Comparison of Two NN1250 Formulations in Healthy Volunteers
A Trial to Test for Bioequivalence Between Two NN1250 Formulations in Healthy Subjects
5 other identifiers
interventional
27
1 country
1
Brief Summary
This trial was conducted in North America. The aim of this clinical trial was to investigate if two formulations of NN1250 (insulin degludec) have the same level of drug exposure to the body.
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 Aug 2009
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
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 25, 2009
CompletedFirst Posted
Study publicly available on registry
August 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedSeptember 28, 2015
September 1, 2015
2 months
August 25, 2009
September 24, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Area under the Insulin Degludec concentration-time curve from 0 to 120 hours after single dose
From 0 to 120 hours after dosing
Maximum observed Insulin Degludec concentration after single dose
From 0 to 120 hours after dosing
Secondary Outcomes (3)
Time to maximum observed Insulin Degludec concentration after single dose
From 0 to 120 hours after dosing
Area under the Insulin Degludec concentration-time curve from 0 to 24 hours after single dose
From 0-24 hours after dosing
Terminal half-life for Insulin Degludec
From 0 to 120 hours after dosing
Study Arms (2)
IDeg E
EXPERIMENTALIDeg M
EXPERIMENTALInterventions
Single dose of NN1250, formulation 1, 0.4U/kg body weight injected subcutaneously (under the skin)
Eligibility Criteria
You may qualify if:
- Considered generally healthy upon completion of medical history, physical examination, vital signs and ECG (electrocardiogram), as judged by the Investigator
- Body mass index 18.0-27.0 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 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
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, 91911-1350, 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
August 25, 2009
First Posted
August 26, 2009
Study Start
August 1, 2009
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
September 28, 2015
Record last verified: 2015-09