Intervention to Preserve Beta-Cell Function in GAD Ab-Positive Diabetes
- Conditions
- GAD Ab Positive Clinically Type 2 Diabetic Patients
- Registration Number
- NCT00232375
- Lead Sponsor
- Tokyo Study Group
- 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 slowly progressive insulin-dependent (type 1) diabetes (SPIDDM) or latent autoimmune diabetes in adult (LADA).
- 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-insulin requiring diabetic patients with duration of diabetes =/\<5 years were assigned to either the SU group (n = 30) or the Insulin group (n = 30). Serum C-peptide response to annual oral glucose tolerance tests were followed for 57 mean months. The primary endpoint was insulin-dependency (IDDM: integrated C-peptide values \[sigma C-peptide\] \<4 ng/ml).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- Subjects should use SU agents to obtain as a goal good glycemic control.
- Duration of diabetes within 5 years from the onset (or diagnosis).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary endpoint was insulin-dependency (IDDM: integrated C-peptide values [sigma C-peptide] <4 ng/ml).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Yamanashi
🇯🇵Tamaho, Yamanashi, Japan