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Clinical Trials/NCT01707160
NCT01707160
Completed
Phase 1

A Randomised, Double-blind 2 Way Crossover Trial to Investigate the Pharmacokinetics and Pharmacodynamics of Insulin X14 30/70 PreMix Compared to Human Insulin 30/70 PreMix in Healthy Volunteers

Novo Nordisk A/S1 site in 1 country24 target enrollmentNovember 1995
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ConditionsDiabetesHealthy
Interventionsbiphasic insulin aspart 30biphasic human insulin 30
Drugsbiphasic insulin aspart 30biphasic human insulin 30

Overview

Phase
Phase 1
Intervention
biphasic insulin aspart 30
Conditions
Diabetes
Sponsor
Novo Nordisk A/S
Enrollment
24
Locations
1
Primary Endpoint
Area under the Curve
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics and pharmacodynamics of insulin X14 30/70 PreMix compared to human insulin 30/70 PreMix in healthy volunteers.

Registry
clinicaltrials.gov
Start Date
November 1995
End Date
December 1995
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Non-smokers
  • •BMI (body mass index) maximum 27 kg/m\^2
  • •HbA1c (glycosylated haemoglobin A1c): 3.4-6.1%
  • •FBG (fasting blood glucose) maximum 6.0 mmol/L

Exclusion Criteria

  • Not provided

Arms & Interventions

Treatment period 1

Intervention: biphasic insulin aspart 30

Treatment period 1

Intervention: biphasic human insulin 30

Treatment period 2

Intervention: biphasic insulin aspart 30

Treatment period 2

Intervention: biphasic human insulin 30

Outcomes

Primary Outcomes

Area under the Curve

Secondary Outcomes

  • Maximum insulin concentration (Cmax)
  • Time to maximum insulin concentration (tmax)
  • Adverse events
  • Minimum glucose concentration (Cmin(glu))
  • Time to minimum glucose concentration (tmin(glu))

Study Sites (1)

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