Effect of Liraglutide on Heart Frequency in Healthy Volunteers
NCT ID: NCT01516255
Last Updated: 2017-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
64 participants
INTERVENTIONAL
2006-07-31
2006-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Double-blind / liraglutide
liraglutide
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
placebo
Injected subcutaneously. Subjects are randomly allocated to two treatment sequences
electrocardiogram (ECG)
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 / placebo
liraglutide
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
placebo
Injected subcutaneously. Subjects are randomly allocated to two treatment sequences
electrocardiogram (ECG)
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
Open-label / moxifloxacin
moxifloxacin
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
electrocardiogram (ECG)
Six hours after moxifloxacin or placebo single dose, 1 hour serial ECG is collected
Open-label / placebo
placebo
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
electrocardiogram (ECG)
Six hours after moxifloxacin or placebo single dose, 1 hour serial ECG is collected
Interventions
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liraglutide
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
placebo
Injected subcutaneously. Subjects are randomly allocated to two treatment sequences
moxifloxacin
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
placebo
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
electrocardiogram (ECG)
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
electrocardiogram (ECG)
Six hours after moxifloxacin or placebo single dose, 1 hour serial ECG is collected
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
45 Years
ALL
Yes
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Fargo, North Dakota, United States
Countries
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References
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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.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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NN2211-1644
Identifier Type: -
Identifier Source: org_study_id
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