Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232375
Status:
COMPLETED
Last Update Posted:
2005-10-04
First Post:
2005-09-29
Brief Title:
Intervention to Preserve Beta-Cell Function in GAD Ab-Positive Diabetes
Sponsor:
Tokyo Study Group
Organization:
Tokyo Study Group
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 4089 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 ngml
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None