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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-blind / liraglutide | Experimental |
| |
| Double-blind / placebo | Placebo Comparator |
| |
| Open-label / moxifloxacin | Active Comparator |
| |
| Open-label / placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum time-matched mean difference between the baseline subtracted QTci intervals |
| Measure | Description | Time Frame |
|---|---|---|
| QTc at liraglutide tmax (time to reach maximum concentration) | ||
| Percentage subjects with QTc at least 450, 480 and 500 milliseconds | ||
| Moxifloxacin maximum time-matched mean change QTc and QTci |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Fargo | North Dakota | 58104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19737980 | Result | 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. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| 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 |
|
| Cmax, maximum concentration of liraglutide |
| tmax, time to reach Cmax of liraglutide |
| Vitals signs: Blood pressure |
| Vital signs: Pulse |
| Serial electrocardiography |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |