Effect of Liraglutide on Epicardial Fat in Subjects With Type 2 Diabetes | RxWiki

Effect of Liraglutide on Epicardial Fat in Subjects With Type 2 Diabetes

Overview[ - collapse ][ - ]

Purpose	The purpose of this research study is to learn about the effect of Liraglutide, (Victoza®), on the fat surrounding the heart.Excessive amount of the fat around the heart is common in people with type 2 diabetes and can be associated with poor sugar control. Liraglutide is an injectable prescription medicine that can improve blood sugar control in adults with type 2 diabetes.
Condition	Type 2 Diabetes Overweight Obesity
Intervention	Drug: Liraglutide Drug: Metformin
Phase	Phase 4
Sponsor	University of Miami
Responsible Party	University of Miami
ClinicalTrials.gov Identifier	NCT02014740
First Received	December 12, 2013
Last Updated	February 7, 2014
Last verified	February 2014

Tracking Information[ + expand ][ + ]

First Received Date	December 12, 2013
Last Updated Date	February 7, 2014
Start Date	March 2014
Estimated Primary Completion Date	September 2015
Current Primary Outcome Measures	Echocardiographic epicardial fat thickness [Time Frame: 6 months] [Designated as safety issue: No]Echocardiographic epicardial fat thickness is an non invasive, inexpensive, reproducible and direct measure of visceral fat. In fact, epicardial fat strongly reflects the intra-abdominal and intra-myocardial fat accumulation as measured by magnetic resonance imaging procedures.
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Effect of Liraglutide on Epicardial Fat in Subjects With Type 2 Diabetes
Official Title	Effect of Liraglutide on Epicardial Fat in Subjects With Type 2 Diabetes
Brief Summary	The purpose of this research study is to learn about the effect of Liraglutide, (Victoza®), on the fat surrounding the heart.Excessive amount of the fat around the heart is common in people with type 2 diabetes and can be associated with poor sugar control. Liraglutide is an injectable prescription medicine that can improve blood sugar control in adults with type 2 diabetes.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Type 2 Diabetes Overweight Obesity
Intervention	Drug: Liraglutide Liraglutide (Victoza) is an acylated analogue of glucagon-like peptide-1 (GLP-1) indicated for the treatment of type 2 diabetes mellitus• L-group will be started and dose-escalated to 1.8mg sc once daily according to below schedule: Liraglutide will be administered with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). L-group subjects will need to achieve the final dose of 1.8 mg by at least three weeks from the starting dose. Subjects who would not be able to achieve the dose of 1.8 mg (due to potential side effects) will be advised to lower the dose to 1.2 mg. Metformin regimen will be continued. . Drug: Metformin
Study Arm (s)	Experimental: Liraglutide • L-group will be started and dose-escalated to 1.8mg sc once daily according to below schedule: Liraglutide will be administered with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). L-group subjects will need to achieve the final dose of 1.8 mg by at least three weeks from the starting dose. Subjects who would not be able to achieve the dose of 1.8 mg (due to potential side effects) will be advised to lower the dose to 1.2 mg. Metformin regimen will be continued. Active Comparator: Metformin M-group will be treated with Metformin for the duration of the study. Metformin (from 500 mg twice daily to a maximum of 1000 mg twice daily) regimen will be continued to achieve fasting glucose between 80 and 140 mg/dl

Recruitment Information[ + expand ][ + ]

Recruitment Status	Not yet recruiting
Estimated Enrollment	100
Estimated Completion Date	September 2015
Estimated Primary Completion Date	December 2014
Eligibility Criteria	Inclusion Criteria: - Type 2 diabetes, as defined by ADA criteria - HbA1c < 8% measured at least 1 month prior to this study - BMI ≥27 kg/m2 - Pre-treatment with Metformin - Age > 18 and < 65 years old Exclusion Criteria: - • Known contra-indications to Liraglutide, such as previous history of pancreatitis or medullary thyroid carcinoma, personal or family history of MEN, in accordance with risks and safety information included in the latest updated Prescribing Information for Victoza® - Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria - Insulin dependent or treated type 2 diabetes - Current use of other injectable incretins - History of diabetes ketoacidosis - Advanced Chronic Kidney Disease, as defined by Glomerular Filtration Rate (GFR) < 30 mL/min/1.73m2 - Clinical signs or symptoms of New York Heart Association (NYHA) class III-IV heart failure - Clinical or laboratory evidences of chronic active liver diseases - Acute or chronic infective diseases - Cancer or chemotherapy - Current use of systemic corticosteroids or in the 3 months prior this study - Known or suspected allergy to Liraglutide, excipients, or related products - Pregnant, breast-feeding or the intention of becoming pregnant - Females of childbearing potential who are not using adequate contraceptive methods
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Gianluca Iacobellis, MD PhD giacobellis@med.miami.edu
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT02014740
Other Study ID Numbers	20120811
Has Data Monitoring Committee	No
Information Provided By	University of Miami
Study Sponsor	University of Miami
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	February 2014

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