Study of the Safety and Efficacy of Intravenous Alpha-1 Antitrypsin in Type 1 Diabetes Mellitus

This is an interventional treatment trial for Type 1 Diabetes Mellitus Read More

Inclusion Criteria:

• Subject (or parent/guardian) willing and able to sign an informed consent
• Age 10-25 (inclusive) years
• Diagnosed with T1DM within the previous 6 months
• Level of C-peptide ≥ 0.2 pmol/mL during MMTT(maximal level)
• Positive for at least one diabetes-related autoantibody(except for insulin autoantibody)
• No significant abnormalities in serum hematology,serum chemistry according to the Investigator's judgment, taking into considerations the potential effects of the diabetic illness.
• No significant abnormalities in urinalysis according to the Principal Investigator's judgment, taking into considerations the potential effects of the diabetic illness.
• No significant abnormalities in ECG per investigator judgment
• Negative for HBsAg and antibodies to HCV, HIV-1
• Non-pregnant, non-lactating female patients, whose screening pregnancy test is negative and who are using contraceptive methods deemed reliable by the investigator.

Exclusion Criteria:

• 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
• IgA deficient subjects
• Individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis, to plasma products
• Planned major surgery within the study period
• Clinically significant intercurrent illnesses, including(but not limited to): cardiac, hepatic, renal,neurological, hematological, neoplastic, immunological, skeletal or other) that in the opinion of the investigator, could interfere with the safety, compliance or other aspects of this study. Patients with well-controlled, chronic diseases could be possibly included after consultation with the treating physician and the sponsor.
• Pregnant or lactating women at entry to study and those who are unwilling to agree to continue to use acceptable methods of contraception throughout the study.
• Presence of psychiatric/ mental disorder or any other medical disorder which might impair the patient's ability to give informed consent or to comply with the requirements of the study protocol.
• Evidence of ongoing viral infection with HCV, HBV and/or HIV-1.
• Evidence of alcohol abuse or history of alcohol abuse or illegal and/or legally prescribed drugs.
• Participation in another interventional clinical trial within 30 days prior to baseline visit.
• Inability to attend scheduled clinic visits and/or comply with the study protocol.
• Any other factor that, in the opinion of the investigator, would prevent the patient form complying with the requirements of the protocol.
• Current use of any medication known to influence glucose tolerance (e.g., beta-blockers, angiotensin-converting enzyme inhibitors, interferons, quinidine anti-malarial drugs, lithium, niacin).
• Current or prior (within the last 30 days prior to screening visit) use of metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, DPP-IV inhibitors or amylin.