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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: biphasic insulin aspart 30

Study type: Interventional

Funder types: Industry

Identifiers

NCT01487811

BIASP-1669

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• •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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Formulation 1

Experimental group

Treatment:

Drug: biphasic insulin aspart 30

Formulation 2

Active Comparator group

Treatment:

Drug: biphasic insulin aspart 30