Safety and Efficacy of Biphasic Insulin Aspart 50 in Subjects With Type 2 Diabetes
An Open-labelled, Randomised, Parallel Group, Multicentre, Safety and Efficacy Study of NN-X14Mix50 (BIAsp50) in a Twice Daily Regimen in Type 2 Diabetic Subjects
1 other identifier
interventional
83
1 country
1
Brief Summary
This trial is conducted in Japan. The aim of this trial is to investigate the safety and efficacy of biphasic insulin aspart (BIAsp) 50 (NN-X14Mix50) compared with biphasic human insulin (BHI) 50 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 Dec 2000
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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 13, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2001
CompletedFirst Submitted
Initial submission to the registry
July 24, 2012
CompletedFirst Posted
Study publicly available on registry
July 26, 2012
CompletedFebruary 24, 2017
February 1, 2017
10 months
July 24, 2012
February 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Glycosylated haemoglobin A1c (HbA1c)
Secondary Outcomes (5)
Occurrence of adverse event(s)
Blood glucose
Incidence of hypoglycaemic episodes
Change from baseline in insulin antibodies
Insulin doses
Study Arms (2)
BIAsp
EXPERIMENTALBHI
EXPERIMENTALInterventions
Administered subcutaneously (s.c., under the skin) twice daily for 24 weeks. Injected immediately before breakfast and dinner
Administered subcutaneously (s.c., under the skin) twice daily for 24 weeks. Injected 30 minutes before breakfast and dinner
Eligibility Criteria
You may qualify if:
- Subjects with type 2 diabetes
- Subjects with insulin treated for at least 24 weeks
- HbA1c maximum 11.0%
- Body mass index (BMI) below 30.0 kg/m\^2
- Patients who have the skill of self-injection of insulin, and are able and willing to perform self-monitoring blood glucose (SMBG) and are able to take measures against hypoglycaemic episodes
You may not qualify if:
- Recurrent severe hypoglycaemia
- Subjects with proliferative retinopathy or preproliferative retinopathy diagnosed within the last 12 weeks, or receiving photocoagulation therapy within the last one year
- Impaired hepatic function
- Impaired renal function
- Cardiac diseases
- Uncontrolled hypertension
- Subjects with history of severe allergic or severe hypersensitive reactions
- Total daily insulin dose at least 100 IU
- Treatment with oral hypoglycaemic agentsvwithin the last 4 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Tokyo, 1000005, Japan
Related Links
MeSH Terms
Conditions
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
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2012
First Posted
July 26, 2012
Study Start
December 13, 2000
Primary Completion
October 18, 2001
Study Completion
October 18, 2001
Last Updated
February 24, 2017
Record last verified: 2017-02