Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00515099
Status:
TERMINATED
Last Update Posted:
2017-05-11
First Post:
2007-08-10
Brief Title:
Study of Antithymocyte Globulin for Treatment of New-onset T1DM
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Effect of Antithymocyte Globulin on Preserving Beta Cell Function in New Onset Type 1 Diabetes Mellitus
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
START
Brief Summary:
Antithymocyte globulin eg Thymoglobulin is an antibody preparation that is commonly used to treat and prevent organ transplant rejection The START trial aims to determine whether antithymocyte globulin ATG treatment can halt the progression of newly diagnosed type 1 diabetes when given within 12 weeks of disease diagnosis
Detailed Description:
Type 1 diabetes mellitus T1DM is an autoimmune disease in which the immune system mistakenly attacks the insulin-producing beta cells in the pancreas Without these cells the body cannot maintain proper blood glucose levels in response to daily activities such as eating or exercise Generally at the time someone is diagnosed with T1DM not all of a persons beta cells have been destroyed - between 15-40 remain healthy and are still able to produce insulin Importantly even small amounts of naturally produced insulin can improve blood sugar control make daily management of diabetes less complicated and reduce the risk of long term complications Preserving the remaining precious beta cells is therefore the goal of the START trial
The medication being tested in the START trial is antithymocyte globulin eg Thymoglobulin a mixture of specialized proteins called antibodies ATG attaches itself to white blood cells known as T cells some of which are responsible for the immune systems attack on beta cells that occurs in T1DM ATG can change how T cells work and can eliminate a large proportion of the T cells from the bloodstream temporarily Treatment of new onset T1DM with ATG is therefore expected to alter the behavior of the T cells to halt their attack and also reduce T cell numbers so that new T cells that grow in their place will learn to accept the beta cells rather than attacking them
Following an initial screening appointment eligible participants will be randomly assigned to one of two groups the Experimental Group will receive the study treatment while the Control Group that will receive placebo Each participant has a 2 in 3 chance of being assigned to the treatment group and a 1 in 3 chance of being assigned to the placebo The START trial is a blinded study so neither participants nor study physicians will know to which group an individual has been assigned All participants will receive intensive diabetes management Participants in both groups will be admitted to the hospital for 5-8 days to receive infusions of either the study drug or placebo
The duration of the study is 2 years Participants will have 8 follow-up appointments in the first year and 4 visits in the second year Most of these visits will last 1- 2 hours A review of interval health a physical exam an assessment of diabetes control including recent 5 day insulin use and blood sugar eg glucose testing and blood collection for laboratory testing will occur at each visit Four of the visits will last about 5 hours during which participants will undergo mixed-meal tolerance testing MMTT This involves drinking a special drink similar to a milkshake and having blood specimens taken over a 4-hour period
Subjects will be reimbursed for travel and parking expenses and will receive compensation for their participation in the longer mixed meal tolerance test visits
The medication being tested in the START trial is antithymocyte globulin eg Thymoglobulin a mixture of specialized proteins called antibodies ATG attaches itself to white blood cells known as T cells some of which are responsible for the immune systems attack on beta cells that occurs in T1DM ATG can change how T cells work and can eliminate a large proportion of the T cells from the bloodstream temporarily Treatment of new onset T1DM with ATG is therefore expected to alter the behavior of the T cells to halt their attack and also reduce T cell numbers so that new T cells that grow in their place will learn to accept the beta cells rather than attacking them
Following an initial screening appointment eligible participants will be randomly assigned to one of two groups the Experimental Group will receive the study treatment while the Control Group that will receive placebo Each participant has a 2 in 3 chance of being assigned to the treatment group and a 1 in 3 chance of being assigned to the placebo The START trial is a blinded study so neither participants nor study physicians will know to which group an individual has been assigned All participants will receive intensive diabetes management Participants in both groups will be admitted to the hospital for 5-8 days to receive infusions of either the study drug or placebo
The duration of the study is 2 years Participants will have 8 follow-up appointments in the first year and 4 visits in the second year Most of these visits will last 1- 2 hours A review of interval health a physical exam an assessment of diabetes control including recent 5 day insulin use and blood sugar eg glucose testing and blood collection for laboratory testing will occur at each visit Four of the visits will last about 5 hours during which participants will undergo mixed-meal tolerance testing MMTT This involves drinking a special drink similar to a milkshake and having blood specimens taken over a 4-hour period
Subjects will be reimbursed for travel and parking expenses and will receive compensation for their participation in the longer mixed meal tolerance test visits
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