Clinical trial NCT01516255: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-24
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Maximum time-matched mean difference between the baseline subtracted QTci intervals
Secondary outcomes:
measure: QTc at liraglutide tmax (time to reach maximum concentration)
measure: Percentage subjects with QTc at least 450, 480 and 500 milliseconds
measure: Moxifloxacin maximum time-matched mean change QTc and QTci
measure: Cmax, maximum concentration of liraglutide
measure: tmax, time to reach Cmax of liraglutide
measure: Vitals signs: Blood pressure
measure: Vital signs: Pulse
measure: Serial electrocardiography
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Novo Nordisk Investigational Site
state: North Dakota
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
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.