Phase II Study to Evaluate the Efficacy and Safety of Glassia® in Type-1 Diabetes

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02005848

Enrollment

Registered

2013-12-09

Start date

2014-04-30

Completion date

2017-02-28

Last updated

2018-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

New Onset Type-1 Diabetes

Keywords

Type-1 Diabetes, T1D, Diabetes Mellitus

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.

Interventions

BIOLOGICALAlpha-1 Antitrypsin

OTHERPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

8 Years to 25 Years

Healthy volunteers

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 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.

Design outcomes

Primary

Measure	Time frame	Description
Beta cell function	12 months from baseline	Beta cell function (measured by C peptide)

Secondary

Measure	Time frame	Description
Glycemic control	12 months from baseline	Glycemic control expressed in HbA1c level
Beta cell function	12 months from baseline	—
Insulin dose	12 months from baseline	—
Hypoglycemic episodes	12 months from baseline	—
Safety parameters	12 months from baseline	Adverse events, vital signs, physical examination

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026