Back to resultsEfficacy and Safety of Insulin Aspart Versus Glibenclamide in Type 2 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
insulin aspart
glibenclamide
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes Diet therapy for at least 12 weeks, or diet therapy and oral hypoglycaemic agent(s) other than SU agents for at least 12 weeks No previous treatment with insulin and/or SU agents HbA1c between 7.5% and 10.0% Body Mass Index (BMI) below 30.0 kg/m2 Exclusion Criteria: Proliferative retinopathy or maculopathy requiring acute treatment Impaired hepatic function Impaired renal function Cardiac diseases Uncontrolled hypertension Known hypoglycaemia unawareness or recurrent major hypoglycaemia Current treatment with systemic corticosteroids
Sites / Locations
Outcomes
Primary Outcome Measures
HbA1c
Secondary Outcome Measures
Plasma glucose levels
Percentage of subjects achieving the treatment target of HbA1c value < 6.5%
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00267683
Brief Title
Efficacy and Safety of Insulin Aspart Versus Glibenclamide in Type 2 Diabetes
Official Title
A Clinical Trial to Study the Efficacy and Safety of Insulin Aspart Three Times Per Day Compared to Glibenclamide Once or Twice Daily in Type 2 Diabetes by Comparison of Ability to Control Blood Glucose
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
This trial was terminated due to low recruitment
Study Start Date
December 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (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. This is a clinical trial to study the efficacy and safety of thrice daily Insulin Aspart compared to Glibenclamide in type 2 diabetic patients.
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
9 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Type
Drug
Intervention Name(s)
glibenclamide
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
after 24 weeks of treatment
Secondary Outcome Measure Information:
Title
Plasma glucose levels
Title
Percentage of subjects achieving the treatment target of HbA1c value < 6.5%
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes
Diet therapy for at least 12 weeks, or diet therapy and oral hypoglycaemic agent(s) other than SU agents for at least 12 weeks
No previous treatment with insulin and/or SU agents
HbA1c between 7.5% and 10.0%
Body Mass Index (BMI) below 30.0 kg/m2
Exclusion Criteria:
Proliferative retinopathy or maculopathy requiring acute treatment
Impaired hepatic function
Impaired renal function
Cardiac diseases
Uncontrolled hypertension
Known hypoglycaemia unawareness or recurrent major hypoglycaemia
Current treatment with systemic corticosteroids
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
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Efficacy and Safety of Insulin Aspart Versus Glibenclamide in Type 2 Diabetes
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