Phase 1
N=11
A Trial to Evaluate the Effect of C21 on Endothelial Dysfunction in Subjects With Type 2 Diabetes
Type2diabetes · Endothelial Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT05831644 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Pharmacodynamic Effect — 1.787; 1.911 score on a scale — p=0.1925
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- C21 (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Vicore Pharma AB
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacodynamic Effect |
1.787; 1.911 | 0.1925 |
| 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. |
15.937; 20.877 | 0.1941 |
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).
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- Known, active hepatitis B, C, or human immunodeficiency virus (HIV) infection (i.e., HIV with a CD4 (cluster of differentiation 4) count 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.
Data sourced from ClinicalTrials.gov (NCT05831644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.