A Trial to Evaluate the Effect of C21 on Endothelial Dysfunction in Subjects With Type 2 Diabetes

Endothelial Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05831644
• Other study ID #: VP-C21-013
• Status: Completed
• Phase: Phase 1
• Start date: April 25, 2023
• Est. completion date: June 20, 2023

Study information

• Verified date: May 2023
• Source: Vicore Pharma AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 20, 2023
• Est. primary completion date: June 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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 <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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Endothelial Dysfunction

Intervention

Drug:
• C21
C21 is an angiotensin II type 2 receptor agonist (ATRAG)

Locations

Country	Name	City	State
Sweden	Skånes universitetssjukhus	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Vicore Pharma AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamic effect	Reactive hyperemia index (RHI) score as measured by EndoPAT (Endothelial pulse amplitude tonometry (PAT)). Normal value: RHI > 1.67. Abnormal value: RHI = 1.67. A lower RHI score following C21 compared to placebo is the desired outcome.	Maximum 15 days after first Investigational Medical Product (IMP) intake.