Back to resultsGlycaemic Control of Biphasic Insulin Aspart 70 and 30 in Subjects With Type 2 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
biphasic insulin aspart 30
biphasic insulin aspart 70
biphasic human insulin 30
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Subjects with Type 2 diabetes
- Treatment with BHI (biphasic human insulin) 30 twice daily for at least three months
- HbA1c maximum 10.0%
- BMI (Body Mass Index) maximum 35.0 kg/m2
- Able and willing to perform self-blood glucose monitoring (SBGM)
Exclusion Criteria:
- The receipt of any investigational drug within the last 30 days prior to this trial
- Total daily insulin dose minimum 2.0 U/(kg·day)
- A history of drug abuse or alcohol dependence within the last 5 years
- Impaired hepatic function
- Impaired renal function
- Cardiac disease
- Severe, uncontrolled hypertension
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment period 1
Treatment period 2
Arm Description
Outcomes
Primary Outcome Measures
Glucose average in 24-hour blood glucose profiles
Secondary Outcome Measures
Pre-meal glucose level
Post-meal excursion of glucose (0-4 hours)
Cmax, maximum concentration of total insulin
tmax, time of maximum concentration of total insulin
The area under the 24-hour total insulin concentration time curve
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01526980
Brief Title
Glycaemic Control of Biphasic Insulin Aspart 70 and 30 in Subjects With Type 2 Diabetes
Official Title
A Single-Centre, Randomised, Open-Labelled, Two-Period, Crossover Trial In Subjects With Type 2 Diabetes Comparing the Glycaemic Control of Two Treatment Regimens: A Thrice Daily Regimen With Biphasic Insulin Aspart 70 and - 30 and a Twice Daily Regimen With Biphasic Human Insulin 30
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
November 2002 (Actual)
Study Completion Date
November 2002 (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 compare the glycaemic control of biphasic insulin aspart 70 + biphasic insulin aspart 30 with biphasic human insulin 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
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment period 1
Arm Type
Experimental
Arm Title
Treatment period 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 30
Intervention Description
Administrated subcutaneously (s.c., under the skin) once daily before dinner for 30 days in each treatment period
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 70
Intervention Description
Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and lunch for 30 days in each treatment period
Intervention Type
Drug
Intervention Name(s)
biphasic human insulin 30
Intervention Description
Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and dinner for 30 days in each treatment period
Primary Outcome Measure Information:
Title
Glucose average in 24-hour blood glucose profiles
Secondary Outcome Measure Information:
Title
Pre-meal glucose level
Title
Post-meal excursion of glucose (0-4 hours)
Title
Cmax, maximum concentration of total insulin
Title
tmax, time of maximum concentration of total insulin
Title
The area under the 24-hour total insulin concentration time curve
Title
Adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with Type 2 diabetes
Treatment with BHI (biphasic human insulin) 30 twice daily for at least three months
HbA1c maximum 10.0%
BMI (Body Mass Index) maximum 35.0 kg/m2
Able and willing to perform self-blood glucose monitoring (SBGM)
Exclusion Criteria:
The receipt of any investigational drug within the last 30 days prior to this trial
Total daily insulin dose minimum 2.0 U/(kg·day)
A history of drug abuse or alcohol dependence within the last 5 years
Impaired hepatic function
Impaired renal function
Cardiac disease
Severe, uncontrolled hypertension
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
Newcastle
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19527481
Citation
Dashora U, Ashwell SG, Home PD. An exploratory study of the effect of using high-mix biphasic insulin aspart in people with type 2 diabetes. Diabetes Obes Metab. 2009 Jul;11(7):680-7. doi: 10.1111/j.1463-1326.2008.01024.x.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Glycaemic Control of Biphasic Insulin Aspart 70 and 30 in Subjects With Type 2 Diabetes
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