Comparison of Two Biphasic Insulin Aspart Treatments in Subjects With Type 2 Diabetes
A Randomised, Double-blind, 4-week, Crossover Trial on Two Treatment Regimens With Biphasic Insulin Aspart 70 and 50 in Patients With Type 2 Diabetes
1 other identifier
interventional
16
1 country
1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to compare two different active treatment regimens of biphasic insulin aspart 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_3 diabetes
Started Mar 1999
Shorter than P25 for phase_3 diabetes
1 active site
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
March 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 1999
CompletedFirst Submitted
Initial submission to the registry
January 25, 2012
CompletedFirst Posted
Study publicly available on registry
January 30, 2012
CompletedJanuary 4, 2017
January 1, 2017
3 months
January 25, 2012
January 3, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Fasting serum glucose
Secondary Outcomes (4)
24-hour serum glucose profiles
24-hour insulin profiles
Incidence of hypoglycaemic episodes
Incidence of adverse events
Study Arms (2)
BIAsp 70
EXPERIMENTALBIAsp 70 + BIAsp 50
EXPERIMENTALInterventions
Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner
Administered subcutaneously (s.c., under the skin) at dinner
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- Duration of diabetes for longer than 12 months
- Body mass index (BMI) below 35.0 kg/m\^2
- HbA1c below 11.0 %
- Treatment with BHI (biphasic human insulin) 20 or 30 twice daily for at least three months and in the last month as sole anti-diabetic treatment (i.e., no additional oral hypoglycaemic medication or daily use of short-acting insulin supplement)
You may not qualify if:
- Current treatment with agents affecting glucose metabolism
- History of drug or alcohol dependence
- Impaired hepatic function
- Impaired renal function
- Cardiac disease
- Proliferative retinopathy
- Recurrent severe hypoglycaemia or advanced neuropathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Århus C, 8000, Denmark
Related Publications (1)
Ejskjaer N, Rasmussen M, Kamp N, Lindholm A, Christiansen JS. Comparison of thrice daily 'high' vs. 'medium' premixed insulin aspart with respect to evening and overnight glycaemic control in patients with type 2 diabetes. Diabetes Obes Metab. 2003 Nov;5(6):438-45. doi: 10.1046/j.1463-1326.2003.00299.x.
PMID: 14617230RESULT
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 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2012
First Posted
January 30, 2012
Study Start
March 1, 1999
Primary Completion
June 1, 1999
Study Completion
June 1, 1999
Last Updated
January 4, 2017
Record last verified: 2017-01