Status:
COMPLETED
Intervention to Preserve Beta-Cell Function in GAD Ab-Positive Diabetes
Lead Sponsor:
Tokyo Study Group
Conditions:
GAD Ab Positive Clinically Type 2 Diabetic Patients
Eligibility:
All Genders
Phase:
NA
Brief Summary
We tested the hypothesis that insulin therapy rather than sulfonylurea (SU) treatment has a preferable outcome to reverse or preserve beta cell function in the patients with diabetes that is called sl...
Detailed Description
In a multicenter, randomized, nonblinded clinical study, 4,089 non-insulin dependent diabetic patients were screened for glutamic acid decarboxylase autoantibodies (GADAb). Sixty GADAb-positive non-in...
Eligibility Criteria
Inclusion
- Subjects should use SU agents to obtain as a goal good glycemic control.
- Duration of diabetes within 5 years from the onset (or diagnosis).
Exclusion
- Subjects having history of hyperglycemia requiring insulin treatment and/or history of ketosis/ketoacidosis were excluded.
- Subjects with malignant diseases, systemic inflammatory diseases, renal or liver disorders or malabsorption were also excluded.
Key Trial Info
Start Date :
January 1 1996
Trial Type :
INTERVENTIONAL
End Date :
January 1 2005
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00232375
Start Date
January 1 1996
End Date
January 1 2005
Last Update
October 4 2005
Active Locations (1)
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1
University of Yamanashi
Tamaho, Yamanashi, Japan, 409-3898