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Safety and immunogenicity of Insugen R and Insugen N vs Actrapid and Insulatard in type 1 diabetes mellitus
2010-018354-12Phase 3Completed
- Sponsor
- Biocon
- Start
- May 2010
- Modality
- Recombinant Proteins and Enzymes
- Countries
- 1
01
Overview
Phase 3, randomised, open-label trial in diabetes mellitus type 1 (T1D) comparing Insugen R + Insugen N with Actrapid + Insulatard (2 arms). Primary endpoints: Safety (Phase 1) and Immunogenicity (Phase 1). Started May 2010; status: completed.
02
Drugs
human insulininsulin isophane
03
Conditions
diabetes mellitus type 1 (T1D)
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