Diabetes, Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGliraglutide
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
DRUGplacebo
Injected subcutaneously. Subjects are randomly allocated to two treatment sequences
DRUGmoxifloxacin
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
PROCEDUREelectrocardiogram (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
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum time-matched mean difference between the baseline subtracted QTci intervals | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
| QTc at liraglutide tmax (time to reach maximum concentration) | — |
| Vitals signs: Blood pressure | — |
| Vital signs: Pulse | — |
| Serial electrocardiography | — |
| tmax, time to reach Cmax of liraglutide | — |
Countries
United States
Outcome results
None listed