Safety and Efficacy of Biphasic Insulin Aspart 50 in Subjects With Type 2 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
biphasic insulin aspart 50
biphasic human insulin 50
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
BIAsp
BHI
Arm Description
Outcomes
Primary Outcome Measures
Glycosylated haemoglobin A1c (HbA1c)
Secondary Outcome Measures
Occurrence of adverse event(s)
Blood glucose
Incidence of hypoglycaemic episodes
Change from baseline in insulin antibodies
Insulin doses
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01650129
Brief Title
Safety and Efficacy of Biphasic Insulin Aspart 50 in Subjects With Type 2 Diabetes
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
December 13, 2000 (Actual)
Primary Completion Date
October 18, 2001 (Actual)
Study Completion Date
October 18, 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 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.
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 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIAsp
Arm Type
Experimental
Arm Title
BHI
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 50
Intervention Description
Administered subcutaneously (s.c., under the skin) twice daily for 24 weeks. Injected immediately before breakfast and dinner
Intervention Type
Drug
Intervention Name(s)
biphasic human insulin 50
Intervention Description
Administered subcutaneously (s.c., under the skin) twice daily for 24 weeks. Injected 30 minutes before breakfast and dinner
Primary Outcome Measure Information:
Title
Glycosylated haemoglobin A1c (HbA1c)
Secondary Outcome Measure Information:
Title
Occurrence of adverse event(s)
Title
Blood glucose
Title
Incidence of hypoglycaemic episodes
Title
Change from baseline in insulin antibodies
Title
Insulin doses
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Tokyo
ZIP/Postal Code
1000005
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Safety and Efficacy of Biphasic Insulin Aspart 50 in Subjects With Type 2 Diabetes
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