NCT01620476

Brief Summary

This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of liraglutide in healthy Japanese male subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 diabetes

Timeline
Completed

Started Sep 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

June 13, 2012

Last Update Submit

January 24, 2017

Conditions

DiabetesHealthy

Outcome Measures

Primary Outcomes (1)

  • Area under the plasma liraglutide curve

Secondary Outcomes (8)

  • Cmax, maximum plasma liraglutide concentration

  • tmax, time to reach Cmax

  • Terminal phase elimination rate-constant

  • t½, terminal elimination half life

  • 24-hour profiles of serum insulin

  • +3 more secondary outcomes

Study Arms (3)

5 mcg/kg

EXPERIMENTAL
Drug: liraglutideDrug: placebo

10 mcg/kg

EXPERIMENTAL
Drug: liraglutideDrug: placebo

15 mcg/kg

EXPERIMENTAL
Drug: liraglutideDrug: placebo

Interventions

liraglutideDRUG

5 mcg/kg for 21 days. Injected subcutaneously once daily. Progression to the next dose level based on safety data

5 mcg/kg
placeboDRUG

Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1

10 mcg/kg15 mcg/kg5 mcg/kg

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Japanese
  • Body mass index (BMI) between 18 and 27 kg/m\^2 inclusive

You may not qualify if:

  • Any clinical laboratory values deviated from the reference range at the laboratory
  • 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
  • Smokes more than 15 cigarettes, or the equivalent, per day andis unwilling to refrain from smoking whenever required for the trial procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Location

Related Publications (1)

  • Kageyama S, Hirao K, Shimizu A, Matsumura Y, Zdravkovic M, Rasmussen MF, Irie S. Tolerability, pharmacokinetics, and pharmacodynamics of liraglutide, long-acting human GLP-1 analogue - Phase 1 studies in Japanese healthy subjects with type 2 diabetes. Endocrinology and Diabetology 2007; 24 (6): 95-104

    RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2012

First Posted

June 15, 2012

Study Start

September 1, 2003

Primary Completion

March 1, 2004

Study Completion

March 1, 2004

Last Updated

January 25, 2017

Record last verified: 2017-01

Locations

JP(1)