NCT02005848CompletedPhase 2
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
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Kamada, Ltd.
- Enrollment
- 70
- Locations
- 4
- Primary Endpoint
- Beta cell function
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 8 Years to 25 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
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.
Arms & Interventions
Placebo
Placebo Comparator
Placebo
Intervention: Placebo (Other)
Alpha-1 Antitrypsin (Glassia)
Experimental
120 mg/kg body weight
Intervention: Alpha-1 Antitrypsin (Biological)
Alpha1 Antitrypsin (Glassia)
Experimental
60 mg/kg body weight
Intervention: Alpha-1 Antitrypsin (Biological)
Outcomes
Primary Outcomes
Beta cell function
Time Frame: 12 months from baseline
Beta cell function (measured by C peptide)
Secondary Outcomes
- Insulin dose(12 months from baseline)
- Hypoglycemic episodes(12 months from baseline)
- Beta cell function(12 months from baseline)
- Safety parameters(12 months from baseline)
- Glycemic control(12 months from baseline)
Investigators
Study Sites (4)
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