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Clinical Trials/NCT01455142
NCT01455142CompletedPhase 1

A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes

Novo Nordisk A/S0 sites32 target enrollmentStarted: October 2011Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
32
Primary Endpoint
Area under the serum insulin aspart concentration-time curve

Study Overview

Brief Summary

This trial is conducted in Europe. The aim of the trial is to test for bioequivalence between two formulations of insulin degludec/insulin aspart (IDegAsp) to see if the efficacy and safety obtained with formulation 1 can be assumed identical for formulation 2.

Study Design

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

Eligibility Criteria

Ages
18 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer
  • Body mass index from 18.0 to 28.0 kg/m^2 (both inclusive)
  • HbA1c below or equal to 9.5% by central laboratory analysis

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

Formulation 1

Experimental

Intervention: insulin degludec/insulin aspart (Drug)

Formulation 2

Experimental

Intervention: insulin degludec/insulin aspart (Drug)

Outcomes

Primary Outcomes

Area under the serum insulin aspart concentration-time curve

Time Frame: From 0 to 12 hours after single-dose

Maximum observed serum insulin degludec concentration

Time Frame: After single-dose (within 0 to 120 hours after dosing)

Area under the serum insulin degludec concentration-time curve

Time Frame: From 0 to 120 hours after single-dose (SD)

Maximum observed serum insulin aspart concentration

Time Frame: After single-dose (within 0 to 12 hours after dosing)

Secondary Outcomes

  • Area under the glucose infusion rate curve(From 0 to 26 hours after single-dose)
  • Maximum glucose infusion rate(After single-dose (within 0 to 120 hours after dosing))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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