Comparison of Insulin Detemir Produced by the Current Process and the NN729 Process in Healthy Subjects
A Randomised, Single Centre, Double-blind, Two-period Cross-over Glucose Clamp Trial to Demonstrate Bioequivalence Between Insulin Detemir Produced by the NN729 Process and Insulin Detemir Produced by the Current Process in Healthy Subjects
2 other identifiers
interventional
37
1 country
1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to demonstrate bioequivalence between insulin detemir produced by the NN729 process and by the current process in healthy subjects.
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 Aug 2006
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
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 6, 2011
CompletedFirst Posted
Study publicly available on registry
December 12, 2011
CompletedFebruary 8, 2016
February 1, 2016
3 months
December 6, 2011
February 5, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
AUC0-36h, area under the serum insulin detemir concentration curve
From 0 to 36 hours
Cmax, maximum serum insulin detemir concentration
Secondary Outcomes (5)
AUC, area under the serum insulin detemir concentration curve
Time to maximum concentration (tmax)
Terminal half life (t½)
Area under the Curve Glucose Infusion Rate (AUCGIR)
Adverse events
Study Arms (2)
Treatment period 1
EXPERIMENTALTreatment period 2
ACTIVE COMPARATORInterventions
One single dose of insulin detemir produced by current process and the NN729 process injected subcutaneously on two separate dosing visits in varying order
Eligibility Criteria
You may qualify if:
- Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
- Body mass index (BMI) between 18.0 and 27.0 kg/m\^2, inclusive
- Non-smoker
- Fasting plasma glucose (FPG) maximum 6.0 mmol/L
You may not qualify if:
- Known or suspected allergy to trial products or related products
- Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, sterilisation, the oral contraceptive pill (which should have been taken without difficulty for at least 3 months) or an approved hormonal implant)
- A history of alcohol or drug abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Unknown Facility
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
December 6, 2011
First Posted
December 12, 2011
Study Start
August 1, 2006
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
February 8, 2016
Record last verified: 2016-02