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

New Onset Type-1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02005848
• Other study ID #: Kamada-AAT(IV)-011
• Status: Completed
• Phase: Phase 2
• Start date: April 2014
• Est. completion date: February 2017

Study information

• Verified date: October 2018
• Source: Kamada, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• New Onset Type-1 Diabetes

Intervention

Biological:
• Alpha-1 Antitrypsin

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Kamada, Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beta cell function	Beta cell function (measured by C peptide)	12 months from baseline
Secondary	Glycemic control	Glycemic control expressed in HbA1c level	12 months from baseline
Secondary	Beta cell function		12 months from baseline
Secondary	Insulin dose		12 months from baseline
Secondary	Hypoglycemic episodes		12 months from baseline
Secondary	Safety parameters	Adverse events, vital signs, physical examination	12 months from baseline