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

Primary Purpose

New Onset Type-1 Diabetes

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Alpha-1 Antitrypsin

Placebo

About this trial

This is an interventional treatment trial for New Onset Type-1 Diabetes focused on measuring Type-1 Diabetes, T1D, Diabetes Mellitus

Eligibility Criteria

8 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Soroka Medical Center
Rambam Medical Center
Schneider Children's Medical Center
Assaf Harofe Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Alpha1 Antitrypsin (Glassia)

Alpha-1 Antitrypsin (Glassia)

Placebo

Arm Description

60 mg/kg body weight

120 mg/kg body weight

Placebo

Outcomes

Primary Outcome Measures

Beta cell function

Beta cell function (measured by C peptide)

Secondary Outcome Measures

Glycemic control

Glycemic control expressed in HbA1c level

Beta cell function

Insulin dose

Hypoglycemic episodes

Safety parameters

Adverse events, vital signs, physical examination

Full Information

NCT ID

NCT02005848

First Posted

November 27, 2013

Last Updated

October 10, 2018

Sponsor

Kamada, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02005848

Brief Title

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

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

April 2014 (undefined)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kamada, Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

New Onset Type-1 Diabetes

Keywords

Type-1 Diabetes, T1D, Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Alpha1 Antitrypsin (Glassia)

Arm Type

Experimental

Arm Description

60 mg/kg body weight

Arm Title

Alpha-1 Antitrypsin (Glassia)

Arm Type

Experimental

Arm Description

120 mg/kg body weight

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Biological

Intervention Name(s)

Alpha-1 Antitrypsin

Other Intervention Name(s)

Humman Alpha-1 Antitrypsin, Alpha-1 Proteinase Inhibitor, API, AAT

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Beta cell function

Description

Beta cell function (measured by C peptide)

Time Frame

12 months from baseline

Secondary Outcome Measure Information:

Title

Glycemic control

Description

Glycemic control expressed in HbA1c level

Time Frame

12 months from baseline

Title

Beta cell function

Time Frame

12 months from baseline

Title

Insulin dose

Time Frame

12 months from baseline

Title

Hypoglycemic episodes

Time Frame

12 months from baseline

Title

Safety parameters

Description

Adverse events, vital signs, physical examination

Time Frame

12 months from baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Soroka Medical Center

City

Beer Sheva

Country

Israel

Facility Name

Rambam Medical Center

City

Haifa

Country

Israel

Facility Name

Schneider Children's Medical Center

City

Pethach Tikva

Country

Israel

Facility Name

Assaf Harofe Medical Center

City

Zerifin

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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