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Sponsored by: |
Novo Nordisk |
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Information provided by: | Novo Nordisk |
ClinicalTrials.gov Identifier: | NCT00761540 |
This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood concentration of liraglutide (pharmacokinetics) as well as the effects on glucose and insulin (pharmacodynamics) after 21 days of daily subcutaneous injections (injected under the skin) of liraglutide or placebo. In addition, the safety and tolerability of liraglutide will be observed.
Condition | Intervention | Phase |
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Healthy |
Drug: liraglutide Drug: placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Dose Escalation Study to Investigate the Pharmacokinetics, Tolerability and Safety of Liraglutide After Multiple s.c. Doses in Healthy Chinese Male Subjects |
Enrollment: | 37 |
Study Start Date: | October 2008 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A1: Experimental |
Drug: liraglutide
Liraglutide for s.c. injection once daily: dose step 1 (9 subjects)
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A2: Placebo Comparator |
Drug: placebo
Liraglutide placebo for s.c. injection once daily: dose step 1 (3 subjects)
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B1: Experimental |
Drug: liraglutide
Liraglutide for s.c. injection once daily: dose step 1, followed by dose step 2 (9 subjects)
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B2: Placebo Comparator |
Drug: placebo
Liraglutide placebo for s.c. injection once daily: dose step 1, followed by dose step 2 (3 subjects)
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C1: Experimental |
Drug: liraglutide
Liraglutide for s.c. injection once daily: dose step 1, followed by dose steps 2 and 3 (9 subjects)
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C2: Placebo Comparator |
Drug: placebo
Liraglutide placebo for s.c. injection once daily: dose step 1, followed by dose steps 2 and 3 (3 subjects)
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Novo Nordisk A/S ( Public Access to Clinical Trials ) |
Study ID Numbers: | NN2211-3533 |
Study First Received: | September 26, 2008 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00761540 History of Changes |
Health Authority: | China: State Food and Drug Administration |
Healthy Insulin |