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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Kamada, Ltd. Identifier:
First received: November 27, 2013
Last updated: June 8, 2016
Last verified: April 2016

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.

Condition Intervention Phase
New Onset Type-1 Diabetes
Biological: Alpha-1 Antitrypsin
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Kamada, Ltd.:

Primary Outcome Measures:
  • Beta cell function [ Time Frame: 12 months from baseline ]
    Beta cell function (measured by C peptide)

Secondary Outcome Measures:
  • Glycemic control [ Time Frame: 12 months from baseline ]
    Glycemic control expressed in HbA1c level

  • 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 ]
    Adverse events, vital signs, physical examination

Enrollment: 71
Study Start Date: April 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alpha1 Antitrypsin (Glassia)
60 mg/kg body weight
Biological: Alpha-1 Antitrypsin
Other Names:
  • Humman Alpha-1 Antitrypsin
  • Alpha-1 Proteinase Inhibitor
  • API
  • AAT
Experimental: Alpha-1 Antitrypsin (Glassia)
120 mg/kg body weight
Biological: Alpha-1 Antitrypsin
Other Names:
  • Humman Alpha-1 Antitrypsin
  • Alpha-1 Proteinase Inhibitor
  • API
  • AAT
Placebo Comparator: Placebo
Other: Placebo


Ages Eligible for Study:   8 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT02005848

Soroka Medical Center
Beer Sheva, Israel
Rambam Medical Center
Haifa, Israel
Schneider Children's Medical Center
Pethach Tikva, Israel
Assaf Harofe Medical Center
Zerifin, Israel
Sponsors and Collaborators
Kamada, Ltd.
  More Information

Responsible Party: Kamada, Ltd. Identifier: NCT02005848     History of Changes
Other Study ID Numbers: Kamada-AAT(IV)-011
Study First Received: November 27, 2013
Last Updated: June 8, 2016

Keywords provided by Kamada, Ltd.:
Type-1 Diabetes
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Alpha 1-Antitrypsin
Protein C Inhibitor
Protease Inhibitors
Trypsin Inhibitors
Serine Proteinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017