A Trial Investigating the Total Exposure of NN5401 (Insulin Degludec/Insulin Aspart) in Children, Adolescents and Adult Subjects With Type 1 Diabetes

Phase 1

Completed

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

• Registration Number: NCT01138488
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial was conducted in Europe. The aim of this study was to investigate the total exposure of NN5401 (insulin degludec/insulin aspart) in children, adolescents and adult subjects with type 1 diabetes.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-04
• Study First Submitted QC: 2010-06-04
• Study First Posted: 2010-06-07
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
• Body mass index for children: 15.0-20.0 kg/m^2 (both inclusive), for adolescents: 18.0-28.0 kg/m^2 (both inclusive) and for adults maximum 30.0 kg/m^2

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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
• Not able or willing to refrain from smoking during the inpatient period
• Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NN5401	insulin degludec/insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Area under the serum insulin degludec concentration-time curve	from 0 to infinity after single-dose
Area under the serum insulin aspart concentration-time curve	from 0 to 12 hours after single-dose

Secondary Outcome Measures

Name	Time	Method
Maximum observed insulin degludec concentration of NN5401 (insulin degludec/insulin aspart) observed	from 0 to 57 hours after single-dose
Maximum observed insulin aspart concentration of NN5401 (insulin degludec/insulin aspart) observed	from 0 to 12 hours after single-dose

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Hannover, Germany