A Comparison Between Two Formulations of NN5401 in Healthy Subjects

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: insulin degludec/insulin aspart

• Registration Number: NCT01125553
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in the United States of America (USA). The aim of the trial is to compare the exposure of two formulations of insulin degludec/insulin aspart (NN5401) in healthy subjects.

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: 2010-05
• Study First Submitted: 2010-05-07
• Study First Submitted QC: 2010-05-17
• Study First Posted: 2010-05-18
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-24
• Last Update Posted: 2015-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the physician
• Body mass index between 18.0 and 27.0 kg/m^2 (both inclusive)

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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 trial start
• 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 B	insulin degludec/insulin aspart	-
IDegAsp F	insulin degludec/insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Maximum observed serum insulin degludec concentration	from 0 to 120 hours after single-dose
Maximum observed serum insulin aspart concentration	from 0 to 12 hours after single-dose
Area under the serum insulin degludec concentration-time curve	from 0 to 120 hours 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
Time to maximum observed serum insulin degludec concentration	from 0 to 120 hours after single-dose
Time to maximum observed serum insulin aspart concentration	from 0 to 12 hours after single-dose

Trial Locations

Locations (1)

Novo Nordisk Clinical Trial Call Center; 🇺🇸 Chula Vista, California, United States