Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00190502
Status:
UNKNOWN
Last Update Posted:
2007-01-09
First Post:
2005-09-11
Brief Title:
Polyclonal Anti-T-Lymphocyte Globulin ATG in Type 1 Diabetes
Sponsor:
Institute for Clinical and Experimental Medicine
Organization:
Institute for Clinical and Experimental Medicine
Study Overview
Official Title:
The Use of Polyclonal Anti-T-Lymphocyte Globulin to Prevent Progression of Autoimmune Beta-Cell Destruction in Recent Type 1 Diabetes
Status:
UNKNOWN
Status Verified Date:
2004-02
Last Known Status:
RECRUITING
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:
The primary objective of the study is
To compare the effect of ATG treatment together with intensified insulin therapy Group 1 on fasting and glucagon-stimulated C-peptide production with that of intensified insulin therapy only Group 2 in type 1 diabetes mellitus of recent onset
Secondary objectives are
To compare the insulin doses between the two groups at 6 12 18 and 24 months after diabetes onset
To compare the course of the specific humoral markers of autoimmunity between the groups
To evaluate the significance of in vitro testing of specific T-cell activation by an autoantigen in the long-term follow-up in type 1 diabetes
To assess the safety of ATG treatment in type 1 diabetes
To compare the effect of ATG treatment together with intensified insulin therapy Group 1 on fasting and glucagon-stimulated C-peptide production with that of intensified insulin therapy only Group 2 in type 1 diabetes mellitus of recent onset
Secondary objectives are
To compare the insulin doses between the two groups at 6 12 18 and 24 months after diabetes onset
To compare the course of the specific humoral markers of autoimmunity between the groups
To evaluate the significance of in vitro testing of specific T-cell activation by an autoantigen in the long-term follow-up in type 1 diabetes
To assess the safety of ATG treatment in type 1 diabetes
Detailed Description:
This is a randomized controlled single-blind and parallel group study After admission to the hospital initial physical and laboratory examinations will be performed Laboratory tests and medical treatment not related to the experimental protocol except for immunosuppressive drugs will be performed as clinically needed Patients who fulfill the inclusion criteria and give their informed consent to participate in the study will be randomized to be treated either with a course of ATG-Fresenius together with intensified insulin therapy Group 1 or with intensified insulin therapy only Group 2
For the study purpose clinical and laboratory status of the patients will be assessed at 14 occasions screening visit 1 - visit 14 Thereafter an extended follow-up study is planned with evaluations every 6 months
Patients will be referred to the research institution by cooperating general practitioners and diabetes specialists preferably before initiation of insulin therapy After diabetes confirmation according to WHO criteria and initial clinical and biochemical examinations typical for all patients with recent onset diabetes the purpose potential risk and benefits and the design of the study will be explained Subjects willing to participate in the study will be asked to give their written informed consent
All patients will be actively educated in diabetes management and intensified insulin therapy 3 - 4 daily injections of human insulin glucose self-monitoring will be initiated according to individual needs In subjects randomized to Group 1 4 doses of ATG Fresenius first dose of 9 mgkg of body weight then 3 consecutive doses of 3 mgkg will be administered intravenously over 4 hours Subjects in Group 2 will be treated with saline infusion 500 ml on the same days 1 hour before the first ATG administration a cutaneous tolerance test 02 ml of the final solution will be performed Approximately 10 days after admission the patients will be dismissed Besides scheduled ambulant visits all subjects will be followed-up as clinically needed In Paediatric patients age 15-18 years recommendations of a paediatric endocrinologist concerning diabetes management will be respected
After completion of the study each patients diabetes specialist will be acquainted with the course of the treatment so far and the patients will be treated according to individual needs They will be seen regularly once per year in the Department of Diabetes in IKEM for the next 3 years
Discontinuation of the study
Participation in the study may be at all times stopped according to the patients will Should this require the medical status of the patients the study may be interrupted based on the investigators decision during the period of ATG administration
Study population
Twenty four patients with type 1 diabetes mellitus of recent onset will be followed in the Institute for Clinical and Experimental Medicine in Prague Inclusion criteria will be
Type 1 diabetes mellitus of known duration up to 6 weeks
Men and women 15 - 35 years old body mass index up to 32 kgm2 exclusion of gravidity in women
Insulin dose up to 40 IU per day for no longer than 1 month
C-peptide level 03 pmolml 4 min following iv administration of 1 ml glucagon
No previous immunosuppressive therapy no concurrent severe infection granulocyte count 2 x 109l platelet count 120 x 109l
For the study purpose clinical and laboratory status of the patients will be assessed at 14 occasions screening visit 1 - visit 14 Thereafter an extended follow-up study is planned with evaluations every 6 months
Patients will be referred to the research institution by cooperating general practitioners and diabetes specialists preferably before initiation of insulin therapy After diabetes confirmation according to WHO criteria and initial clinical and biochemical examinations typical for all patients with recent onset diabetes the purpose potential risk and benefits and the design of the study will be explained Subjects willing to participate in the study will be asked to give their written informed consent
All patients will be actively educated in diabetes management and intensified insulin therapy 3 - 4 daily injections of human insulin glucose self-monitoring will be initiated according to individual needs In subjects randomized to Group 1 4 doses of ATG Fresenius first dose of 9 mgkg of body weight then 3 consecutive doses of 3 mgkg will be administered intravenously over 4 hours Subjects in Group 2 will be treated with saline infusion 500 ml on the same days 1 hour before the first ATG administration a cutaneous tolerance test 02 ml of the final solution will be performed Approximately 10 days after admission the patients will be dismissed Besides scheduled ambulant visits all subjects will be followed-up as clinically needed In Paediatric patients age 15-18 years recommendations of a paediatric endocrinologist concerning diabetes management will be respected
After completion of the study each patients diabetes specialist will be acquainted with the course of the treatment so far and the patients will be treated according to individual needs They will be seen regularly once per year in the Department of Diabetes in IKEM for the next 3 years
Discontinuation of the study
Participation in the study may be at all times stopped according to the patients will Should this require the medical status of the patients the study may be interrupted based on the investigators decision during the period of ATG administration
Study population
Twenty four patients with type 1 diabetes mellitus of recent onset will be followed in the Institute for Clinical and Experimental Medicine in Prague Inclusion criteria will be
Type 1 diabetes mellitus of known duration up to 6 weeks
Men and women 15 - 35 years old body mass index up to 32 kgm2 exclusion of gravidity in women
Insulin dose up to 40 IU per day for no longer than 1 month
C-peptide level 03 pmolml 4 min following iv administration of 1 ml glucagon
No previous immunosuppressive therapy no concurrent severe infection granulocyte count 2 x 109l platelet count 120 x 109l
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NB6541-3 IGA MZCR | None | None | None |