Effect of NN5401 in Japanese Subjects With Type 1 Diabetes

Phase 1

Completed

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

• Registration Number: NCT01051102
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Japan. The aim of this clinical trial is to investigate the blood sugar lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in Japanese subjects with type 1 diabetes. Each subject will be randomised to one of the two possible treatment sequences (NN5401 followed by biphasic insulin aspart (BIAsp) 30 or biphasic insulin aspart 30 followed by NN5401).

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: 2010-01
• Study First Submitted: 2010-01-15
• Study First Submitted QC: 2010-01-15
• Study First Posted: 2010-01-18
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

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

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Exclusion Criteria

• Loss of more than 400 mL blood (inclusive) in total with in the last 12 weeks or more than 200 mL blood (inclusive) in total within the last 4 weeks prior to screening
• Smoker (defined as a subject who is smoking more than 5 cigarettes (not inclusive 5) 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	insulin degludec/insulin aspart	-
BIAsp 30	biphasic insulin aspart 30	-

Primary Outcome Measures

Name	Time	Method
Area under the Glucose Infusion Rate curve after a single dose	From 4-12 hours

Secondary Outcome Measures

Name	Time	Method
Area under the insulin aspart concentration-time curve after a single dose	From 0-12 hours

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan