Effect of Liraglutide on Heart Frequency in Healthy Volunteers

NCT01516255 | Completed Phase 1

• 1 other identifier: NN2211-1644
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (8)

• 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

Study Arms (4)

Double-blind / liraglutide

EXPERIMENTAL

Drug: liraglutide; Drug: placebo; Procedure: electrocardiogram (ECG)

Double-blind / placebo

PLACEBO COMPARATOR

Drug: liraglutide; Drug: placebo; Procedure: electrocardiogram (ECG)

Open-label / moxifloxacin

ACTIVE COMPARATOR

Drug: moxifloxacin; Procedure: electrocardiogram (ECG)

Open-label / placebo

PLACEBO COMPARATOR

Drug: placebo; Procedure: electrocardiogram (ECG)

Interventions

liraglutide DRUG

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

Double-blind / liraglutide; Double-blind / placebo

placebo DRUG

Injected subcutaneously. Subjects are randomly allocated to two treatment sequences

Double-blind / liraglutide; Double-blind / placebo

moxifloxacin DRUG

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

Open-label / moxifloxacin

electrocardiogram (ECG) PROCEDURE

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

Double-blind / liraglutide; Double-blind / placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Fargo, North Dakota, 58104, United States

Location

Related Publications (1)

• 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.

  PMID: 19737980 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Liraglutide; Moxifloxacin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: January 24, 2012
• Study Start: July 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: January 25, 2017

Record last verified: 2017-01

Locations

US (1)