A Comparison Between Two Formulations of NN5401 in Healthy Subjects
A Trial to Test for Bioequivalence Between Two NN5401 Formulations in Healthy Subjects
2 other identifiers
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 diabetes
Started May 2010
Shorter than P25 for phase_1 diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 7, 2010
CompletedFirst Posted
Study publicly available on registry
May 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedSeptember 25, 2015
September 1, 2015
3 months
May 7, 2010
September 24, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
Area under the serum insulin degludec concentration-time curve
from 0 to 120 hours after single-dose
Maximum observed serum insulin degludec concentration
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
Maximum observed serum insulin aspart concentration
from 0 to 12 hours after single-dose
Secondary Outcomes (2)
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
Study Arms (2)
IDegAsp B
EXPERIMENTALIDegAsp F
EXPERIMENTALInterventions
Each subject will be allocated to two single injections of trial product on two separate dosing visits with each of the two insulin degludec/insulin aspart formulations. The trial products will be administered as a subcutaneous injection (under the skin).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Clinical Trial Call Center
Chula Vista, California, 91911, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2010
First Posted
May 18, 2010
Study Start
May 1, 2010
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
September 25, 2015
Record last verified: 2015-09