Effect of Empagliflozin and Semaglutide on the Cardiovascular system and Kidneys in patients with type 2 diabetes – A randomized Trial

Phase 1

• Conditions: Type 2 Diabetes Mellitus; MedDRA version: 20.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2019-000781-38-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-14
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Diagnose of type 2 diabetes.
HbA1c level of 7% (53 mmol/mol) or more.
Age of 50 years or more with established cardiovascular disease (prior myocardial infarction, prior stroke or prior transient ischemic attack, prior coronary, carotid or peripheral arterial revascularization, more than 50 % stenosis on angiography or imaging of coronary, carotid or lower extremities arteries, history of symptomatic coronary heart disease documented by e.g. positive exercise stress test or any cardiac imaging or unstable angina with electrocardiography (ECG) changes), or chronic heart failure (New York Heart Association class II or III).
or
Age of 60 years or more with at least one cardiovascular risk factor (persistent microalbuminuria (30-299 mg/g) or proteinuria, hypertension and left ventricular hypertrophy by electrogram or imaging, left ventricular systolic or diastolic dysfunction by imaging or ankle/brachial index less than 0.9).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

Estimated glomerular filtration rate < 60 ml/min.
Treatment with a SGLT2-inhibitor, GLP-1-receptor agonist or dipeptidyl-peptidase 4 inhibitor within 30 days before screening or insulin other than basal or premixed within 30 days before screening.
A history of an acute coronary or cerebrovascular event within 90 days before randomization.
Planned revascularization of a coronary, carotid, or peripheral artery.
Inability to give informed consent.
Active cancer diagnosis other than basal cell carcinoma.
Indication of liver disease (serum ALAT, ASAT or alkaline phosphatase above 3 x upper limit).
Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption.
Treatment with systemic steroids at time of randomization.
Change in dosage of thyroid hormones within 6 weeks prior to screening.
Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake.
Chronic or acute pancreatitis.
Pregnancy or breastfeeding.
Allergy to either empagliflozin or semaglutide or any of the excipients contained in the drugs.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified