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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
biphasic insulin aspart 30
biphasic insulin aspart 50
biphasic insulin aspart 70
insulin aspart
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Active Comparator

Arm Label

BIAsp 30

BIAsp 50

BIAsp 70

IAsp

Arm Description

Outcomes

Primary Outcome Measures

Area under the GIR (glucose infusion rate)-curves in the first two hours post-dosing

Secondary Outcome Measures

Maximum GIR value
Time to maximum GIR value
Area under the GIR-curves
Maximum drug concentration for insulin aspart (IAsp)
Time to maximum IAsp concentration
Area under the curve of the IAsp profiles
Minimum drug concentration in NEFA (Nonesterified fatty acids)
Time to minimum plasma concentration, NEFA
Area under the curve of the NEFA profiles
Adverse events
Hypoglycaemic episodes

Full Information

First Posted
February 15, 2012
Last Updated
January 5, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01536028
Brief Title
Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, 50, 70 and Insulin Aspart in Subjects With Type 1 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIAsp 30
Arm Type
Active Comparator
Arm Title
BIAsp 50
Arm Type
Experimental
Arm Title
BIAsp 70
Arm Type
Experimental
Arm Title
IAsp
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 30
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 50
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 70
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
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
Primary Outcome Measure Information:
Title
Area under the GIR (glucose infusion rate)-curves in the first two hours post-dosing
Secondary Outcome Measure Information:
Title
Maximum GIR value
Title
Time to maximum GIR value
Title
Area under the GIR-curves
Title
Maximum drug concentration for insulin aspart (IAsp)
Title
Time to maximum IAsp concentration
Title
Area under the curve of the IAsp profiles
Title
Minimum drug concentration in NEFA (Nonesterified fatty acids)
Title
Time to minimum plasma concentration, NEFA
Title
Area under the curve of the NEFA profiles
Title
Adverse events
Title
Hypoglycaemic episodes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Neuss
ZIP/Postal Code
41460
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
19049377
Citation
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: 10.1089/dia.2008.0019.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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