Status:
COMPLETED
Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy Volunteers
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This trial is conducted in the United states of America (USA). The aim of this trial is to compare two formulations of biphasic insulin aspart 30 in healthy volunteers.
Eligibility Criteria
Inclusion
- BMI (body mass index) between 18 and 28 kg/m\^2, both inclusive
- Subject is a nonsmoker for at least 3 months
- Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data
- Fasting plasma glucose between 80 and 110 mg/dl
Exclusion
- •Any clinically significant disease history of systemic or organ disease
- •Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening (any abnormality should be discussed with the clinical monitor)
- •In females of child bearing potential: Pregnancy, lactating, breastfeeding, intent to become pregnant within the next 6-months or judged to be using inadequate contraceptive measures (adequate contraceptive measures include: condom, intrauterine devices). ß-hCG pregnancy test must be negative
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01487811
Start Date
May 1 2005
End Date
November 1 2005
Last Update
January 6 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78229