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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes
• Interventions: Drug: insulin degludec/insulin aspart

• Registration Number: NCT01455142
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-17
• Study First Submitted QC: 2011-10-18
• Study First Posted: 2011-10-19
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-19
• Last Update Posted: 2015-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Formulation 1	insulin degludec/insulin aspart	-
Formulation 2	insulin degludec/insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Area under the serum insulin aspart concentration-time curve	From 0 to 12 hours after single-dose
Maximum observed serum insulin degludec concentration	After single-dose (within 0 to 120 hours after dosing)
Area under the serum insulin degludec concentration-time curve	From 0 to 120 hours after single-dose (SD)
Maximum observed serum insulin aspart concentration	After single-dose (within 0 to 12 hours after dosing)

Secondary Outcome Measures

Name	Time	Method
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)