drugset / Trial / NCT01304537
Study of the Safety and Efficacy of Intravenous Alpha-1 Antitrypsin in Type 1 Diabetes Mellitus
RandomizedParallel-groupOpen-labelTreatment
Summary
Alpha-1 Antitrypsin (AAT), trade name (Glassia ®), is being explored in this phase I/II trial as a potential disease modifying agent in Type 1 Diabetes Mellitus (T1DM) based on its anti-inflammatory properties. AAT is an acute stress reactant protein that increases during inflammation. In T1DM inflammation serves a major role in disease progression.
Timeline
- Start
- 2011-06
- Primary completion
- 2012-11
- Completion
- 2012-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpha 1-Antitrypsin | Protein / enzyme biologic | 40 mg/kg | Intravenous |
| Subject | Alpha 1-Antitrypsin | Protein / enzyme biologic | 60 mg/kg | Intravenous |
| Subject | Alpha 1-Antitrypsin | Protein / enzyme biologic | 80 mg/kg | Intravenous |