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Clinical Trials/NCT01486901
NCT01486901
Completed
Phase 1

A Randomised, Single Centre, Double-blind, Two-period Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Insulatard® (600 Nmol/ml) and Insulatard® (1998 Nmol/ml) in Healthy Subjects

Novo Nordisk A/S0 sites44 target enrollmentMay 2006
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ConditionsDiabetesHealthy
Interventionsisophane human insulin
Drugsisophane human insulin

Overview

Phase
Phase 1
Intervention
isophane human insulin
Conditions
Diabetes
Sponsor
Novo Nordisk A/S
Enrollment
44
Primary Endpoint
Area under the serum insulin concentration-time curve (AUC 0-24 hours)
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief Summary

This trial is conducted in Europe. The aim of this trial is to test for bioequivalence between two formulations of Insulatard® in healthy subjects.

Registry
clinicaltrials.gov
Start Date
May 2006
End Date
July 2006
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
  • •Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2, inclusive
  • •Non-smoker, defined as no nicotine consumption for at least one year
  • •Fasting plasma glucose below or equal to 100 mg/dL (5.6 mmol/L)

Exclusion Criteria

  • •Previous participation in this trial or other clinical trials within the last 3 months
  • •Body weight above 87.5 kg
  • •Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, or sterilisation, or the oral contraceptive pill, which should have been taken without difficulty for at least 3 months, an approved hormonal implant)
  • •History of alcohol or drug abuse

Arms & Interventions

Formulation A

Intervention: isophane human insulin

Formulation B

Intervention: isophane human insulin

Outcomes

Primary Outcomes

Area under the serum insulin concentration-time curve (AUC 0-24 hours)

Maximum serum insulin concentration (Cmax)

Secondary Outcomes

  • Adverse events
  • Area under the serum insulin concentration-time curve (AUC 0-inifinity hours)
  • Time to maximum serum insulin concentration (tmax)
  • Terminal serum insulin half life (t½)

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