Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00505375
Status:
COMPLETED
Last Update Posted:
2020-05-06
First Post:
2007-07-20
Brief Title:
Intravenous CTLA4-lg Treatment in Recent Onset Type 1 Diabetes Mellitus
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Effects of CTLA-4 Ig Abatacept On The Progression of Type 1 Diabetes In New Onset Subjects
Status:
COMPLETED
Status Verified Date:
2020-04
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:
TN09
Brief Summary:
The purpose of this study is to determine whether treatment with CTLA4-Ig Abatacept in individuals with new onset T1DM will improve insulin secretion C-peptide production compared to placebo
Detailed Description:
Type 1 diabetes mellitus T1DM is a T-cell mediated autoimmune disease in which insulin-producing beta cells are completely or near completely destroyed resulting in life-long dependence on exogenous insulin
CTLA4-Ig Abatacept inhibits a crucial stimulatory pathway in the activation of T cells By this mechanism the drug is thought to arrest or slow the T cell mediated autoimmune destruction of beta-cells and preserve their function At the time of clinical onset of T1DM a significant amount of insulin producing beta cells are destroyed but as many as 10-20 are still capable of insulin production By using CTLA4-Ig close to the onset of T1DM we hope to arrest or slow down the autoimmune destruction of these beta-cells and extend the endogenous insulin production CTLA4-Ig regulates T cell function but does not deplete T cells Therefore its safety profile appears to be better than other immunosuppressive agents
Eligible participants will be randomized to the experimental or control groups The experimental group will receive intravenous infusions of CTLA-4 Ig The first infusion will occur at the time of randomization followed by another infusion 2 and 4 weeks later Subsequent infusions will be given monthly for two years during the treatment phase of the study There is a total of 27 infusions during the treatment phase of the study
Participants in the control group will receive intravenous infusions of placebo according to the same schedule outlined above
Both groups will receive standard intensive diabetes treatment with insulin and dietary management
All participants randomized into the study will be seen at study site monthly for 24 months and then every 6 months for up to an additional 2 years Participants will undergo assessments of their insulin production immunologic status overall health and well being and diabetes care
CTLA4-Ig Abatacept inhibits a crucial stimulatory pathway in the activation of T cells By this mechanism the drug is thought to arrest or slow the T cell mediated autoimmune destruction of beta-cells and preserve their function At the time of clinical onset of T1DM a significant amount of insulin producing beta cells are destroyed but as many as 10-20 are still capable of insulin production By using CTLA4-Ig close to the onset of T1DM we hope to arrest or slow down the autoimmune destruction of these beta-cells and extend the endogenous insulin production CTLA4-Ig regulates T cell function but does not deplete T cells Therefore its safety profile appears to be better than other immunosuppressive agents
Eligible participants will be randomized to the experimental or control groups The experimental group will receive intravenous infusions of CTLA-4 Ig The first infusion will occur at the time of randomization followed by another infusion 2 and 4 weeks later Subsequent infusions will be given monthly for two years during the treatment phase of the study There is a total of 27 infusions during the treatment phase of the study
Participants in the control group will receive intravenous infusions of placebo according to the same schedule outlined above
Both groups will receive standard intensive diabetes treatment with insulin and dietary management
All participants randomized into the study will be seen at study site monthly for 24 months and then every 6 months for up to an additional 2 years Participants will undergo assessments of their insulin production immunologic status overall health and well being and diabetes care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UC4DK097835 | NIH | None | httpsreporternihgovquickSearchUC4DK097835 |
| U01DK061055 | NIH | None | None |