Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes

Phase 2

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: biphasic insulin aspart 30; Drug: biphasic human insulin 30

• Registration Number: NCT01697618
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate pharmacokinetics, pharmacodynamics and safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-04
• Primary Completion: 1998-11
• Study Completion: 1998-11
• Study First Submitted: 2012-09-28
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-02
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-03
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Type 2 diabetes for at least 12 months
• Treated with a combination of soluble/protracted human insulin in the ratio of 30/70 in a twice-daily regimen for at least 6 months
• BMI (body mass index) below 39 kg/m^2
• HbA1c (glycosylated haemoglobin) below 12%

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BIAsp 30	biphasic insulin aspart 30	-
BIAsp 30	biphasic human insulin 30	-
BHI 30	biphasic insulin aspart 30	-
BHI 30	biphasic human insulin 30	-

Primary Outcome Measures

Name	Time	Method
Area under the serum insulin curve

Secondary Outcome Measures

Name	Time	Method
Overall shape of the 24 hour serum glucose profile
Serum glucose excursions (EXC)
Cmax (maximum plasma concentration)
tmax (time to reach maximum)
Overall shape of the 24 hour serum insulin profile
Area under the curve following each injections derived from 24 hours serum insulin profiles

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Crawley, United Kingdom