Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Healthy Volunteers
A Single Centre, Randomized, Balanced Double Blind, Cross-over Trial Investigating the Bioequivalence of Actrapid® Produced by the Current Process and Human Insulin With the Same Formulation as Actrapid®, Produced by the NN729 Process
1 other identifier
interventional
28
1 country
1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to show that the product of the new production process has a similar pharmacological profile to the traditional process used for the current commercial product Actrapid®.
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 2002
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
October 15, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2002
CompletedFirst Submitted
Initial submission to the registry
October 5, 2011
CompletedFirst Posted
Study publicly available on registry
October 7, 2011
CompletedFebruary 27, 2017
February 1, 2017
2 months
October 5, 2011
February 23, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
AUC (area under the curve) 0-8h (human insulin)
Cmax (maximum plasma concentration)
Area under the curve (glucose infusion rate (GIR)), 0-8h
Secondary Outcomes (6)
tmax (time to reach maximum)
t½ (terminal half-life)
GIR (glucose infusion rate) max
tGIR (glucose infusion rate) max
Area under the curve (C-peptide, 0-8h)
- +1 more secondary outcomes
Study Arms (2)
NN729 manufacturing process
EXPERIMENTALCurrent manufacturing process
ACTIVE COMPARATORInterventions
Single dose of 0.2 IU/kg, administered subcutaneously (under the skin)
Eligibility Criteria
You may qualify if:
- Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
- Fasting blood glucose below or equal to 6 mmol/L
- Body Mass Index (BMI) 22.0-27.0 kg/m\^2 (both inclusive)
You may not qualify if:
- Participated in another clinical study with an investigational drug within the last 4 weeks
- Any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. Occasional paracetamol is acceptable
- Known or suspected allergy to the trial product or related products
- Family history of type 1 diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Manchester, M15 6SH, United Kingdom
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
October 5, 2011
First Posted
October 7, 2011
Study Start
October 15, 2002
Primary Completion
December 20, 2002
Study Completion
December 20, 2002
Last Updated
February 27, 2017
Record last verified: 2017-02