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

VP-C21-013

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).

2023-04-25

2023-06-16

2023-06-20

Completed

Early phase I

11

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 11, 'type': 'ACTUAL'}}

2023-08-04