drugset / Trial / NCT00546702

Glulisine + Lantus in Type I Patients

NCT00546702

Phase 3 Completed 142 enrolled Sanofi
Non-randomizedSingle-groupOpen-labelTreatment

Summary

To evaluate the efficacy (in terms of change HbA1c from baseline to endpoint) and safety (in terms of adverse events, clinical chemistry, lipids, hematology) of insulin glulisine (HMR 1964) in subjects with type I diabetes mellitus To evaluate the change in HbA1c at week 26, blood/glucose parameters, hypoglycemia, insulin dose in subjects with type I diabetes mellitus receiving HMR 1964 and insulin glargine.

Timeline

Start
2004-09
Primary completion
2005-02
Completion
2005-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin glulisine Protein / enzyme biologic Subcutaneous