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Reversing Type 1 Diabetes After it is Established

2014-08-27 03:14:28 | BioPortfolio

Summary

The primary purpose of this study is to determine if giving the combination therapy consisting of Thymoglobulin® (ATG) and Neulasta® (GCSF) to patients with established Type 1 Diabetes (T1D) is safe and secondarily, if the ATG and GCSF will preserve insulin production.

Description

This is a randomized, placebo controlled, blinded phase I/II trial. Potential subjects will be screened via a 4 hour mixed meal tolerance test o assess residual beta cell (C-peptide) function. If the C-peptide level at any time is ≥ 0.1 pmol/ml, and the subject meets the additional inclusion and exclusion criteria, they will be eligible for randomization and enrollment. The study will be randomized 2:1 such that 17 subjects will receive active therapy and 8 will receive placebo. Subjects must receive Thymoglobulin®/ Neulasta® or placebo within 8 weeks of randomization. Thymoglobulin® (2.5mg/kg)/placebo will be given as 0.5 mg/kg IV on day 1 and 2 mg/kg on day 2. Six doses of Neulasta® (6mg/dose)/placebo will be given SC every 2 weeks, with the first dose given prior to discharge after the Thymoglobulin® infusion. Complete metabolic panel (CMP) and CBC will be done at the screening visit, just prior to study drug initiation, daily during the Thymoglobulin® infusion admission, and at follow up visits. Following discharge, daily phone calls will be made to the subjects during the first 5 days of therapy and weekly thereafter. In addition, weekly phone calls for the month following completion of therapy will be used to document adverse reactions.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Diabetes Mellitus, Type 1

Intervention

Anti-Thymocyte Globin plus pegylated GCSF, Placebo

Location

University of Florida
Gainesville
Florida
United States
32610-0296

Status

Recruiting

Source

University of Florida

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:28-0400

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Medical and Biotech [MESH] Definitions

Members of the beta-globin family. In humans, they are encoded in a gene cluster on CHROMOSOME 11. They include epsilon-globin, gamma-globin, delta-globin and beta-globin. There is also a pseudogene of beta (theta-beta) in the gene cluster. Adult HEMOGLOBIN is comprised of two ALPHA-GLOBIN chains and two beta-globin chains.

Members of the beta-globin family. In humans, two non-allelic types of gamma-globin - A gamma and G gamma are encoded in the beta-globin gene cluster on CHROMOSOME 11. Two gamma-globin chains combine with two ZETA-GLOBIN chains to form the embryonic hemoglobin Portland. Fetal HEMOGLOBIN F is formed from two gamma-globin chains combined with two ALPHA-GLOBIN chains.

A member of the alpha-globin family. In humans, zeta-globin is encoded in the alpha-globin gene cluster located on CHROMOSOME 16. Two zeta-globin chains combine with two EPSILON GLOBIN chains to form the embryonic HEMOGLOBIN Gower 1.

A member of the beta-globin family. In humans, delta-globin is encoded in the beta-globin gene cluster located on CHROMOSOME 11. Two delta-globin chains along with two alpha-globin chains form HEMOGLOBIN A2 which makes up about 3% of the HEMOGLOBIN in adults.

A member of the beta-globin family. In humans, epsilon-globin is encoded in the beta-globin gene cluster located on CHROMOSOME 11. Two epsilon-globin chains combine with two ZETA-GLOBIN chains to form the embryonic hemoglobin Gower I or two epsilon-globin chains combine with two ALPHA-2 GLOBIN chains to form the embryonic hemoglobin Gower II.

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