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Analyse the Effect of Semaglutide on Vascular Structure and Function in Patients With Early Type 2 Diabetes

NCT05303857 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2025-06-11

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Semaglutide Pen Injector

Injection of the semaglutide once weekly

DRUG

Placebo

Injection of placebo once weekly

Sponsors & Collaborators

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Roalnd E Schmieder, MD · University Hospital Erlangen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-03
Primary Completion
2023-12-15
Completion
2025-04-17

Countries

  • Germany

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05303857 on ClinicalTrials.gov