Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058981
Status:
TERMINATED
Last Update Posted:
2009-03-19
First Post:
2003-04-15
Brief Title:
Safety Tolerability Immunological and Clinical Efficacy of Multiple Subcutaneous Doses of DiaPep277 in Latent Autoimmune Diabetes in Adults LADA
Sponsor:
DeveloGen Israel Ltd
Organization:
DeveloGen Israel Ltd
Study Overview
Official Title:
Randomized Double-Blind Placebo-Controlled Parallel-Group Study to Investigate the Safety and Tolerability as Well as the Immunological and Clinical Efficacy of Multiple Subcutaneous Doses of DiaPep277 in LADA Subjects
Status:
TERMINATED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Randomized double-blind parallel-group study to evaluate safety and efficacy of multiple subcutaneous doses of DiaPep277 in patients with Latent Autoimmune Diabetes in Adults LADA Study medication will be administered at time 0 1 and 3 months and then every 3 months for a total of 8 administrations The total duration of the trial is 24 months treatment for 18 months and follow-up for an additional 6 months Patients will be male or female between the ages of 30 and 65 years inclusive within 2 to 60 months of the diagnosis of diabetes mellitus Subjects must be positive for glutamic acid decarboxylate GAD autoantibodies At the Screen Visit Visit 2 all subjects will be asked to discontinue their use of all oral antidiabetic medications with the exception of metformin The subjects will be placed on a stable regimen of insulin and diet plus metformin if needed Prior to the Baseline Visit Visit 3 diabetic control must be achieved by diet and insulin plus metformin if needed
Detailed Description:
None
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