A Trial Investigating the Effect of NN5401 in Subjects With Type 2 Diabetes

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin degludec/insulin aspart; Drug: biphasic insulin aspart 30

• Registration Number: NCT01134224
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the blood glucose-lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in subjects with type 2 diabetes.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-27
• Study First Submitted QC: 2010-05-27
• Study First Posted: 2010-05-31
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-26
• Last Update Posted: 2013-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
• Body mass index below or equal to 35.0 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
• 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
NN5401 - low dose	insulin degludec/insulin aspart	-
biphasic insulin aspart 30 - low dose	biphasic insulin aspart 30	-
biphasic insulin aspart 30 - medium dose	biphasic insulin aspart 30	-
biphasic insulin aspart 30 - high dose	biphasic insulin aspart 30	-
NN5401 - medium dose	insulin degludec/insulin aspart	-
NN5401 - high dose	insulin degludec/insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Area under the glucose infusion rate curve (only for IDegAsp)	From 0 to 24 hours after single-dose

Secondary Outcome Measures

Name	Time	Method
Area under the insulin aspart concentration-time curve	From 0 to 12 hours after single-dose administration
Area under the insulin aspart concentration-time curve (only for BIAsp 30)	From 0 to 24 hours after single-dose administration