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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
biphasic insulin aspart 30
biphasic insulin aspart 70
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

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

Sites / Locations

  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment period 1

Treatment period 2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Area under the curve 0-24 hours
Serum insulin
Apparent t½ (apparent elimination half life)
Cmax, maximum concentration
tmax, time to reach Cmax
Adverse events

Full Information

First Posted
January 31, 2012
Last Updated
January 4, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01524809
Brief Title
Pharmacokinetics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 Diabetes
Official Title
A Single-Centre, Randomised, Double-Blind, 2- Period Crossover Trial Investigating the Steady State Pharmacokinetics of Biphasic Insulin Aspart 30 and Biphasic Insulin Aspart 70 in Subjects With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
June 2001 (Actual)
Study Completion Date
June 2001 (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 investigate steady state pharmacokinetics of biphasic insulin aspart 30 and biphasic insulin aspart 70 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
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment period 1
Arm Type
Experimental
Arm Title
Treatment period 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 30
Intervention Description
Dose individually adjusted. Administrated subcutaneously (s.c., under the skin) three times a day for 15 days in each treatment period. A wash-out period of 2-8 weeks will take place between treatment periods.
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 70
Intervention Description
Dose individually adjusted. Administrated subcutaneously (s.c., under the skin) three times a day for 15 days in each treatment period. A wash-out period of 2-8 weeks will take place between treatment periods.
Primary Outcome Measure Information:
Title
Area under the serum insulin curve 6-14 hours after dinner at day 15
Secondary Outcome Measure Information:
Title
Area under the serum insulin curve 6-14 hours after dinner at day 1
Title
Area under the serum insulin curve 0-6 hours after dinner
Title
Area under the curve 0-24 hours
Title
Serum insulin
Title
Apparent t½ (apparent elimination half life)
Title
Cmax, maximum concentration
Title
tmax, time to reach Cmax
Title
Adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) 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
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
Århus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
15717874
Citation
Chen JW, Lauritzen T, Christiansen JJ, Jensen LH, Clausen WH, Christiansen JS. Pharmacokinetic profiles of biphasic insulin aspart 30/70 and 70/30 in patients with Type 1 diabetes: a randomized double-blinded crossover study. Diabet Med. 2005 Mar;22(3):273-7. doi: 10.1111/j.1464-5491.2004.01404.x.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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