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Trial record 2 of 84 for:    new onset type 1 diabetes

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

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ClinicalTrials.gov Identifier: NCT02005848
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Kamada, Ltd.

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : April 2014
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arm Intervention/treatment
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
Placebo
Other: Placebo
Placebo



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


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

  2. Beta cell function [ Time Frame: 12 months from baseline ]
  3. Insulin dose [ Time Frame: 12 months from baseline ]
  4. Hypoglycemic episodes [ Time Frame: 12 months from baseline ]
  5. Safety parameters [ Time Frame: 12 months from baseline ]
    Adverse events, vital signs, physical examination



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005848


Locations
Israel
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.

Responsible Party: Kamada, Ltd.
ClinicalTrials.gov Identifier: NCT02005848     History of Changes
Other Study ID Numbers: Kamada-AAT(IV)-011
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

Keywords provided by Kamada, Ltd.:
Type-1 Diabetes
T1D
Diabetes Mellitus

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