Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, 50, 70 and Insulin Aspart in Subjects With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

A Double-blind, Randomised, Four-Period Crossover Trial Comparing the Pharmacodynamics and Pharmacokinetics After Single Dose of Biphasic Insulin Aspart 30, Biphasic Insulin Aspart 50, Biphasic Insulin Aspart 70 and Insulin Aspart in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536028
• Other study ID #: BIASP-1746
• Secondary ID: 2005-004965-40
• Status: Completed
• Phase: Phase 1
• First received: February 15, 2012
• Last updated: January 5, 2017
• Start date: April 2006
• Est. completion date: July 2006

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics and pharmacokinetics after a single dose of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in subjects with type 1 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes for at least 12 months

• Serum C-peptide maximum 0.4 ng/mL

• Current basal bolus treatment with soluble human insulin, insulin lispro, insulin glulisine, NPH insulin, insulin detemir or insulin glargine

• BMI (Body Mass Index) maximum 32 kg/m^2

• HbA1c (glycosylated haemoglobin) maximum 9% based on analysis from central laboratory

• Non-smoker

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

• Current treatment with IAsp (insulin aspart) products

• A history of drug or alcohol abuse within the last 5 years

• Impaired hepatic function

• Impaired renal function

• Cardiac problems

• Severe, uncontrolled hypertension

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• biphasic insulin aspart 30
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
• biphasic insulin aspart 50
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
• biphasic insulin aspart 70
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
• insulin aspart
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Heise T, Eckers U, Kanc K, Nielsen JN, Nosek L. The pharmacokinetic and pharmacodynamic properties of different formulations of biphasic insulin aspart: a randomized, glucose clamp, crossover study. Diabetes Technol Ther. 2008 Dec;10(6):479-85. doi: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the GIR (glucose infusion rate)-curves in the first two hours post-dosing			No
Secondary	Maximum GIR value			No
Secondary	Time to maximum GIR value			No
Secondary	Area under the GIR-curves			No
Secondary	Maximum drug concentration for insulin aspart (IAsp)			No
Secondary	Time to maximum IAsp concentration			No
Secondary	Area under the curve of the IAsp profiles			No
Secondary	Minimum drug concentration in NEFA (Nonesterified fatty acids)			No
Secondary	Time to minimum plasma concentration, NEFA			No
Secondary	Area under the curve of the NEFA profiles			No
Secondary	Adverse events			No
Secondary	Hypoglycaemic episodes			No

External Links

•   Clinical Trials at Novo Nordisk