Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy Volunteers

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: biphasic human insulin 30; Drug: biphasic insulin aspart 30

Study type: Interventional

Funder types: Industry

Identifiers

NCT01707160

ANA/DCD/031

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics and pharmacodynamics of insulin X14 30/70 PreMix compared to human insulin 30/70 PreMix in healthy volunteers.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Non-smokers
• BMI (body mass index) maximum 27 kg/m^2
• HbA1c (glycosylated haemoglobin A1c): 3.4-6.1%
• FBG (fasting blood glucose) maximum 6.0 mmol/L

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Treatment period 1

Experimental group

Treatment:

Drug: biphasic insulin aspart 30

Drug: biphasic human insulin 30

Treatment period 2

Active Comparator group

Treatment:

Drug: biphasic insulin aspart 30

Drug: biphasic human insulin 30