Overview

This trial is active, not recruiting.

Condition new onset type-1 diabetes
Treatments alpha-1 antitrypsin, placebo
Phase phase 2
Sponsor Kamada, Ltd.
Start date April 2014
End date January 2017
Trial size 71 participants
Trial identifier NCT02005848, Kamada-AAT(IV)-011

Summary

A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Study Evaluating the Efficacy and Safety of Human, Alpha-1 Antitrypsin (AAT) [Glassia®] in the Treatment of New Onset Type-1 Diabetes.

The study objectives are:

- To assess the efficacy of intravenous AAT in treatment of new onset Type 1 Diabetes

- To assess the safety and tolerability of intravenous AAT in new onset Type 1 Diabetes pediatric and young adult population.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
60 mg/kg body weight
alpha-1 antitrypsin Humman Alpha-1 Antitrypsin
(Experimental)
120 mg/kg body weight
alpha-1 antitrypsin Humman Alpha-1 Antitrypsin
(Placebo Comparator)
Placebo
placebo
Placebo

Primary Outcomes

Measure
Beta cell function
time frame: 12 months from baseline

Secondary Outcomes

Measure
Glycemic control
time frame: 12 months from baseline
Beta cell function
time frame: 12 months from baseline
Insulin dose
time frame: 12 months from baseline
Hypoglycemic episodes
time frame: 12 months from baseline
Safety parameters
time frame: 12 months from baseline

Eligibility Criteria

Male or female participants from 8 years up to 25 years old.

Main Inclusion Criteria: - Subject (or parent/guardian) willing and able to sign an informed consent - Age 8-25 (inclusive) years - Recently diagnosed with T1DM - Basal C-peptide ≥ 0.2 pmol/mL - Positive for at least one diabetes-related autoantibody - Ability and consent to comply with completion of patient diary - No significant abnormalities in serum hematology, serum chemistry - No significant abnormalities in urinalysis - No significant abnormalities in ECG - For women of child bearing potential, non-pregnant, non-lactating female patients Main Exclusion Criteria: - IgA deficient subjects - Subjects who have received an active/ live virus vaccine within 4 weeks of the screening date - Subjects who have received treatment with corticosteroid medication within 2 months prior to screening or any immunosuppressant or cytostatic agent within 6 months prior to screening - Individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis, to plasma products - Clinically significant intercurrent illnesses - Pregnant or lactating women - Current use of any medication known to influence glucose tolerance - Current or prior (within the last 60 days prior to screening visit) use of metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, DPP-IV inhibitors or amylin.

Additional Information

Official title Phase II Study to Evaluate the Efficacy and Safety of Human, Alpha-1 Antitrypsin (AAT) [Glassia®] in the Treatment of New Onset Type-1 Diabetes
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Kamada, Ltd..