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Trial · Interventional

CompletedPhase 1Registry data

Effect of Liraglutide on Heart Frequency in Healthy Volunteers

Overview

Status
Completed
Phase
Phase 1
Enrollment
64 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
Jul 2006
Primary completion
Nov 2006
Completion
Nov 2006
First posted
24 Jan 2012 (estimated)
Last update posted
25 Jan 2017 (estimated)
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20062007
  1. Ph 1

    Effect of Liraglutide on Heart Frequency in Healthy Volunteers

    NCT01516255

    Jul 2006 to Nov 2006

Registry summary

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

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate if liraglutide effects the QTc interval. Moxifloxacin (Avelox®) is administered as positive control.

Interventions

  • liraglutideDrug
  • placeboDrug
  • moxifloxacinDrug
  • placeboDrug
  • electrocardiogram (ECG)Procedure
  • electrocardiogram (ECG)Procedure

Arms4

  • Experimental

    Double-blind / liraglutide

  • Placebo comparator

    Double-blind / placebo

  • Active comparator

    Open-label / moxifloxacin

  • Placebo comparator

    Open-label / placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Maximum time-matched mean difference between the baseline subtracted QTci intervals

Secondary outcomes(8)
  1. QTc at liraglutide tmax (time to reach maximum concentration)

  2. Percentage subjects with QTc at least 450, 480 and 500 milliseconds

  3. Moxifloxacin maximum time-matched mean change QTc and QTci

  4. Cmax, maximum concentration of liraglutide

  5. tmax, time to reach Cmax of liraglutide

  6. Vitals signs: Blood pressure

  7. Vital signs: Pulse

  8. Serial electrocardiography

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 · 2009

3 results

Absence of QTc prolongation in a thorough QT study with subcutaneous liraglutide, a once-daily human GLP-1 analog for treatment of type 2 diabetes.

Chatterjee et al. 2009Journal of clinical pharmacologycited by 42

PMID 19737980DOI 10.1177/0091270009339189PUB-19737980

Full text at the publisher3 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Healthy * Fasting plasma glucose within normal limits (80-100 mg/dl) * BMI (Body Mass Index): 20.0-29.0 kg/m\^2 (inclusive) * Heart rate within the range of 50-90 beats per minute (inclusive) * Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data Exclusion Criteria: * Any clinically significant disease history, in the opinion of the investigator, of systemic or organ disease * Any clinically significant disease history, in the opinion of the investigator, of cardiovascular disease * Clinically significant abnormalities on any pre-study clinical examination or any abnormal laboratory measurements during screening * A family history of sudden cardiac death at age less than 50 years old * T-wave abnormalities * Individual or familial history of long QT Syndrome * Positive results on Screening for Hepatitis B surface antigen, Hepatitis C antibody or HIV (human immunodeficiency virus) antibody * Positive results on the urine drug and alcohol screen * Any regular use of prescription or nonprescription drugs or vitamins and herbal/nutritional supplements that cannot be stopped at screening * Any strenuous exercise (as judged by the investigator) from 4 days prior to randomisation and during the entire trial period * Blood donation, trauma or surgery with blood loss exceeding 500 ml within the last 2 months prior to dosing * Subject is a smoker, occasional smoker or has a history of smoking (or use of any tobacco) within the last 3 months * Excessive use of methylxanthine-containing beverages (more than 8 cups/day of coffee, tea, soda or chocolate) * Females who are pregnant, breastfeeding, intend to become pregnant within the next 3 months, or who are judged to be using inadequate contraceptive measures * A history (within the last 2 years) of drug or alcohol abuse

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