Back to resultsComparison of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With Metformin in Subjects With Type 2 Diabetes.
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
biphasic insulin aspart
insulin glargine
metformin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes Body mass index equal to or lesser than 35.0 kg/m2 Currently treated with oral hypoglycaemic drug Exclusion Criteria: Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator Any condition that the Investigator and/or the Sponsor feel would interfere with trial participation or evaluation of results
Sites / Locations
- Novo Nordisk Investigational Site
Outcomes
Primary Outcome Measures
HbA1c
Secondary Outcome Measures
safety variables
other glycemic variables
Fasting plasma glucose value
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00184626
Brief Title
Comparison of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With Metformin in Subjects With Type 2 Diabetes.
Official Title
Safety and Efficacy of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With Metformin in Subjects With Type 2 Diabetes.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 10, 2004 (Actual)
Primary Completion Date
October 24, 2005 (Actual)
Study Completion Date
October 24, 2005 (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. The aim of the trial is to compare the glycaemic control of Insulin glargine versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in combination with metformin 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 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Type
Drug
Intervention Name(s)
metformin
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
Measured at end of treatment (26 weeks)
Secondary Outcome Measure Information:
Title
safety variables
Title
other glycemic variables
Title
Fasting plasma glucose value
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes
Body mass index equal to or lesser than 35.0 kg/m2
Currently treated with oral hypoglycaemic drug
Exclusion Criteria:
Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator
Any condition that the Investigator and/or the Sponsor feel would interfere with trial participation or evaluation of results
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
Istanbul
ZIP/Postal Code
111
Country
Turkey
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Comparison of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With Metformin in Subjects With Type 2 Diabetes.
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