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Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
biphasic insulin aspart 30
biphasic human insulin 30
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

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 2 diabetes for at least 12 months
  • Treated with a combination of soluble/protracted human insulin in the ratio of 30/70 in a twice-daily regimen for at least 6 months
  • BMI (body mass index) below 39 kg/m^2
  • HbA1c (glycosylated haemoglobin) below 12%

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BIAsp 30

BHI 30

Arm Description

Outcomes

Primary Outcome Measures

Area under the serum insulin curve

Secondary Outcome Measures

Overall shape of the 24 hour serum insulin profile
Cmax (maximum plasma concentration)
tmax (time to reach maximum)
Area under the curve following each injections derived from 24 hours serum insulin profiles
Overall shape of the 24 hour serum glucose profile
Serum glucose excursions (EXC)

Full Information

First Posted
September 28, 2012
Last Updated
January 3, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01697618
Brief Title
Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes
Official Title
A Randomised, Double-blind, Single Centre, Two-way Cross-over Trial Comparing the Pharmacokinetics, Pharmacodynamics and Safety of the Biphasic Insulin Aspart 30 and Insulin Mixtard 30/70 After Multiple Dosing With a Twice Daily Dose Regimen in Type 2 Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 1997 (undefined)
Primary Completion Date
November 1998 (Actual)
Study Completion Date
November 1998 (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 pharmacokinetics, pharmacodynamics and safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIAsp 30
Arm Type
Experimental
Arm Title
BHI 30
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 30
Intervention Description
Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs
Intervention Type
Drug
Intervention Name(s)
biphasic human insulin 30
Intervention Description
Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs
Primary Outcome Measure Information:
Title
Area under the serum insulin curve
Secondary Outcome Measure Information:
Title
Overall shape of the 24 hour serum insulin profile
Title
Cmax (maximum plasma concentration)
Title
tmax (time to reach maximum)
Title
Area under the curve following each injections derived from 24 hours serum insulin profiles
Title
Overall shape of the 24 hour serum glucose profile
Title
Serum glucose excursions (EXC)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes for at least 12 months Treated with a combination of soluble/protracted human insulin in the ratio of 30/70 in a twice-daily regimen for at least 6 months BMI (body mass index) below 39 kg/m^2 HbA1c (glycosylated haemoglobin) below 12%
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
Alphen a/d Rijn
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Crawley
ZIP/Postal Code
RH11 9RT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
12017398
Citation
McSorley PT, Bell PM, Jacobsen LV, Kristensen A, Lindholm A. Twice-daily biphasic insulin aspart 30 versus biphasic human insulin 30: a double-blind crossover study in adults with type 2 diabetes mellitus. Clin Ther. 2002 Apr;24(4):530-9. doi: 10.1016/s0149-2918(02)85129-3.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes

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