Investigation of Pharmacodynamic Characteristics of Explorative Formulation of Insulin Degludec in Male Subjects With Type 1 Diabetes
A Single Centre, Open-Label, Multiple Dose Trial Examining the Pharmacodynamic Characteristics of Insulin 454 Under Single-Dose and Steady-State Conditions in Male Subjects With Type 1 Diabetes
2 other identifiers
interventional
36
1 country
1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, under single-dose and steady-state conditions in male subjects with type 1 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 diabetes
Started Sep 2006
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
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 27, 2013
CompletedFirst Posted
Study publicly available on registry
May 30, 2013
CompletedOctober 22, 2015
October 1, 2015
4 months
May 27, 2013
October 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the glucose infusion rate curve
0-24 hours after dosing
Secondary Outcomes (3)
Maximum glucose infusion rate (GIRmax)
0-24 hours after dosing
Time to maximum glucose infusion rate (tGIRmax)
0-24 hours after dosing
Area under the serum insulin degludec curve
0-96 hours after dosing
Study Arms (3)
Part 1 (Once-daily dosing regimen, high concentration)
EXPERIMENTALPart 2 (Twice-daily dosing regimen, high concentration)
EXPERIMENTALPart 3 (Once-daily dosing regimen, low concentration)
EXPERIMENTALInterventions
Administered subcutaneously (s.c., under the skin)
Eligibility Criteria
You may qualify if:
- Male and are considered to be generally healthy, except for the underlying diabetes mellitus, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
- Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months
- Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive)
- Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results
You may not qualify if:
- History of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator
- Participation in any other trials involving investigational products within 3 months preceding the start of dosing
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
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2013
First Posted
May 30, 2013
Study Start
September 1, 2006
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
October 22, 2015
Record last verified: 2015-10