NCT01507272

Brief Summary

This trial is conducted in Europe. The aim of this trial is to assess the safety and tolerability (maximum tolerated dose) after five ascending single doses of NNC 90-1170 (liraglutide).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for phase_1 diabetes

Timeline
Completed

Started Mar 1999

Typical duration 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

March 1, 1999

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1999

Completed
12.1 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 10, 2012

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

9 months

First QC Date

January 5, 2012

Last Update Submit

January 23, 2017

Conditions

DiabetesHealthy

Outcome Measures

Primary Outcomes (1)

  • AUC (area under the curve)

Secondary Outcomes (3)

  • Cmax, maximum concentration

  • tmax, time to maximum concentration

  • t½, terminal half-life

Study Arms (2)

NNC 90-1170 (liraglutide)

EXPERIMENTAL
Drug: liraglutide

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

liraglutideDRUG

Administered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order

Also known as: NNC 90-1170
NNC 90-1170 (liraglutide)
placeboDRUG

Administered s.c. After a wash-out of at least 7 days, a single i.v. (into the vein) dose is administered

Placebo

Eligibility Criteria

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

You may qualify if:

  • Male subjects of any ethnic origin
  • Written informed consent obtained. (The subject must give signed informed consent before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject)
  • Good general health based on medical history, physical and laboratory examinations, incl. ECG (electrocardiogram)
  • Body mass index within the range 20-27 kg/m\^2, inclusive

You may not qualify if:

  • Any clinically significant abnormal laboratory test results or clinically significant abnormal ECG
  • History of alcoholism or drug addiction; positive results in the plasma urine screens for illicit drug
  • Alcohol intake within 48 hours of visit
  • Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies
  • History of significant drug allergy or drug hypersensitivity
  • Smoke 5 cigarettes or more, or the equivalent per day and is unable to refrain from smoking during the 3 days prior to the dosing day and during the confinement period
  • Subjects who drink more than 8 cups of tea/coffee per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Manchester, M15 6SH, United Kingdom

Location

Related Publications (2)

  • Elbrond B, Jakobsen G, Larsen S, Agerso H, Jensen LB, Rolan P, Sturis J, Hatorp V, Zdravkovic M. Pharmacokinetics, pharmacodynamics, safety, and tolerability of a single-dose of NN2211, a long-acting glucagon-like peptide 1 derivative, in healthy male subjects. Diabetes Care. 2002 Aug;25(8):1398-404. doi: 10.2337/diacare.25.8.1398.

    PMID: 12145241RESULT

  • Agerso H, Vicini P. Pharmacodynamics of NN2211, a novel long acting GLP-1 derivative. Eur J Pharm Sci. 2003 Jun;19(2-3):141-50. doi: 10.1016/s0928-0987(03)00073-3.

    PMID: 12791417RESULT

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

January 5, 2012

First Posted

January 10, 2012

Study Start

March 1, 1999

Primary Completion

December 1, 1999

Study Completion

December 1, 1999

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

GB(1)