Comparison of Two Identical NN1250 Formulations in Healthy Volunteers
A Trial to Test for Bioequivalence Between Identical NN1250 Formulations, IM1 and IM2, in Healthy Subjects
3 other identifiers
interventional
26
1 country
1
Brief Summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate if two identical formulations of NN1250 (insulin degludec, IDeg) 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 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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 31, 2010
CompletedFirst Posted
Study publicly available on registry
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedNovember 27, 2013
November 1, 2013
3 months
August 31, 2010
November 26, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Area under the Insulin Degludec concentration-time curve
From 0 to 120 hours after single-dose
Maximum observed Insulin Degludec concentration
From 0 to 120 hours after single-dose
Secondary Outcomes (1)
Area under the Insulin Degludec concentration-time curve
From 0 to infinity after single-dose
Study Arms (2)
IDeg (M) IM1
EXPERIMENTALIDeg (M) IM2
EXPERIMENTALInterventions
Each subject will be allocated to 2 single doses of trial product on 2 separate visits: One injection with formulation 1 and and one injection with formulation 2). Injected subcutaneously (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 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
- Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Unknown Facility
Neuss, 41460, Germany
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 31, 2010
First Posted
September 1, 2010
Study Start
August 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
November 27, 2013
Record last verified: 2013-11