Effect of Liraglutide on Heart Frequency in Healthy Volunteers

Part of paid clinical trials in Fargo, North Dakota.

Sponsor: Novo Nordisk A/S
Study ID: NCT01516255
Phase: PHASE1
Status: Completed

Conditions

Diabetes
Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: ALL
Age: 18 Years - 45 Years
Healthy Volunteers: Accepted

Interventions

liraglutide — DRUG
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 — DRUG
Injected subcutaneously. Subjects are randomly allocated to two treatment sequences
moxifloxacin — DRUG
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 — DRUG
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) — PROCEDURE
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) — PROCEDURE
Six hours after moxifloxacin or placebo single dose, 1 hour serial ECG is collected

Study Details

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.