MedTrace Logo

Polyclonal Anti-T-Lymphocyte Globulin (ATG) in Type 1 Diabetes

NCT00190502 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2007-01-09

No results posted yet for this study

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

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Polyclonal anti-T-cell antibodies

Sponsors & Collaborators

  • Ministry of Health, Czech Republic

    collaborator OTHER_GOV

  • Institute for Clinical and Experimental Medicine

    lead OTHER_GOV

Principal Investigators

  • Frantisek Saudek, MD. · Institute for Clinical and Experimental Medicine, Prague

Study Design

Allocation
RANDOMIZED
Purpose
ECT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-11-30
Completion
2007-12-31

Countries

  • Czechia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00190502 on ClinicalTrials.gov