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

Phase 2

Completed

• Conditions: New Onset Type-1 Diabetes
• Interventions: Biological: Alpha-1 Antitrypsin; Other: Placebo

• Registration Number: NCT02005848
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-27
• Study First Submitted QC: 2013-12-04
• Study First Posted: 2013-12-09
• Study Start: 2014-04
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alpha1 Antitrypsin (Glassia)	Alpha-1 Antitrypsin	60 mg/kg body weight
Placebo	Placebo	Placebo
Alpha-1 Antitrypsin (Glassia)	Alpha-1 Antitrypsin	120 mg/kg body weight

Primary Outcome Measures

Name	Time	Method
Beta cell function	12 months from baseline	Beta cell function (measured by C peptide)

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Assaf Harofe Medical Center; 🇮🇱 Zerifin, Israel

Rambam Medical Center; 🇮🇱 Haifa, Israel

Schneider Children's Medical Center; 🇮🇱 Pethach Tikva, Israel

Soroka Medical Center; 🇮🇱 Beer Sheva, Israel