Comparison of Two Formulations of Biphasic Insulin Aspart 70

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: biphasic insulin aspart 70; Drug: biphasic insulin aspart 50

Study type: Interventional

Funder types: Industry

Identifiers

NCT01523041

BIASP-1144

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to compare two formulations of biphasic insulin aspart 70 and characterise the pharmacokinetics of biphasic insulin aspart 50 and biphasic insulin aspart 70 in healthy male subjects.

Full description

Each subject participated in three treatment periods, and were randomly assigned to each of the six treatment sequences in varying order

Enrollment: 24 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Caucasian
• Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
• Body mass index (BMI) between 19-27 kg/m^2
• Fasting plasma glucose between 3.8-6.0 mmol/L

Exclusion criteria

• Participation in any other clinical trial involving other investigational products within the last three months
• Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator
• Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 3 patient groups

BIAsp 70 clinical trial formulation

Experimental group

Treatment:

Drug: biphasic insulin aspart 70

Drug: biphasic insulin aspart 70

BIAsp 70 final formulation

Experimental group

Treatment:

Drug: biphasic insulin aspart 70

Drug: biphasic insulin aspart 70

BIAsp 50 final formulation

Experimental group

Treatment:

Drug: biphasic insulin aspart 50