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
About this trial
This is an interventional treatment trial for Diabetes
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
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
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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