Comparison of Single Dose and Steady State Pharmacodynamics 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: NCT01526941
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare the single dose and steady state pharmacodynamics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects with type 1 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-05
• Primary Completion: 2001-07
• Study Completion: 2001-07
• Study First Submitted: 2012-02-01
• Study First Submitted QC: 2012-02-01
• Study First Posted: 2012-02-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-04
• Last Update Posted: 2017-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Type 1 diabetes for at least 12 months
• Currently on basal bolus treatment with soluble human insulin, Lispro and NPH insulin or Lantus. NPH insulin may be administered once or twice daily
• BMI (Body Mass Index) maximum 35 kg/m^2
• Able and willing to perform self-blood glucose monitoring

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Exclusion Criteria

• 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/day
• Currently being treated with insulin aspart products
• A history of drug abuse or alcohol dependence within the last 5 years
• Impaired hepatic function
• Impaired renal function
• Blood donation (exceeding 500 ml) within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory
• Cardiac problems
• Severe, uncontrolled hypertension

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Steady state area under the glucose infusion rate profile, 6-12 hours

Secondary Outcome Measures

Name	Time	Method
Time to 50% of area under the glucose infusion rate profile, 0-12 hours
tmax, time to reach Cmax
Adverse events
GIRmax, the maximal glucose infusion rate value
area under the glucose infusion rate profile
Cmax, maximum concentration
Area under the curve
tmax, time to maximum glucose infusion rate value
t½, terminal half-life

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany