NCT05303857CompletedPhase 4
Analyse the Effect of Semaglutide on Vascular Structure and Function in Patients With Early Type 2 Diabetes
Randomized, Double-blind, Placebo Controlled, Parallel Group, Prospective Clinical Study to Analyse the Effect of Semaglutide on Vascular Structure and Function in Patients With Early Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 11 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 107 (actual)
- First submitted
- 14 Mar 2022
- Start date
- 3 Mar 2022
- Primary completion date
- 15 Dec 2023
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Diseases
- Type 2 diabetes
- NCT number
- NCT05303857
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 107
- From 3 Mar 2022 to the primary completion date, 15 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 3 months prior to study inclusion
- Drug or alcohol abuses
- Pregnant or breast-feeding patients
- Subset of patients receiving ASL-MRI, exclusion criteria-
- Patients with contraindications to MRI, including:
- Cochlear implant
Other illness
- Any other form of diabetes mellitus than type 2 diabetes mellitus
- Uncontrolled arterial hypertension (BP ≥ 180/110 mmHg)
- Congestive heart failure (CHF) NYHA stage III and IV
- Implanted cardiac pacemaker or defibrillator, or presence of intracardiac wires
- Prosthetic heart valves
Lab values
- Patients with more than two oral blood glucose lowering medication
- HbA1c ≥ 10.5%
- Fasting plasma glucose \> 240 mg/dl
- Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m²
Other
- Use of insulin, sulfonylurea or GLP-1 analogue within the past 3 months
- Body mass index \> 40 kg/m²
- Any form of diabetic retinopathy, macular oedema
- Acute or chronic pancreatitis
- Brain aneurysm clip
- Implanted neural stimulator
- Ocular foreign bodies that might be ferromagnetic (e.g., metal shavings)
- Other implanted medical devices (e.g., insulin pumps)
- Metal shrapnel or bullets still in the body
- Severe claustrophobia
- Tattoos (as determined by the Investigator and Imager)
- Weight in excess of MRI machine capacity
Who the study is looking for
- Age of 18 - 75 years
- Diagnosis of type 2 diabetes mellitus: defined by fasting glucose ≥ 126 mg/dl or HbA1c ≥ 6,5 % or on oral single or dual blood glucose lowering medication (held constant for the last 3 months)
- HbA1c ≥ 7.0%
- Male and Female patients (females of child bearing potential must be using adequate contraceptive precautions)
- Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at screening visit
- Informed consent (§ 40 Abs. 1 Satz 3 Punkt 3 AMG) has to be given in written form
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Research Center, Department of Nephrology and Hypertension, University Hospital Erlangen Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.