drugset / Trial / NCT01357603

Comparative Glucose Clamp Study of Wockhardt's Recombinant Insulin Analog Glargine(Glaritus) With Lantus in T1DM

NCT01357603

Phase 1 Completed 111 enrolled Wockhardt
RandomizedCrossoverQuadruple-blindHealth-services research

Summary

The aim of this trial is to demonstrate bioequivalence of Glaritus® to Lantus® with regard to its total and to its maximum serum insulin concentrations.

Timeline

Start
2011-06
Primary completion
2012-05
Completion
2012-08

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin glargine Protein / enzyme biologic Subcutaneous