Bioequivalence of Two Mixtard® 30 Formulations in Healthy Subjects
A Randomised, Single Centre, Double-blind, Two-period Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Insulin Mixtard® 30 (600 Nmol/ml) and Insulin Mixtard® 30 (1998 Nmol/ml) in Healthy Subjects
2 other identifiers
interventional
45
1 country
1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to to test for bioequivalence between two formulations of Mixtard® 30 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 May 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
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 5, 2011
CompletedFirst Posted
Study publicly available on registry
December 7, 2011
CompletedMarch 18, 2015
March 1, 2015
2 months
December 5, 2011
March 17, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Area under the serum insulin concentration-time curve (AUC 0-24 hours)
Maximum serum insulin concentration (Cmax)
Secondary Outcomes (6)
Area under the serum insulin concentration-time curve (AUC 0-6 hours)
Area under the serum insulin concentration-time curve (AUC 6-24 hours)
Area under the serum insulin concentration-time curve (AUC 0-inifinity hours)
Time to maximum serum insulin concentration (tmax)
Terminal insulin half life (t½)
- +1 more secondary outcomes
Study Arms (2)
Formulation A
EXPERIMENTALFormulation B
ACTIVE COMPARATORInterventions
Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits
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, defined as no nicotine consumption for at least one year
- Fasting plasma glucose below or equal to 100 mg/dL (5.6 mmol/L)
You may not qualify if:
- Previous participation in this trial or other clinical trials within the last 3 months
- Body weight above 87.5 kg
- 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
- History of alcohol or drug abuse
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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2011
First Posted
December 7, 2011
Study Start
May 1, 2006
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
March 18, 2015
Record last verified: 2015-03