Effect of Liraglutide on the Metabolic Profile in Patients with Type 2 Diabetes and Cardiovascular Disease

Phase 1

• Conditions: Diabetes Type 2 with existing cardiovascular disease; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-005032-42-DE
• Lead Sponsor: RWTH Aachen University represented by the Rector himself, represented by the Dean of the Medical Faculty

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-10
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Type 2 diabetes
2. Serum levels of HbA1c = 7,0%
3. Age = 18 years
4. Patients with existing cardiovascular disease: coronary heart disease, cerebrovascular disease, peripheral vascular disease or chronic kidney disease of stage III or greater or chronic heart failure of NYHA II or III
5. Written informed consent prior to study participation
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

1.Type 1 diabetes
2.Treatment with GLP-1 receptor agonists or DPP-4 inhibitors within in the last 4 weeks
3.Patients with familiar or personal history of multiple endocrine neoplasia-type 2 or medullary C-cell cancer
4.Renal impairment (eGFR < 30 mL/min)
5.Occurrence of acute vascular events within 6 weeks before screening and randomization
6.Known or suspected hypersensitivity to Liraglutide
7.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.
8.Lactating females
9.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.
10.The subject received an investigational drug within 30 days prior to inclusion into this study.
11.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.
12.The subject is unwilling or unable to follow the procedures outlined in the protocol.
13.The subject is mentally or legally incapacitated.

Study & Design

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