Analyse the Effect of Semaglutide on Vascular Structure and Function in Patients With Early Type 2 Diabetes
Status:
Recruiting
Trial end date:
2024-06-30
Target enrollment:
Participant gender:
Summary
This is a phase IV, randomized (1:1), prospective, double-blind, placebo controlled,
parallel-group, single center study at the Clinical Research Unit (CRC) of the Department of
Nephrology and Hypertension, with its two separate locations:
- Nürnberg, Kreuzburger Str. 2, 90471 Nürnberg, and
- Erlangen, Ulmenweg 18, 91054 Erlangen The main goal of the study is to demonstrate the
effect of semaglutide on different vascular parameters of the macro- and
microcirculation. The primary objective is to analyze the effect of semaglutide,
compared to placebo on central (aortic) pulse pressure.
At least 90 patients will be randomized (1:1) and included (informed consent, intention to
treat population) in order to obtain 80 fully evaluable subjects (per protocol population).
Patients will be simultaneously recruited from investigator's outpatient clinics, referring
physicians, and advertisement in local newspapers, and social media. Those patients that
appear to potentially fulfill the inclusion criteria will be invited to a screening visit
(visit 1). After providing informed consent, patients will be tested for inclusion/exclusion
criteria. Patients will provide a blood sample for laboratory testing. If the patient then
fulfills inclusion criteria and in the absence of exclusion criteria, the patient will be
enrolled into the trial, and the study visits will be scheduled. Randomization will take
place at the latest one day prior to the study visit 2 (e.g. at the latest at visit 2a).
At visit 2 (2a and 2b), baseline vascular function parameters will be obtained and the
patient will be given a SC injection of the study drug (either SC 0.25 mg semaglutide or SC
placebo). After giving detailed instructions to the patient how to apply the injections, the
patient will be advised to apply the injection once weekly. A safety visit will be conducted
1 week after first administration of study drug (visit 3). At visit 4 and 5, semaglutide will
be up-titrated to 0.5 mg and 1.0 mg respectively. At visit 6, a safety visit will be
conducted and the dose of semaglutide will be kept at 1.0 mg. After 16 weeks of treatment
(visits 7a and 7b), testing of vascular function will be repeated. At visit 7b, a final close
out visit will be performed to gather additional safety information.