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Trial · Interventional

CompletedPhase 1Registry data

Safety and Tolerability of NN9068 in Healthy Male Volunteers

NCTNCT00983021 (opens ClinicalTrials.gov in a new tab)Other idNN9068-3632Other id2009-011269-95Other idU1111-1111-8859Other id2009
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

Germany

Start
Sept 2009
Primary completion
Dec 2009
Completion
Dec 2009
First posted
23 Sept 2009 (estimated)
Last update posted
8 Feb 2017 (estimated)
Conditions
Diabetes · Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20092010
  1. Ph 1

    Safety and Tolerability of NN9068 in Healthy Male Volunteers

    NCT00983021

    Sept 2009 to Dec 2009

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 clinical trial is to investigate the safety, tolerability, level of drug exposure and effect of NN9068. The trial participants will be randomised to 4 different treatments in trial, receiving trial products in a pre-defined order.

Interventions

  • insulin degludec/liraglutideDrug
  • insulin degludecDrug
  • liraglutideDrug
  • placeboDrug

Arms4

  • Experimental

    A

  • Experimental

    B

  • Active comparator

    C

  • Experimental

    D

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number and severity of adverse events, number and severity of local tolerability issues at the injection site, number and severity of hypoglycaemic episodes

    Time frame · assessed 0-96 hours after trial product administration

Secondary outcomes(2)

  1. The area under the NN2211 concentration-time curve after single-dose

    Time frame · assessed 0-72 hours after trial product administration

  2. The area under the NN1250 concentration-time curve after single-dose

    Time frame · assessed 0-96 hours after trial product administration

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 · 2015

4 results

Preserved pharmacokinetic exposure and distinct glycemic effects of insulin degludec and liraglutide in IDegLira, a fixed-ratio combination therapy.

Kapitza et al. 2015Journal of clinical pharmacologycited by 23

PMID 25998481DOI 10.1002/jcph.549PUB-25998481

Full text at the publisher4 results
Publisher pageSee results (4)

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 55 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male subjects, who are considered to be generally healthy, based on an assessment of medical history, physical examination, and clinical laboratory data, as judged by the Investigator. * Body mass index (BMI) between 18.0 and 27.0 kg/m2 (both inclusive) * Body weight between 60 kg and 90 kg (both inclusive) Exclusion Criteria: * Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the current trial, as judged by the Investigator

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