A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes
3 other identifiers
interventional
32
1 country
1
Brief Summary
This trial is conducted in Europe. The aim of the trial is to test for bioequivalence between two formulations of insulin degludec/insulin aspart (IDegAsp) to see if the efficacy and safety obtained with formulation 1 can be assumed identical for formulation 2.
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 Oct 2011
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 17, 2011
CompletedFirst Posted
Study publicly available on registry
October 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFebruary 23, 2015
February 1, 2015
3 months
October 17, 2011
February 19, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
Area under the serum insulin degludec concentration-time curve
From 0 to 120 hours after single-dose (SD)
Maximum observed serum insulin degludec concentration
After single-dose (within 0 to 120 hours after dosing)
Area under the serum insulin aspart concentration-time curve
From 0 to 12 hours after single-dose
Maximum observed serum insulin aspart concentration
After single-dose (within 0 to 12 hours after dosing)
Secondary Outcomes (2)
Area under the glucose infusion rate curve
From 0 to 26 hours after single-dose
Maximum glucose infusion rate
After single-dose (within 0 to 120 hours after dosing)
Study Arms (2)
Formulation 1
EXPERIMENTALFormulation 2
EXPERIMENTALInterventions
Single injection of each formulation. The dose level will be 0.5 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).
Eligibility Criteria
You may qualify if:
- Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer
- Body mass index from 18.0 to 28.0 kg/m\^2 (both inclusive)
- HbA1c below or equal to 9.5% by central laboratory analysis
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)
Unknown Facility
Graz, 8010, Austria
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
October 17, 2011
First Posted
October 19, 2011
Study Start
October 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
February 23, 2015
Record last verified: 2015-02