Clinical trial NCT02005848: Phase II Study to Evaluate the Efficacy and Safety of Glassia® in Type-1 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: New Onset Type-1 Diabetes
Keywords: Type-1 Diabetes
T1D
Diabetes Mellitus
Lead sponsor: Kamada, Ltd.
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 70
Sex: ALL
Minimum age (years): 8
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

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.

Primary outcomes:
measure: Beta cell function
timeFrame: 12 months from baseline
Secondary outcomes:
measure: Glycemic control
timeFrame: 12 months from baseline
measure: Beta cell function
timeFrame: 12 months from baseline
measure: Insulin dose
timeFrame: 12 months from baseline
measure: Hypoglycemic episodes
timeFrame: 12 months from baseline
measure: Safety parameters
timeFrame: 12 months from baseline
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Pethach Tikva
country: Israel
facility: Schneider Children's Medical Center
city: Zerifin
country: Israel
facility: Assaf Harofe Medical Center
Study officials:
References: