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: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Any other form of diabetes mellitus than type 2 diabetes mellitus

• Use of insulin, sulfonylurea or GLP-1 analogue within the past 3 months

• Patients with more than two oral blood glucose lowering medication

• HbA1c ≥ 10.5%

• Body mass index > 40 kg/m²

• Fasting plasma glucose > 240 mg/dl

• Any form of diabetic retinopathy, macular oedema

• Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m²

• Acute or chronic pancreatitis

• Uncontrolled arterial hypertension (BP ≥ 180/110 mmHg)

• Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 3 months prior to study inclusion

• Congestive heart failure (CHF) NYHA stage III and IV

• Drug or alcohol abuses

• Pregnant or breast-feeding patients