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Clinical Trials/NCT00992537
NCT00992537
Completed
Phase 1

A Trial Comparing the Pharmacokinetic and Pharmacodynamic Properties Between NN5401 and NN1250 and Between NN5401 and Insulin Aspart in Subjects With Type 1 Diabetes

Novo Nordisk A/S0 sites27 target enrollmentStarted: October 2009Last updated:
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ConditionsDiabetesDiabetes Mellitus, Type 1
Interventionsinsulin aspartinsulin degludecinsulin degludec/insulin aspart
Drugsinsulin degludecinsulin degludec/insulin aspartinsulin aspart

Overview

Phase
Phase 1
Status
Completed
Enrollment
27
Primary Endpoint
Area under the glucose infusion rate curve
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This trial is conducted in Europe. The aim of this clinical trial is to compare the blood glucose lowering effect of NN5401(insulin degludec/insulin aspart (IDegAsp)) with NN1250 (insulin degludec (IDeg)) and insulin aspart (IAsp) in subjects with type 1 diabetes where the trial participant will receive one single dose of each trial product in varying order.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • •Body mass index 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria

  • •Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • •Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day).
  • •Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Arms & Interventions

IAsp

Active Comparator

Intervention: insulin aspart (Drug)

IDeg

Experimental

Intervention: insulin degludec (Drug)

IDegAsp

Experimental

Intervention: insulin degludec/insulin aspart (Drug)

Outcomes

Primary Outcomes

Area under the glucose infusion rate curve

Time Frame: From 4 to 24 hours after single-dose administration

Secondary Outcomes

  • Area under the insulin degludec concentration-time curve(From 0 to 120 hours after single-dose administration)
  • Maximum observed insulin degludec concentration(From 0 to 120 hours after single-dose administration)
  • Area under the insulin aspart concentration-time curve(From 0 to 12 hours after single-dose administration)
  • Maximum observed insulin aspart concentration(0-12 hours after single-dose administration)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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