Polyclonal Anti-T-Lymphocyte Globulin (ATG) in Type 1 Diabetes
The Use of Polyclonal Anti-T-Lymphocyte Globulin to Prevent Progression of Autoimmune Beta-Cell Destruction in Recent Type 1 Diabetes
2 other identifiers
interventional
28
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2000
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 11, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedJanuary 9, 2007
February 1, 2004
September 11, 2005
January 8, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
C-peptide production
Secondary Outcomes (2)
Diabetes remission rate
Insulin dose
Interventions
Eligibility Criteria
You may qualify if:
- Type 1 diabetes
- Body mass index up to 32 kg/m2
- Known diagnosis of diabetes of less than 6 weeks
- Insulin dose of up to 40 IU per day for no longer than 1 month
- Positive for at least one autoantibody (GAD, IA2, ICA)
- C-peptide level ≥ 0.3 pmol/ml 4 min. following intravenous (IV) administration of 1 ml glucagon
- No concurrent severe infection
- Granulocyte count ≥ 2 x 10\^9/l
- Platelet count ≥ 120 x 10\^9/l
You may not qualify if:
- Other non-diabetes related autoimmune disease
- Previous immunosuppressive therapy
- Any clinical impairment precluding immunosuppressive therapy
- Leucopenia or thrombocytopenia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute for Clinical and Experimental Medicine, Department of Diabetes
Prague, 14021, Czechia
Related Publications (1)
Saudek F, Havrdova T, Boucek P, Karasova L, Novota P, Skibova J. Polyclonal anti-T-cell therapy for type 1 diabetes mellitus of recent onset. Rev Diabet Stud. 2004 Summer;1(2):80-8. doi: 10.1900/RDS.2004.1.80. Epub 2004 Aug 10.
PMID: 17491669RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Frantisek Saudek, MD.
Institute for Clinical and Experimental Medicine, Prague
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- ECT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
September 11, 2005
First Posted
September 19, 2005
Study Start
November 1, 2000
Study Completion
December 1, 2007
Last Updated
January 9, 2007
Record last verified: 2004-02