Effect of Liraglutide on the Metabolic Profile in Patients With Type 2 Diabetes and Cardiovascular Disease (Lirabolic)

RWTH Aachen University

Status and phase: Withdrawn; Phase 3

Conditions: Cardiovascular Diseases; Type 2 Diabetes

Treatments: Drug: Placebo; Drug: Liraglutide Pen Injector [Victoza]

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04057261

17-162

Details and patient eligibility

About

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 the effect of Liraglutide on various echocardiographic parameters of cardiac function and rhythm profile, thus paving the way for future research to explain the effects of Liraglutide on cardiovascular mortality and overall mortality in treated patients.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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, chronic kidney disease of stage III or chronic heart failure of NYHA II or III)
5. Written informed consent prior to study participation

Exclusion criteria

1. Type 1 diabetes
2. Treatment with GLP-1 receptor agonists or DPP-4 inhibitors within 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

0 participants in 2 patient groups, including a placebo group

Liraglutide

Active Comparator group

Description:

Increasing dose of Liraglutide: 0.6 mg/d for the first week, 1.2 mg/d for the second week aiming for a maximum of 1.8 mg/d beginning with the third week (or highest tolerated dose).Subcutaneous injection once daily via pre-filled pen.

Treatment:

Drug: Liraglutide Pen Injector [Victoza]

Placebo

Placebo Comparator group

Description:

Matching Placebo once daily, subcutaneous injection via pre-filled pen.

Treatment:

Drug: Placebo