SEMA

CompletedPhase 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

Lead sponsor

University of Erlangen-Nürnberg Medical School

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

107

Study population

Type 2 diabetes

Eligibility highlights

•HbA1c ≥6.5%

Primary endpoint

•Central (aortic) pulse pressure

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05303857

Org study IDCRC2020SEMA

Timeline

Milestones

Study start2022-03-03actual

Study first posted2022-03-31actual

Primary completion2023-12-15actual

Study completion2025-04-17actual

Last update posted2025-06-11actual

Assets

Investigational agents

Semaglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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

Subset of patients receiving ASL-MRI, exclusion criteria-

Patients with contraindications to MRI, including:

•Brain aneurysm clip

•Implanted neural stimulator

•Implanted cardiac pacemaker or defibrillator, or presence of intracardiac wires

•Prosthetic heart valves

•Cochlear implant

•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

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Other clinical outcomes

Renal / kidney

1 endpoint

Secondary/protocol endpoint

Renal perfusion of both kidneys assessed by Arterial Spin Labeling MRI

Time frame:16 weeks