Back to resultsSafety and Efficacy of Biphasic Human Insulin Compared to EX1000 in Type 2 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
EX1000
biphasic human insulin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes for at least 12 months
- Current biphasic human insulin (BHI) for at least 3 months - as monotherapy or as the only insulin in combination with OADs
- Body Mass Index (BMI) less than or equal to 40.0 kg/m2
- HbA1c less than or equal to 9.5%
- FPG (SMPG) less than or equal to 12 mmol/L
Exclusion Criteria:
- Treatment with more than 1IU/kg insulin daily
- Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
- Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
- Known or suspected allergy to trial products or related products
- Receipt of any investigational drug within one month prior to this trial
- Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
HbA1c
Secondary Outcome Measures
HbA1c
Fructosamine
FPG
4-point SMPG profiles
Incidence of hypoglycaemic episodes
Frequency and severity of adverse events (including injection site reactions)
Laboratory safety parameters (haematology, biochemistry and lipids)
Physical examination and vital signs
Total daily insulin dosages
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00698802
Brief Title
Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in Type 2 Diabetes
Official Title
Assessment of Safety and Efficacy of Biphasic Human Insulin IU 100 to EX1000 on Glycaemic Control in Subjects With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (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 Asia and Africa. This trial aims for a comparison of blood glucose control of biphasic human insulin 100 IU/mL and EX1000.
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
397 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
EX1000
Intervention Description
Treat-to-target titration scheme, s.c. injection
Intervention Type
Drug
Intervention Name(s)
biphasic human insulin
Intervention Description
Treat-to-target titration scheme, s.c. injection
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
after 8 weeks of treatment
Secondary Outcome Measure Information:
Title
HbA1c
Time Frame
For the duration of the trial
Title
Fructosamine
Time Frame
For the duration of the trial
Title
FPG
Time Frame
For the duration of the trial
Title
4-point SMPG profiles
Time Frame
For the duration of the trial
Title
Incidence of hypoglycaemic episodes
Time Frame
For the duration of the trial
Title
Frequency and severity of adverse events (including injection site reactions)
Time Frame
For the duration of the trial
Title
Laboratory safety parameters (haematology, biochemistry and lipids)
Time Frame
For the duration of the trial
Title
Physical examination and vital signs
Time Frame
For the duration of the trial
Title
Total daily insulin dosages
Time Frame
For the duration of the trial
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes for at least 12 months
Current biphasic human insulin (BHI) for at least 3 months - as monotherapy or as the only insulin in combination with OADs
Body Mass Index (BMI) less than or equal to 40.0 kg/m2
HbA1c less than or equal to 9.5%
FPG (SMPG) less than or equal to 12 mmol/L
Exclusion Criteria:
Treatment with more than 1IU/kg insulin daily
Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
Known or suspected allergy to trial products or related products
Receipt of any investigational drug within one month prior to this trial
Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers
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:
City
Vijayawada
ZIP/Postal Code
520002
Country
India
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
City
Abu Dhabi
ZIP/Postal Code
51900
Country
United Arab Emirates
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 Human Insulin Compared to EX1000 in Type 2 Diabetes
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