Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy Volunteers

Completed · Phase 1

Conditions studied: Diabetes, Healthy

In brief

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.

Key facts

Study ID

NCT01487811

Run by

Novo Nordisk A/S

People needed

50

Starts

2005-05-01

Expected to finish

2005-11-01

Last updated by the study team

2017-01-06

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• •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

Where it is running

• Novo Nordisk Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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