Overview

This trial is active, not recruiting.

Conditions diabetes, type 1 diabetes
Treatment alpha 1-antitrypsin (aat, aralast np)
Phase phase 1
Sponsor University of Colorado, Denver
Collaborator Omni Bio Pharmaceutical, Inc.
Start date October 2010
End date October 2015
Trial size 15 participants
Trial identifier NCT01319331, 09-0667

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Alpha-1 Antitrypsin (AAT, Aralast NP) as prescribed for study duration
alpha 1-antitrypsin (aat, aralast np) Alpha-1 Antitrypsin
Eligible subjects will be treated once a week for 8 weeks (8 total treatments).

Primary Outcomes

Measure
To assess participant safety & feasibility of study drug administration
time frame: Study duration is 2 years

Secondary Outcomes

Measure
To assess AAT treatment on the maintenance of c-peptide production
time frame: Stimulated c-peptide at year one and two.
Assess the effects of AAT on glycemic variability and A1c.
time frame: Continuous Glucose Monitoring at one and two years.

Eligibility Criteria

Male or female participants from 6 years up to 45 years old.

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

Additional Information

Official title The Effects of Open Label Alpha-1 Antitrypsin on the Progression of Type 1 Diabetes in Subjects With Detectable C-peptide
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.