Back to resultsSafety and Tolerability of Liraglutide in Healthy Japanese Male Volunteers
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
liraglutide
liraglutide
liraglutide
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Healthy Japanese subjects
- BMI (Body Mass Index) between 18.0-27.0 kg/m^2 inclusive
Exclusion Criteria:
- Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal ECG (electrocardiogram) findings at the screening
- Presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
- Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
- History of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
- History of significant allergy or hypersensitivity
- Known or suspected allergy to trial product or related products
- History of drug or alcohol abuse
- The subjects who smoke more than 15 cigarettes, or the equivalent, per day and is unwilling to refrain from smoking whenever required for the trial procedure
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
15 mcg/kg
20 mcg/kg
25 mcg/kg
Arm Description
Outcomes
Primary Outcome Measures
Adverse events
Body weight
Antibody against liraglutide
Secondary Outcome Measures
Area under the plasma liraglutide concentration curve
Cmax, maximum concentration
tmax, time to reach Cmax
Terminal elimination rate constant
t½, terminal elimination half-life
24-hour profiles of plasma glucose
24-hour profiles of serum insulin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01515592
Brief Title
Safety and Tolerability of Liraglutide in Healthy Japanese Male Volunteers
Official Title
A Randomised, Double-blind Within Dose Group, Single Centre, Placebo-controlled, Dose Escalation, Multiple s.c. Dose Study to Assess the Safety and Tolerability of Liraglutide 20 ug/kg and 25 ug/kg in Healthy Japanese Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of 20 µg/kg and 25 µg/kg liraglutide in healthy Japanese male subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
15 mcg/kg
Arm Type
Experimental
Arm Title
20 mcg/kg
Arm Type
Experimental
Arm Title
25 mcg/kg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
One daily subcutaneous dose for 5 weeks. Dose is weekly incremented with 5 mcg/kg
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
One daily subcutaneous dose for 5 weeks. 5 mcg/kg the first week, then 10 mcg the second week followed by 15 mcg the third week, and finally 20 mcg for 2 weeks
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
One daily subcutaneous dose for 5 weeks. 5 mcg/kg the first week, then 10 mcg the second week followed by 15 mcg for 3 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1
Primary Outcome Measure Information:
Title
Adverse events
Title
Body weight
Title
Antibody against liraglutide
Secondary Outcome Measure Information:
Title
Area under the plasma liraglutide concentration curve
Title
Cmax, maximum concentration
Title
tmax, time to reach Cmax
Title
Terminal elimination rate constant
Title
t½, terminal elimination half-life
Title
24-hour profiles of plasma glucose
Title
24-hour profiles of serum insulin
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Healthy Japanese subjects
BMI (Body Mass Index) between 18.0-27.0 kg/m^2 inclusive
Exclusion Criteria:
Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal ECG (electrocardiogram) findings at the screening
Presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
History of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
History of significant allergy or hypersensitivity
Known or suspected allergy to trial product or related products
History of drug or alcohol abuse
The subjects who smoke more than 15 cigarettes, or the equivalent, per day and is unwilling to refrain from smoking whenever required for the trial procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
1000005
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
18541123
Citation
Irie S, Matsumura Y, Zdravkovic M, Jacobsen LV, Kageyama S. Tolerability, pharmacokinetics and pharmacodynamics of the once-daily human GLP-1 analog liraglutide in Japanese healthy subjects: a randomized, double-blind, placebo-controlled dose-escalation study. Int J Clin Pharmacol Ther. 2008 Jun;46(6):273-9. doi: 10.5414/cpp46273.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
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Safety and Tolerability of Liraglutide in Healthy Japanese Male Volunteers
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