Comparison of the Effect of NN5401 With the Effect of NN1250 and Insulin Aspart in Subjects With Type 1 Diabetes

Phase 1

Completed

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

• Registration Number: NCT01173926
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare the blood glucose-lowering effect of NN5401 (insulin degludec/insulin aspart, IDegAsp) with NN1250 (insulin degludec, IDeg) and insulin aspart (IAsp) in subjects with type 1 diabetes mellitus.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-30
• Study First Submitted QC: 2010-07-30
• Study First Posted: 2010-08-02
• 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: 27

Inclusion Criteria

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IDegAsp	insulin degludec/insulin aspart	-
IAsp	insulin aspart	-
IDeg	insulin degludec	-

Primary Outcome Measures

Name	Time	Method
Area under the glucose infusion rate curve	From 6 to 24 hours after single-dose (only for IDegAsp and IAsp)

Secondary Outcome Measures

Name	Time	Method
Area under the serum insulin aspart concentration-time curve	From 0 to 12 hours after single-dose (only for IDegAsp and IAsp)
Area under the serum insulin degludec concentration-time curve	From 0 to 120 hours after single-dose (only for IDeg and IDegAsp)