Status:
WITHDRAWN
Effect of Liraglutide on the Metabolic Profile in Patients With Type 2 Diabetes and Cardiovascular Disease
Lead Sponsor:
RWTH Aachen University
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Type 2 Diabetes
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
In an unbiased metabolomics approach with subsequent pathway analyses, the current study seeks to examine the effect of Liraglutide treatment on the metabolic signature in treated patients as well as ...
Eligibility Criteria
Inclusion
- Type 2 diabetes
- Serum levels of HbA1c ≥ 7,0%
- Age ≥ 18 years
- Patients with existing cardiovascular disease: coronary heart disease, cerebrovascular disease, peripheral vascular disease, chronic kidney disease of stage III or chronic heart failure of NYHA II or III)
- Written informed consent prior to study participation
Exclusion
- Type 1 diabetes
- Treatment with GLP-1 receptor agonists or DPP-4 inhibitors within the last 4 weeks
- Patients with familiar or personal history of multiple endocrine neoplasia-type 2 or medullary C-cell cancer
- Renal impairment (eGFR \< 30 mL/min)
- Occurrence of acute vascular events within 6 weeks before screening and randomization
- Known or suspected hypersensitivity to Liraglutide
- Pregnant females as determined by positive (serum or urine) hCG test at Screening or prior to dosing. Participants of child-bearing age should use adequate contraception as defined in the study protocol.
- Lactating females
- The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication.
- The subject received an investigational drug within 30 days prior to inclusion into this study.
- The subject has any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study.
- The subject is unwilling or unable to follow the procedures outlined in the protocol.
- The subject is mentally or legally incapacitated.
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04057261
Start Date
November 1 2020
End Date
November 1 2022
Last Update
March 10 2021
Active Locations (1)
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1
Department of Internal Medicine I, University Hospital
Aachen, Germany, 52074