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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2023-06-20

Brief Summary

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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).

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Detailed Description

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Conditions

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Type2diabetes Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment arm 1

A single dose of C21 at visit 2 followed by a single dose of placebo at visit 3.

Group Type EXPERIMENTAL

C21

Intervention Type DRUG

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

Treatment arm 2

A single dose of placebo at visit 2 followed by a single dose C21 at visit 3.

Group Type EXPERIMENTAL

C21

Intervention Type DRUG

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

Interventions

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C21

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No