Skip to content

Trial · Interventional

CompletedPhase 4Registry data

Effect of Liraglutide on Diastolic Dysfunction on Cardiac MRI in Type 2 Diabetes Patients

NCTNCT02655770 (opens ClinicalTrials.gov in a new tab)Other id2015-000410-22Other id2015-000410-22Other id2015

Overview

Status
Completed
Phase
Phase 4
Enrollment
40 participants (actual)
Sponsor
Copenhagen University Hospital, Rigshospitalet · Other
Design
Randomized · Triple masking
Countries
1 country

Denmark

Start
Feb 2016
Primary completion
Dec 2019
Completion
Dec 2019
First posted
14 Jan 2016 (estimated)
Last update posted
14 Jan 2021
Conditions
Diabetes Mellitus Type 2 · Diastolic Dysfunction · Cardiac MRI · Myocardial Perfusion

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20162017201820192020
  1. Ph 4

    Effect of Liraglutide on Diastolic Dysfunction on Cardiac MRI in Type 2 Diabetes Patients

    NCT02655770

    Feb 2016 to Dec 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to determine whether liraglutide a GLP-1 analogue are effective in the treatment of diastolic dysfunction in type 2 diabetes patients analyzed by cardiac MRI. Secondary if the treatment has any effect on the perfusion of the heart on a cardiac-MRI.

Interventions

  • LiraglutideDrug
  • PlaceboDrug

Arms2

  • Active comparator

    Liraglutide arm

    Patients will be treated with liraglutide (up to 1.8 mg s.c. once daily). Total treatment period will be 18 weeks.

  • Placebo comparator

    Placebo arm

    Patients will be treated with placebo (up to equal to 1.8 mg drug dose s.c. once daily). Total treatment period will be 18 weeks. The study will be placebo-controlled with placebo as an add-on to conventional diabetes treatment. Thus, no patient will receive a sub-standard treatment.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change in diastolic properties as assessed by CMR.

    Time frame · Measured in week 18 and compared to baseline.

    Registry description

    LA passive emptying fraction (%) (before and after glycopyrolate)

  2. Change in diastolic properties as assessed by CMR.

    Time frame · Measured in week 18 and compared to baseline.

    Registry description

    LV peak filling rate (ml/s) (before and after glycopyrolate)

Secondary outcomes(2)
  1. MRI indices of myocardial perfusion

    Time frame · Measured in week 18 and compared to baseline.

  2. Echocardiographic indices of diastolic dysfunction

    Time frame · Measured in week 18 and compared to baseline.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2012

8 results

Effects of intravenous exenatide in type 2 diabetic patients with congestive heart failure: a double-blind, randomised controlled clinical trial of efficacy and safety.

Nathanson et al. 2012Diabetologiacited by 84

PMID 22246377DOI 10.1007/s00125-011-2440-xPUB-22246377

Full text at the publisher8 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female patient fully capable of informed consent * Informed consent * Age 18-80 years (both years inclusive) * T2DM diagnosed at least 3 months prior to visit 0 * NYHA class I-III at visit 0 * E/e\* ≥ 9 or e\* (lateral) ≤10 cm/sec, or both * LVEF \> 50% * LVEDV/BSA \< 97 ml/m2 * Stable on heart medication for 6 weeks prior to randomisation * Stable on antidiabetic treatment for 30 days prior to randomisation * T2DM must be either treated with one or more oral anti-diabetic drugs or treated with human NPH-insulin or long-acting insulin analogue, alone or in combination with oral drugs Exclusion Criteria: * Lack of consent. * NYHA class IV * Type 1 diabetes mellitus * Incretin-based therapy (GLP-1 receptor agonists; exenatide, liraglutide or other and DPP-IV inhibitors) within 30 days prior to randomisation (visit 1) * Glitazon therapy within 30 days prior to randomisation (visit 1) * Hypertension with inadequate blood pressure control: Systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \>85 mmHg\* * Supine systolic blood pressure \<85 mmHg measured at visit 0 * Significant valvular heart disease * Hypertrophic cardiomyopathy, ARVC/D, non-compaction or amyloidosis * Myocardial infarction, unstable angina, angina on exertion (≥CCS class 2) or coronary revascularization within 3 months prior to randomisation (visit 1) * Hospitalisation due to incompensated heart disease within 30 days to randomisation (visit 1) * HbA1c \>10% at visit 0 * eGFR\< 60 ml/min/1,73 m2 at visit 0 * Liver disease with aspartate aminotransferase/alanine aminotransferase \>3 times upper limit of normal measured at visit 0\*\* * Hypokalaemia (P-potassium \<3.5 mmol/L) or hyperkalaemia (P-potassium \>5.5 mmol/L) measured at visit 0\*\* * Anaemia (haemoglobin \<6.5 mmol/L) measured at visit 0\*\* * Conditions that may be associated with changes in markers of fibroses or collagen turnover (eg. on-going or active rheumatological disease requiring anti-inflammatory agents, immunosuppression, pulmonary fibrosis, active cancer) * Prolonged use (\> 2 weeks) of glucocorticoids or NSAIDs within 2 weeks prior to visit 0 * Women of childbearing potential who are not on acceptable contraception. See below. * Pregnant or breastfeeding women * Cancer (except basal cell skin cancer or squamous cell skin cancer) unless complete remission for ≥ 5 years * Alcohol/drug abuse * Chronic or previous acute pancreatitis * History of thyroid adenoma or carcinoma * Inflammatory bowel disease * Clinical signs of diabetic gastroparesis * ICD/pacemaker or other contraindications to MRI scan * Severe claustrophobia * Atrial fibrillation * Contraindications to glycopyrrolate: closed-angle glaucoma, prostate hyperplasia, tachycardia, bladder atony, cardia insufficiency, non-congenital pylorus stenosis and gastroparesis * Known or suspected hypersensitivity to trial product or related products * Current participation in any other clinical intervention trial * Receipt of an investigational drug with 30 days prior to visit 0 * Other concominant disease or treatment that according to investigator's assessment makes the patient unsuitable for participation in the study * Measured twice at visit 0. In case of elevation, an ambulatory (24-hour) blood pressure will be performed, and the result of this will be conclusive * Measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value will be conclusive.

PepBank is a research reference. Talk to a doctor before you use any peptide.