Safety and Tolerability of Liraglutide in Healthy Male Volunteers
NCT ID: NCT01507272
Last Updated: 2017-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
34 participants
INTERVENTIONAL
1999-03-31
1999-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NNC 90-1170 (liraglutide)
liraglutide
Administered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order
liraglutide
Subjects receiving the dose level 5 mcg/kg s.c. will in addition receive, after a wash-out of at least 7 days, a single i.v. (into the vein) dose of 5 mcg/kg
Placebo
placebo
Administered s.c. After a wash-out of at least 7 days, a single i.v. (into the vein) dose is administered
placebo
Administered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order
Interventions
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liraglutide
Administered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order
liraglutide
Subjects receiving the dose level 5 mcg/kg s.c. will in addition receive, after a wash-out of at least 7 days, a single i.v. (into the vein) dose of 5 mcg/kg
placebo
Administered s.c. After a wash-out of at least 7 days, a single i.v. (into the vein) dose is administered
placebo
Administered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent obtained. (The subject must give signed informed consent before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject)
* Good general health based on medical history, physical and laboratory examinations, incl. ECG (electrocardiogram)
* Body mass index within the range 20-27 kg/m\^2, inclusive
Exclusion Criteria
* History of alcoholism or drug addiction; positive results in the plasma urine screens for illicit drug
* Alcohol intake within 48 hours of visit
* Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies
* History of significant drug allergy or drug hypersensitivity
* Smoke 5 cigarettes or more, or the equivalent per day and is unable to refrain from smoking during the 3 days prior to the dosing day and during the confinement period
* Subjects who drink more than 8 cups of tea/coffee per day
18 Years
45 Years
MALE
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Manchester, , United Kingdom
Countries
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References
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Elbrond B, Jakobsen G, Larsen S, Agerso H, Jensen LB, Rolan P, Sturis J, Hatorp V, Zdravkovic M. Pharmacokinetics, pharmacodynamics, safety, and tolerability of a single-dose of NN2211, a long-acting glucagon-like peptide 1 derivative, in healthy male subjects. Diabetes Care. 2002 Aug;25(8):1398-404. doi: 10.2337/diacare.25.8.1398.
Agerso H, Vicini P. Pharmacodynamics of NN2211, a novel long acting GLP-1 derivative. Eur J Pharm Sci. 2003 Jun;19(2-3):141-50. doi: 10.1016/s0928-0987(03)00073-3.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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NN2211-1149
Identifier Type: -
Identifier Source: org_study_id
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