Back to results

Effect of Liraglutide on Heart Frequency in Healthy Volunteers

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

liraglutide

placebo

moxifloxacin

placebo

electrocardiogram (ECG)

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Double-blind / liraglutide

Double-blind / placebo

Open-label / moxifloxacin

Open-label / placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

QTc at liraglutide tmax (time to reach maximum concentration)

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

Moxifloxacin maximum time-matched mean change QTc and QTci

Cmax, maximum concentration of liraglutide

tmax, time to reach Cmax of liraglutide

Vitals signs: Blood pressure

Vital signs: Pulse

Serial electrocardiography

Full Information

NCT ID

NCT01516255

First Posted

January 19, 2012

Last Updated

January 24, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01516255

Brief Title

Effect of Liraglutide on Heart Frequency in Healthy Volunteers

Official Title

A Thorough QTc Evaluation of the Effect of Liraglutide on Cardiac Repolarization in Healthy Volunteers: A Randomized, Double-blind, Placebo-controlled, Two Period Crossover Study Followed by Open-label Moxifloxacin (Positive Control) Administration

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

November 2006 (Actual)

Study Completion Date

November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Double-blind / liraglutide

Arm Type

Experimental

Arm Title

Double-blind / placebo

Arm Type

Placebo Comparator

Arm Title

Open-label / moxifloxacin

Arm Type

Active Comparator

Arm Title

Open-label / placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

liraglutide

Intervention Description

0.6 mg daily for 7 days followed by 1.2 mg daily for 7 days followed by 1.8 mg daily for 7 days. Injected subcutaneously. Subjects are randomly allocated to two treatment sequences

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Injected subcutaneously. Subjects are randomly allocated to two treatment sequences

Intervention Type

Drug

Intervention Name(s)

moxifloxacin

Intervention Description

Following the double-blinded period and a wash-out period of 7 days, subjects are re-randomised to an open-label, parallel period where a single dose of 400 mg moxifloxacin (tablets) is administered as positive control

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Following the double-blinded period and a wash-out period of 7 days, subjects are re-randomised to an open-label, parallel period where single dose of oral placebo is administered

Intervention Type

Procedure

Intervention Name(s)

electrocardiogram (ECG)

Intervention Description

24 hours serial ECG is collected before initial dose of 0.6 mg liraglutide, on the last dosing day of 1.2 mg liraglutide and on the last dosing day of 1.8 mg liraglutide

Intervention Type

Procedure

Intervention Name(s)

electrocardiogram (ECG)

Intervention Description

Six hours after moxifloxacin or placebo single dose, 1 hour serial ECG is collected

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

QTc at liraglutide tmax (time to reach maximum concentration)

Title

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

Title

Moxifloxacin maximum time-matched mean change QTc and QTci

Title

Cmax, maximum concentration of liraglutide

Title

tmax, time to reach Cmax of liraglutide

Title

Vitals signs: Blood pressure

Title

Vital signs: Pulse

Title

Serial electrocardiography

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58104

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19737980

Citation

Chatterjee DJ, Khutoryansky N, Zdravkovic M, Sprenger CR, Litwin JS. 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. J Clin Pharmacol. 2009 Nov;49(11):1353-62. doi: 10.1177/0091270009339189. Epub 2009 Sep 8.

Results Reference

result

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

Effect of Liraglutide on Heart Frequency in Healthy Volunteers

We'll reach out to this number within 24 hrs