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

NCT ID: NCT04057261

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2022-11-30

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 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.

Conditions

Type 2 Diabetes; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Liraglutide

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.

Group Type: ACTIVE_COMPARATOR

Liraglutide Pen Injector [Victoza]

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Liraglutide Pen Injector [Victoza]

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Internal Medicine I, University Hospital

Aachen, , Germany

Countries

Germany

Other Identifiers

17-162

Identifier Type: -

Identifier Source: org_study_id