Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes
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
1 other identifier
interventional
13
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 diabetes
Started Apr 1997
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 1997
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 1998
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 1998
CompletedFirst Submitted
Initial submission to the registry
September 28, 2012
CompletedFirst Posted
Study publicly available on registry
October 2, 2012
CompletedJanuary 4, 2017
January 1, 2017
1.6 years
September 28, 2012
January 3, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the serum insulin curve
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
BIAsp 30
EXPERIMENTALBHI 30
ACTIVE COMPARATORInterventions
Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs
Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs
Eligibility Criteria
You may qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (2)
Novo Nordisk Investigational Site
Alphen aan den Rijn, Netherlands
Novo Nordisk Investigational Site
Crawley, RH11 9RT, United Kingdom
Related Publications (1)
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.
PMID: 12017398RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR,1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2012
First Posted
October 2, 2012
Study Start
April 1, 1997
Primary Completion
November 1, 1998
Study Completion
November 1, 1998
Last Updated
January 4, 2017
Record last verified: 2017-01