NCT00761540

Brief Summary

This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood concentration of liraglutide (pharmacokinetics) as well as the effects on glucose and insulin (pharmacodynamics) after 21 days of daily subcutaneous injections (injected under the skin) of liraglutide or placebo. In addition, the safety and tolerability of liraglutide will be observed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P50-P75 for phase_1 diabetes

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_1 diabetes

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

First Submitted

Initial submission to the registry

September 26, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2008

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

2 months

First QC Date

September 26, 2008

Last Update Submit

January 25, 2017

Conditions

DiabetesHealthy

Outcome Measures

Primary Outcomes (1)

  • AUC 0-24h (last dosing day): Area under the plasma liraglutide curve from 0 to 24 hours after last dosing.

    After 21 days of treatment

Secondary Outcomes (3)

  • AUC 0-24h: Area under the plasma liraglutide curve from 0 to 24 hours after first dosing, AUC0-24h (Day 1)

    After 1 day of treatment

  • Adverse events

    After 21 days of treatment

  • Hypoglycaemic events

    After 21 days of treatment

Study Arms (6)

A1

EXPERIMENTAL
Drug: liraglutide

A2

PLACEBO COMPARATOR
Drug: placebo

B1

EXPERIMENTAL
Drug: liraglutide

B2

PLACEBO COMPARATOR
Drug: placebo

C1

EXPERIMENTAL
Drug: liraglutide

C2

PLACEBO COMPARATOR
Drug: placebo

Interventions

liraglutideDRUG

Liraglutide for s.c. injection once daily: dose step 1 (9 subjects)

A1
placeboDRUG

Liraglutide placebo for s.c. injection once daily: dose step 1 (3 subjects)

A2

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Informed consent obtained before any trial related activities
  • Healthy Chinese male subjects
  • Body mass index (BMI) between 19.0 and 27.0 kg/m2 (both inclusive)
  • Fasting plasma glucose less than 6.0 mmol/L
  • Non-smoker

You may not qualify if:

  • Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening (any abnormality should be discussed with the clinical monitor)
  • Presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
  • Blood pressure in supine position at the screening, after resting for 5 min, outside the ranges 90- 140 mmHg systolic and/or 40 - 90 mmHg diastolic
  • Pulse in supine position at the screening, after resting for 5 min, outside the range 40 - 100 times/min
  • Hepatitis B surface antigen, Hepatitis C antibodies or HIV antibodies positive.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, 100032, China

Location

Related Publications (1)

  • Jiang J, Zhang J, Jacobsen LV, Hu P. The pharmacokinetics, pharmacodynamics, and tolerability of liraglutide, a once-daily human GLP-1 analogue, after multiple subcutaneous administration in healthy Chinese male subjects. J Clin Pharmacol. 2011 Dec;51(12):1620-7. doi: 10.1177/0091270010389468. Epub 2011 Jan 27.

    PMID: 21273395RESULT

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

September 26, 2008

First Posted

September 29, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

January 26, 2017

Record last verified: 2017-01

Locations

CN(1)