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Trial · Interventional

CompletedPhase 1Registry data

Safety and Tolerability of Liraglutide in Healthy Japanese Male Volunteers

NCTNCT01515592 (opens ClinicalTrials.gov in a new tab)Other idNN2211-1694
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
24 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
1 country

Japan

Start
Jan 2006
Primary completion
Apr 2006
Completion
Apr 2006
First posted
24 Jan 2012 (estimated)
Last update posted
25 Jan 2017 (estimated)
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20062007
  1. Ph 1

    Safety and Tolerability of Liraglutide in Healthy Japanese Male Volunteers

    NCT01515592

    Jan 2006 to Apr 2006

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • liraglutideDrug
  • liraglutideDrug
  • liraglutideDrug
  • placeboDrug

Arms3

  • Experimental

    15 mcg/kg

  • Experimental

    20 mcg/kg

  • Experimental

    25 mcg/kg

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Adverse events

  2. Body weight

  3. Antibody against liraglutide

Secondary outcomes(7)

  1. Area under the plasma liraglutide concentration curve

  2. Cmax, maximum concentration

  3. tmax, time to reach Cmax

  4. Terminal elimination rate constant

  5. t½, terminal elimination half-life

  6. 24-hour profiles of plasma glucose

  7. 24-hour profiles of serum insulin

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2008

12 results

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.

Irie et al. 2008International journal of clinical pharmacology and therapeuticscited by 31

PMID 18541123DOI 10.5414/cpp46273PUB-18541123

Full text at the publisher12 results
Publisher pageSee results (12)

Eligibility

Who could join, as posted.

Sex
Male
Age
from 20 Years up to 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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