NCT01515553

Brief Summary

This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of the phase 3a formulation of liraglutide (formulation 4) and the liraglutide formulation planned for phase 3b trials (final formulation 4).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_1 diabetes

Timeline
Completed

Started Jan 2007

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

Study Start

First participant enrolled

January 1, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
Last Updated

January 13, 2015

Status Verified

January 1, 2015

Enrollment Period

3 months

First QC Date

January 18, 2012

Last Update Submit

January 12, 2015

Conditions

DiabetesHealthy

Outcome Measures

Primary Outcomes (2)

  • Area under the curve (0-t)

  • Cmax, maximum concentration

Secondary Outcomes (6)

  • Area under the curve (0-infinity)

  • Relative bioavailability

  • Time to reach maximum (tmax)

  • Terminal elimination half life (t½)

  • Terminal elimination rate constant

  • +1 more secondary outcomes

Study Arms (2)

Formulation 4

EXPERIMENTAL
Drug: liraglutide

Final formulation 4

EXPERIMENTAL
Drug: liraglutide

Interventions

liraglutideDRUG

Two single doses of 0.72 mg liraglutide administered subcutaneously on two different dosing occasions separated by a wash-out period

Final formulation 4Formulation 4

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments
  • BMI (Body Mass Index) of 18.0-27.0 kg/m\^2, both inclusive

You may not qualify if:

  • History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the Investigator
  • Impaired renal function
  • Any clinically significant abnormal ECG, as judged by the Investigator
  • Active hepatitis B and/or active hepatitis C
  • Positive human immunodeficiency virus (HIV) antibodies
  • Known or suspected allergy to trial product(s) or related products
  • Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
  • History of alcoholism or drug abuse, or positive results in alcohol or drug screens
  • Smoking of more than 5 cigarettes per day, or the equivalent for other tobacco products
  • Habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the Investigator
  • Excessive consumption of a diet deviating from a normal diet as judged by the Investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Lund, 221 85, Sweden

Location

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
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 18, 2012

First Posted

January 24, 2012

Study Start

January 1, 2007

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

January 13, 2015

Record last verified: 2015-01

Locations

SE(1)