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

NCT04057261 | Withdrawn Phase 3

• 1 other identifier: 17-162
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Liraglutide; Type 2 Diabetes; High Cardiovascular Risk; Myocardial Infarction; Metabolic Profile

Outcome Measures

Primary Outcomes (1)

• Changes in the metabolomics profile (fold changes) between Liraglutide treatment group and placebo group after 1 and 3 months

  Changes in the metabolomics profile (fold changes) between Liraglutide treatment group and placebo group after 1 and 3 months measured by a platform including 2 separate reverse phase (RP)/UPLC-MS/MS with positive ion mode electrospray ionization (ESI), (RP)/UPLC-MS/MS with negative ESI, and (HILIC)/UPLC-MS/MS with negative ESI.

  3 month

Secondary Outcomes (15)

• change in left ventricular diastolic function

  3 month

• change in left ventricular diastolic function

  3 month

• change in left ventricular systolic function

  3 month

• Changes in systolic and diastolic blood pressure (mmHg)

  3 month

• body weight

  3 month

Study Arms (2)

Liraglutide

ACTIVE COMPARATOR

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.

Drug: Liraglutide Pen Injector [Victoza]

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Liraglutide Pen Injector [Victoza] 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

Liraglutide

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• RWTH Aachen University: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Department of Internal Medicine I, University Hospital

Aachen, 52074, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases; Myocardial Infarction

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single center, prospective, placebo-controlled, double-blind, randomized, 2 arm parallel, interventional, exploratory pilot study

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: August 15, 2019
• Study Start: November 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: November 1, 2022
• Last Updated: March 10, 2021

Record last verified: 2021-03

Locations

DE (1)