Effect of Liraglutide on Heart Frequency in Healthy Volunteers

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes; Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01516255

NN2211-1644

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

64 participants in 4 patient groups, including a placebo group

Double-blind / liraglutide

Experimental group

Treatment:

Procedure: electrocardiogram (ECG)

Drug: liraglutide

Drug: placebo

Drug: placebo

Procedure: electrocardiogram (ECG)

Double-blind / placebo

Placebo Comparator group

Treatment:

Procedure: electrocardiogram (ECG)

Drug: liraglutide

Drug: placebo

Drug: placebo

Procedure: electrocardiogram (ECG)

Open-label / moxifloxacin

Active Comparator group

Treatment:

Procedure: electrocardiogram (ECG)

Drug: moxifloxacin

Procedure: electrocardiogram (ECG)

Open-label / placebo

Placebo Comparator group

Treatment:

Procedure: electrocardiogram (ECG)

Drug: placebo

Drug: placebo

Procedure: electrocardiogram (ECG)