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Clinical Trials/NCT01497535
NCT01497535CompletedPhase 1

A Single-centre, Parallel-group, Randomised, Double Blind Trial in Healthy Japanese Subjects Comparing the Within-subject Variability of Insulin Detemir and Insulin Glargine With Respect to Pharmacodynamic and Pharmacokinetic Properties

Novo Nordisk A/S1 site in 1 country40 target enrollmentStarted: May 27, 2004Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Maximum glucose infusion rate (GIRmax)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare the within-subject variability of insulin detemir to that of another basal insulin analogue, insulin glargine in healthy volunteers.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Healthy Japanese men or women
  • •Holding a Japanese pass-port and Japanese-born parents
  • •Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
  • •Body Mass Index (BMI) between 18 and 30 kg/m^2, incl.
  • •Fasting blood glucose maximum 6 mmol/L

Exclusion Criteria

  • •Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator
  • •Any serious systemic infectious disease that occurred during the four weeks prior to the first dose of the trial product, as judged by the Investigator
  • •Subject with history of alcohol or drug dependence

Arms & Interventions

Insulin detemir

Experimental

Intervention: insulin detemir (Drug)

Insulin glargine

Active Comparator

Intervention: insulin glargine (Drug)

Outcomes

Primary Outcomes

Maximum glucose infusion rate (GIRmax)

Secondary Outcomes

  • Area under the glucose infusion rate curve (AUCGIR)
  • Time to maximum glucose infusion rate (tGIRmax)
  • Area under the insulin concentration curve (AUC)
  • Maximum insulin concentration (Cmax)
  • Adverse events

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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