Comparison of Two NN1250 Formulations in Subjects With Type 1 Diabetes
A Trial Investigating the Pharmacodynamic Properties of NN1250 in Subjects With Type 1 Diabetes
3 other identifiers
interventional
33
1 country
1
Brief Summary
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic properties (effect) by comparing two NN1250 (insulin degludec, IDeg) formulations 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 Feb 2010
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
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 24, 2010
CompletedFirst Posted
Study publicly available on registry
February 26, 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
CompletedJanuary 23, 2017
January 1, 2017
5 months
February 24, 2010
January 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the glucose infusion rate curve during one dosing interval at steady-date"
After 8 days of treatment
Secondary Outcomes (2)
Area under the serum Insulin Degludec concentration-time curve
During one dosing interval at steady state
Area under the serum Insulin Degludec concentration-time curve
From 0 to 24 hours after single dose
Study Arms (2)
IDeg 100 U/mL
EXPERIMENTALIDeg 200 U/mL
EXPERIMENTALInterventions
0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days.
Eligibility Criteria
You may qualify if:
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Body mass index 18.0-28.0 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 Investigational Site
Graz, 8010, Austria
Related Publications (1)
Korsatko S, Deller S, Koehler G, Mader JK, Neubauer K, Adrian CL, Thomsen H, Haahr H, Pieber TR. A comparison of the steady-state pharmacokinetic and pharmacodynamic profiles of 100 and 200 U/mL formulations of ultra-long-acting insulin degludec. Clin Drug Investig. 2013 Jul;33(7):515-21. doi: 10.1007/s40261-013-0096-7.
PMID: 23749405RESULT
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
February 24, 2010
First Posted
February 26, 2010
Study Start
February 1, 2010
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
January 23, 2017
Record last verified: 2017-01