A Trial Investigating the Exposure of NN5401 in Young Adults and Elderly Subjects With Type 1 Diabetes

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: insulin degludec/insulin aspart; Drug: biphasic insulin aspart 30

• Registration Number: NCT01174303
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the exposure of NN5401 (insulin degludec/insulin aspart) in young adults and elderly subjects with type 1 diabetes mellitus.

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: 2010-08
• Study First Submitted: 2010-08-02
• Study First Submitted QC: 2010-08-02
• Study First Posted: 2010-08-03
• 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: 28

Inclusion Criteria

• Male or female aged 18-35 years (both inclusive) (young group) or at least 65 years (geriatric group)
• Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
• Body mass index 18.0-28.0 kg/m^2 (both inclusive)
• HbA1c (glycosylated haemoglobin A1c) maximum 10.0% 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
IDegAsp - BIAsp	insulin degludec/insulin aspart	-
BIAsp - IDegAsp	insulin degludec/insulin aspart	-
IDegAsp - BIAsp	biphasic insulin aspart 30	-
BIAsp - IDegAsp	biphasic insulin aspart 30	-

Primary Outcome Measures

Name	Time	Method
Area under the Glucose Infusion Rate curve (only for NN5401)	from 0 to 24 hours after single-dose administration

Secondary Outcome Measures

Name	Time	Method
Area under the glucose infusion rate curve (only for biphasic insulin aspart 30)	from 0 to 24 hours after single-dose administration

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇦🇹 Graz, Austria