Effect of Liraglutide on Heart Frequency in Healthy Volunteers

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Drug: liraglutide; Drug: moxifloxacin; Drug: placebo; Procedure: electrocardiogram (ECG)

• Registration Number: NCT01516255
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Study First Submitted: 2012-01-19
• Study First Submitted QC: 2012-01-19
• Study First Posted: 2012-01-24
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Double-blind / liraglutide	electrocardiogram (ECG)	-
Double-blind / placebo	placebo	-
Double-blind / placebo	liraglutide	-
Double-blind / liraglutide	placebo	-
Open-label / placebo	placebo	-
Open-label / placebo	electrocardiogram (ECG)	-
Double-blind / placebo	electrocardiogram (ECG)	-
Open-label / moxifloxacin	electrocardiogram (ECG)	-
Double-blind / liraglutide	liraglutide	-
Open-label / moxifloxacin	moxifloxacin	-

Primary Outcome Measures

Name	Time	Method
Maximum time-matched mean difference between the baseline subtracted QTci intervals

Secondary Outcome Measures

Name	Time	Method
QTc at liraglutide tmax (time to reach maximum concentration)
Percentage subjects with QTc at least 450, 480 and 500 milliseconds
Cmax, maximum concentration of liraglutide
Vitals signs: Blood pressure
Serial electrocardiography
tmax, time to reach Cmax of liraglutide
Moxifloxacin maximum time-matched mean change QTc and QTci
Vital signs: Pulse

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Fargo, North Dakota, United States