Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy Volunteers

Phase 1

Completed

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

• Registration Number: NCT01707160
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1995-11
• Primary Completion: 1995-12
• Study Completion: 1995-12
• Study First Submitted: 2012-10-10
• Study First Submitted QC: 2012-10-15
• Study First Posted: 2012-10-16
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-03
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment period 1	biphasic insulin aspart 30	-
Treatment period 1	biphasic human insulin 30	-
Treatment period 2	biphasic insulin aspart 30	-
Treatment period 2	biphasic human insulin 30	-

Primary Outcome Measures

Name	Time	Method
Area under the Curve

Secondary Outcome Measures

Name	Time	Method
Time to maximum insulin concentration (tmax)
Maximum insulin concentration (Cmax)
Adverse events
Minimum glucose concentration (Cmin(glu))
Time to minimum glucose concentration (tmin(glu))

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Leeds, United Kingdom