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Trial · Interventional

CompletedPhase 1Registry data

Safety and Tolerability of Liraglutide in Healthy Male Volunteers

NCTNCT01507272 (opens ClinicalTrials.gov in a new tab)Other idNN2211-1149
Open at ClinicalTrials.govAsk about this trial

Overview

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

United Kingdom

Start
Mar 1999
Primary completion
Dec 1999
Completion
Dec 1999
First posted
10 Jan 2012 (estimated)
Last update posted
24 Jan 2017 (estimated)
Conditions
Diabetes · Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
19992000
  1. Ph 1

    Safety and Tolerability of Liraglutide in Healthy Male Volunteers

    NCT01507272

    Mar 1999 to Dec 1999

Registry summary

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

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).

Interventions

  • liraglutideDrug
  • liraglutideDrug
  • placeboDrug
  • placeboDrug

Arms2

  • Experimental

    NNC 90-1170 (liraglutide)

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. AUC (area under the curve)

Secondary outcomes(3)

  1. Cmax, maximum concentration

  2. tmax, time to maximum concentration

  3. t½, terminal half-life

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

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2003

1 result

Pharmacodynamics of NN2211, a novel long acting GLP-1 derivative.

Agersø et al. 2003European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciencescited by 52

PMID 12791417DOI 10.1016/s0928-0987(03)00073-3PUB-12791417

Full text at the publisher1 result
Publisher pageSee results (1)

Indexing hint: Randomized controlled trial · 2002

14 results

Pharmacokinetics, pharmacodynamics, safety, and tolerability of a single-dose of NN2211, a long-acting glucagon-like peptide 1 derivative, in healthy male subjects.

Elbrønd et al. 2002Diabetes carecited by 210

PMID 12145241DOI 10.2337/diacare.25.8.1398PUB-12145241

Full text at the publisher14 results
Publisher pageSee results (14)

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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

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