Effect of Liraglutide on Heart Frequency in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT01516255

Run by

Novo Nordisk A/S

People needed

64

Starts

2006-07-01

Expected to finish

2006-11-01

Last updated by the study team

2017-01-25

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Novo Nordisk Investigational Site — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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