Comparison of Two Insulin Aspart Formulations in Healthy Volunteers
A Single Centre, Randomized, Balanced Double-blind, Cross-Over Trial Investigating the Bioequivalence of a Continuous Subcutaneous Infusion of a Marketed NovoRapid Formulation Containing 100 U/ml and a New NovoRapid Formulation Containing 200 U/ml in Healthy Male Volunteers
1 other identifier
interventional
24
1 country
1
Brief Summary
This trial is conducted in Africa. The aim of this trial is to determine if a new formulation (U200) of insulin aspart containing 200 U/mL is bioequivalent to that of a marketed insulin aspart formulation (U100).
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 Sep 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
September 2, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2002
CompletedFirst Submitted
Initial submission to the registry
September 28, 2012
CompletedFirst Posted
Study publicly available on registry
October 3, 2012
CompletedMarch 1, 2017
February 1, 2017
2 months
September 28, 2012
February 28, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Area under the curve (AUC)
Area under the glucose infusion rate curve
Secondary Outcomes (6)
Cmax (maximum plasma concentration)
Time to reach maximum (tmax)
Terminal half-life (t½)
Incidence of hypoglycemic events
Adverse events
- +1 more secondary outcomes
Study Arms (2)
U100
ACTIVE COMPARATORU200
EXPERIMENTALInterventions
Bolus 0.1 U/kg administered simultaneously with a continuous infusion of 0.029 U/kg/h via a programmed insulin pump. A total dose of 0.35 U/kg is delivered to the subject in the 12 hour infusion
Eligibility Criteria
You may qualify if:
- Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
- Normal laboratory values, electrocardiogram (ECG), and vital signs unless the investigator considers any abnormality to be clinically irrelevant
- Body mass index (BMI) 18-26 kg/m\^2 (both inclusive)
- Weight 60-90 kg
- Non-smoker
You may not qualify if:
- Any condition requiring the regular use of any medication
- Known or suspected allergy to the trial product or related products
- Family history of type 1 diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Bloemfontein, 9324, South Africa
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
September 28, 2012
First Posted
October 3, 2012
Study Start
September 2, 2002
Primary Completion
October 18, 2002
Study Completion
October 18, 2002
Last Updated
March 1, 2017
Record last verified: 2017-02