drugset / Trial / NCT00290979

Efficacy and Safety of Insulin Glulisine in Type 1 Diabetes Mellitus

NCT00290979 ↗

Phase 3 Completed 250 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

* To evaluate non-inferiority in the efficacy of HMR1964 as compared with Insulin lispro in terms of the change in HbA1C from baseline to endpoint. * To compare the safety of HMR1964 with insulin lispro.

Timeline

Start
2004-12
Primary completion
—
Completion
—

Outcome

Met primary endpoint

paper Non-inferiority of glulisine compared with lispro was shown. PMID 19614947 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin glulisine Protein / enzyme biologic — —