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

Phase 1

Completed

• Conditions: Healthy; Diabetes
• Interventions: Drug: biphasic insulin aspart 30

• Registration Number: NCT01487811
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-06
• Study First Posted: 2011-12-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-05
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Formulation 1	biphasic insulin aspart 30	-
Formulation 2	biphasic insulin aspart 30	-

Primary Outcome Measures

Name	Time	Method
Area under the concentration curve (AUC) of the two formulations from time 0 hours to infinity
Maximum drug concentration of the two formulations (Cmax)

Secondary Outcome Measures

Name	Time	Method
Mean residence time (MRT)
Area under the concentration curve for insulin aspart from time 0 hours to 16 hours
Frequency of adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 San Antonio, Texas, United States