A Trial to Evaluate the Effect of C21 on Endothelial Dysfunction in Subjects With Type 2 Diabetes
Type2diabetes, Endothelial Dysfunction

About this trial
This is an interventional basic science trial for Type2diabetes
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 <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.
Sites / Locations
- Skånes universitetssjukhus
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Treatment arm 1
Treatment arm 2
A single dose of C21 at visit 2 followed by a single dose of placebo at visit 3.
A single dose of placebo at visit 2 followed by a single dose C21 at visit 3.