Pharmacokinetics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 Diabetes

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: biphasic insulin aspart 30; Drug: biphasic insulin aspart 70

• Registration Number: NCT01524809
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate steady state pharmacokinetics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects with type 1 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2001-06
• Study Completion: 2001-06
• Study First Submitted: 2012-01-31
• Study First Submitted QC: 2012-01-31
• Study First Posted: 2012-02-02
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-04
• Last Update Posted: 2017-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Type 1 diabetes for at least 12 months
• Currently on a multiple dose insulin regimen
• HbA1c maximum 12.0%
• BMI (body mass index) below 35 kg/m^2
• Able and willing to perform self-blood glucose monitoring (SBGM)

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Exclusion Criteria

• Treatment with insulin aspart within the last 14 days prior to this trial
• The receipt of any investigational drug within the last 30 days prior to this trial
• Total daily insulin dose at least 1.8 U/kg
• A history of drug abuse or alcohol dependence within the last 5 years
• Impaired hepatic function
• Impaired renal function
• Blood donation within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory
• Cardiac disease
• Severe, uncontrolled hypertension

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment period 1	biphasic insulin aspart 30	-
Treatment period 1	biphasic insulin aspart 70	-
Treatment period 2	biphasic insulin aspart 70	-
Treatment period 2	biphasic insulin aspart 30	-

Primary Outcome Measures

Name	Time	Method
Area under the serum insulin curve 6-14 hours after dinner at day 15

Secondary Outcome Measures

Name	Time	Method
Adverse events
Area under the curve 0-24 hours
Serum insulin
Apparent t½ (apparent elimination half life)
Cmax, maximum concentration
tmax, time to reach Cmax
Area under the serum insulin curve 6-14 hours after dinner at day 1
Area under the serum insulin curve 0-6 hours after dinner

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇰 Århus C, Denmark