Status:
COMPLETED
Comparison of Biphasic Insulin Aspart (30, 50 and 70) and Insulin Aspart in Healthy Subjects
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Healthy
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to demonstrate a difference between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic insulin aspart 50, bip...
Eligibility Criteria
Inclusion
- Body mass index between 18 and 28 kg/m\^2 inclusive
- HbA1c within the normal laboratory range
- Non smoker for at least three months
- Females of childbearing potential using acceptable methods of contraception, including tubal ligation, an intrauterine device (IUD) , the oral contraceptive pill or barrier methods
Exclusion
- Subjects who have received any investigational drug in the 3 months prior to the start of dosing
- Any disease requiring regular use of non topical prescription medicines
- Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug
- Any intercurrent illness or endocrine disorders that may affect blood glucose
- Subject with a history of drug or alcohol dependence
- Subject with a first degree relative with diabetes mellitus
- Subject with a history of clinically relevant allergic reactions to medical products
- Subjects who have donated any blood or plasma in the past 3 month preceding screening
Key Trial Info
Start Date :
April 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2000
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01520831
Start Date
April 1 1999
End Date
May 1 2000
Last Update
January 4 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Neuss, Germany, 41460