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The Effects of Alpha-1 Antitrypsin (AAT) on the Progression of Type 1 Diabetes

Information source: University of Colorado, Denver
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes; Type 1 Diabetes

Intervention: Alpha 1-Antitrypsin (AAT, Aralast NP) (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: University of Colorado, Denver

Overall contact:
Lisa Meyers, Phone: 303-724-6893, Email: lisa.meyers@ucdenver.edu

Summary

The purpose of this study is to determine if the drug Alpha-1 Antitrypsin (AAT, Aralast NP) will preserve beta-cell function and help slow the progression of type 1 diabetes.

Clinical Details

Official title: The Effects of Open Label Alpha-1 Antitrypsin on the Progression of Type 1 Diabetes in Subjects With Detectable C-peptide

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To assess participant safety & feasibility of study drug administration

Secondary outcome:

To assess AAT treatment on the maintenance of c-peptide production

Assess the effects of AAT on glycemic variability and A1c.

Eligibility

Minimum age: 6 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of Type 1 Diabetes Mellitus based on ADA Criteria for fewer than 5 years

but more than 100 days

- 6-45 years of age, inclusive. To assess safety, we will initially enroll 8 patients

over the age of 16. Following the last infusion of the 8th patient, we will assess adverse events. As long as there are no stopping criteria met for these 8 patients we will decrease the age criteria down to 6 years old.

- C-peptide increase during screening mixed meal tolerance test with a minimal

stimulated value of ≥ 0. 2 pmol/mL.

- Positive for antibodies to insulin (if insulin autoantibody positive only,

determination must be within two weeks of insulin initiation), GAD-65, IA-2 or ZnT8

- Agree to intensive management of diabetes with an HgbA1c goal of < 7. 0%

- If female, (a) surgically sterile or (b) postmenopausal or (c) if of reproductive

potential, willing to use medically acceptable birth control (e. g. female hormonal contraception, barrier methods or sterilization. ) until 3 months after completion of any treatment period

- If male and of reproductive potential, willing to use medically acceptable birth

control until 3 months after completion of any treatment period, unless the female partner is postmenopausal or surgically sterile

- Serum creatinine ≤ 1. 5 x upper limit of normal

- AST < 2 times the upper limit of normal

- Hematology: WBC > 3000 x 109/L; platelets > 100 x 109/L; hemoglobin > 10. 0 g/dL.

Exclusion Criteria:

- Unable or unwilling to comply with the requirements of the study protocol

- Body Mass Index (BMI) > 30 kg/m2

- Unstable blood sugar control defined as one or more episodes of severe hypoglycemia

(defined as hypoglycemia that required the assistance of another person) within the last 30 days

- Previous immunotherapy for T1D

- Administration of an experimental agent for T1D at any time or use of an experimental

device for T1D within 30 days of screening, unless approved by the study PI

- History of any organ transplant, including islet cell transplant

- Active autoimmune or immune deficiency disorder (e. g. sarcoidosis, rheumatoid

arthritis)

- Serum bilirubin > ULN, except those subjects whose abnormal values were attributed to

any stable, benign condition (such as Gilbert's Syndrome) may be included

- TSH outside the normal range at screening, except those subjects on stable doses of

thyroid hormone replacement therapy may be included

- Known HIV positivity, active hepatitis B or active hepatitis C infection

- Anticipated pregnancy during active dosing or within 3 months after completion of

active dosing phase

- History of a malignant neoplasm within the previous 5 years (except in situ cervical

cancer and curable non-melanoma skin malignancy)

- Any social condition or medical condition that would, in the opinion of the

investigator, prevent complete participation in the study or that would pose a significant hazard to the subjects' participation

- History of active substance abuse within 12 months of screening

- A psychiatric or medical disorder that would prevent giving informed consent

- Individuals with a history of IgA deficiency

- Individuals with a history of hypersensitivity to AAT

Locations and Contacts

Lisa Meyers, Phone: 303-724-6893, Email: lisa.meyers@ucdenver.edu

Barbara Davis Center for Childhood Diabetes, Aurora, Colorado 80045, United States; Recruiting
Dominic DiDomenico, Phone: 303-724-5687, Email: dominic.didomenico@ucdenver.edu
Peter A Gottlieb, MD, Principal Investigator
Aaron Michels, MD, Sub-Investigator
Additional Information

Starting date: October 2010
Last updated: January 7, 2013

Page last updated: February 07, 2013

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