Comparison of Two Insulin Detemir Formulations in Healthy Volunteers
A Randomised, Single Centre, Two-period, Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Two Insulin Detemir Formulations Containing Mannitol and Glycerol as Isotonic Agents Respectively, in Healthy Subjects
2 other identifiers
interventional
34
1 country
1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to compare two formulations of insulin detemir containing an isotonic agent in healthy volunteers.
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 Nov 2005
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
November 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 21, 2011
CompletedFirst Posted
Study publicly available on registry
December 26, 2011
CompletedJanuary 14, 2015
January 1, 2015
3 months
December 21, 2011
January 13, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Area under the serum insulin detemir concentration curve
Maximum serum insulin concentration
Secondary Outcomes (7)
Area under the glucose infusion rate curve
Time to maximum serum insulin concentration
Terminal serum insulin half life
Area under the serum insulin detemir concentration curve
Maximum glucose infusion rate
- +2 more secondary outcomes
Study Arms (2)
Glycerol
EXPERIMENTALMannitol
ACTIVE COMPARATORInterventions
Single dose containing mannitol as isotonic agent. Administered subcutaneously (s.c., under the skin)
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 and 27 kg/m\^2, inclusive
- Non-smoker
- Fasting plasma glucose maximum 6 mmol/L
You may not qualify if:
- Known or suspected allergy to trial products or related products
- Previous participation in this trial
- 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)
- The receipt of any investigational drug within the last 3 months prior to this trial
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
Study Record Dates
First Submitted
December 21, 2011
First Posted
December 26, 2011
Study Start
November 1, 2005
Primary Completion
February 1, 2006
Study Completion
February 1, 2006
Last Updated
January 14, 2015
Record last verified: 2015-01