drugset / Trial / NCT01352663
Immunogenicity Safety Study of Wockhardt's Recombinant Insulin Analogue in Type 1 Diabetic Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open label, randomized, parallel group comparison of the immunogenicity safety of Wockhardt's Recombinant Insulin Analogue with the innovator's Glargine in Type 1 diabetics patients.
Timeline
- Start
- —
- Primary completion
- —
- Completion
- —
Outcome
Outcome not reported
Stopped (Business): “Business strategy decision”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Wockhardt's Insulin Analogue (Recomb) | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | insulin glargine | Protein / enzyme biologic | — | Subcutaneous |