Polyclonal Anti-T-Lymphocyte Globulin (ATG) in Type 1 Diabetes
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ClinicalTrials.gov Identifier: NCT00190502 |
Recruitment Status
: Unknown
Verified February 2004 by Institute for Clinical and Experimental Medicine.
Recruitment status was: Recruiting
First Posted
: September 19, 2005
Last Update Posted
: January 9, 2007
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 1 | Drug: Polyclonal anti-T-cell antibodies | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Enrollment : | 28 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single |
Primary Purpose: | Educational/Counseling/Training |
Official Title: | The Use of Polyclonal Anti-T-Lymphocyte Globulin to Prevent Progression of Autoimmune Beta-Cell Destruction in Recent Type 1 Diabetes |
Study Start Date : | November 2000 |
Study Completion Date : | December 2007 |

- C-peptide production
- Diabetes remission rate
- Insulin dose

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Ages Eligible for Study: | 15 Years to 35 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Type 1 diabetes
- Body mass index up to 32 kg/m2
- Exclusion of gravidity in women
- 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
Exclusion Criteria:
- Other non-diabetes related autoimmune disease
- Previous immunosuppressive therapy
- Any clinical impairment precluding immunosuppressive therapy
- Leucopenia or thrombocytopenia

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00190502
Contact: Frantisek Saudek, MD. | frsa@medicon.cz |
Czech Republic | |
Institute for Clinical and Experimental Medicine, Department of Diabetes | Recruiting |
Prague, Czech Republic, 14021 | |
Contact: Frantisek Saudek, MD. frsa@medicon.cz | |
Principal Investigator: Frantisek Saudek, MD | |
Sub-Investigator: Petr Boucek, MD. | |
Sub-Investigator: Tereza Havrdova |
Study Chair: | Frantisek Saudek, MD. | Institute for Clinical and Experimental Medicine, Prague |
Publications of Results:
ClinicalTrials.gov Identifier: | NCT00190502 History of Changes |
Other Study ID Numbers: |
KD CD IKEM 1 NB/6541-3 IGA MZCR |
First Posted: | September 19, 2005 Key Record Dates |
Last Update Posted: | January 9, 2007 |
Last Verified: | February 2004 |
Keywords provided by Institute for Clinical and Experimental Medicine:
Type 1 diabetes mellitus Immune intervention Polyclonal antibodies |
Type 1 diabetes of recent onset C-peptide level 0.3 pmol/l or higher Positivity of at least one marker of autoimmunity (diabetes) |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Antibodies Immunoglobulins Immunologic Factors Physiological Effects of Drugs |