
- Unstable or deteriorating cardiac condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C21C21 is an angiotensin II type 2 receptor agonist (ATRAG) | Drug | Treatment arm 1, Treatment arm 2 |
Primary outcome
Pharmacodynamic Effect
Time frame: Maximum 15 days after first Investigational Medical Product (IMP) intake.
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.
1 secondary outcome
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.
Time frame: Maximum 15 days after first Investigational Medical Product (IMP) intake.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing C21 in people with Type2diabetes and Endothelial Dysfunction, run by Vicore Pharma AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacodynamic Effect (time frame: Maximum 15 days after first Investigational Medical Product (IMP) intake.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.