A Trial Investigating NN1218 in Subjects With Type 1 Diabetes
A Trial Investigating the Pharmacokinetic Properties of NN1218 in Subjects With Type 1 Diabetes
3 other identifiers
interventional
26
1 country
1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate the absorption and effect in the body of NN1218 in subjects with type 1 diabetes.
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 Apr 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
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 10, 2010
CompletedFirst Posted
Study publicly available on registry
May 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedDecember 10, 2013
December 1, 2013
3 months
May 10, 2010
December 9, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the serum NN1218 concentration-time curve
From 0-1 hours
Secondary Outcomes (1)
Area under the serum NN1218 concentration-time curve
From 0-10 hours
Study Arms (6)
NN1218, formulation A
EXPERIMENTALNN1218, formulation B
EXPERIMENTALNN1218, formulation B (high)
EXPERIMENTALNN1218, formulation C
EXPERIMENTALNN1218, formulation D
EXPERIMENTALinsulin aspart
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Type 1 diabetes mellitus for more than 12 months
- Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months
- Body mass index (BMI) between 18.0-28.0 kg/m2 (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)
Unknown Facility
Neuss, 41460, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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 10, 2010
First Posted
May 12, 2010
Study Start
April 1, 2010
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
December 10, 2013
Record last verified: 2013-12