Safety and Tolerability of Liraglutide in Healthy Japanese Male Volunteers

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515592
• Other study ID #: NN2211-1694
• Status: Completed
• Phase: Phase 1
• First received: January 18, 2012
• Last updated: January 24, 2017
• Start date: January 2006
• Est. completion date: April 2006

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide
One daily subcutaneous dose for 5 weeks. Dose is weekly incremented with 5 mcg/kg
• liraglutide
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
• liraglutide
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
• placebo
Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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 s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events
Primary	Body weight
Primary	Antibody against liraglutide
Secondary	Area under the plasma liraglutide concentration curve
Secondary	Cmax, maximum concentration
Secondary	tmax, time to reach Cmax
Secondary	Terminal elimination rate constant
Secondary	t½, terminal elimination half-life
Secondary	24-hour profiles of plasma glucose
Secondary	24-hour profiles of serum insulin

External Links

•   Clinical Trials at Novo Nordisk