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

August 3, 2023 updated by: Vicore Pharma AB

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Malmö, Sweden, 20502
        • Skanes universitetssjukhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment arm 1
A single dose of C21 at visit 2 followed by a single dose of placebo at visit 3.
Drug: C21
C21 is an angiotensin II type 2 receptor agonist (ATRAG)
Experimental: Treatment arm 2
A single dose of placebo at visit 2 followed by a single dose C21 at visit 3.
Drug: C21
C21 is an angiotensin II type 2 receptor agonist (ATRAG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)). 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vicore Pharma AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2023

Primary Completion (Actual)

June 16, 2023

Study Completion (Actual)

June 20, 2023

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-C21-013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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