GAD Ab Positive Clinically Type 2 Diabetic Patients
Conditions
Keywords
SPIDDM, LADA, GAD antibody, Beta cell function, Insulin
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).
Interventions
DRUGInsulin
Sponsors
Tokyo Study Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint was insulin-dependency (IDDM: integrated C-peptide values [sigma C-peptide] <4 ng/ml). | — |
Countries
Japan
Outcome results
None listed