drugset / Trial / NCT00467376

Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes Mellitus

NCT00467376

Phase 3 Completed 485 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

Primary: * To compare the efficacy and safety of Insulin Glulisine to Insulin Lispro in subjects with type 1 or type 2 diabetes mellitus. * To compare the frequency of hypoglycemia of Insulin Glulisine to Insulin Lispro. Secondary: * To compare Insulin Glulisine to Insulin Lispro in terms of the change in HbA1c at weeks 12, blood glucose parameters, insulin doses and treatment satisfaction in subjects with type 1 or type 2 diabetes mellitus

Timeline

Start
2007-01
Primary completion
2008-06
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Insulin Lispro Protein / enzyme biologic Subcutaneous
Subject Insulin glulisine Protein / enzyme biologic Subcutaneous
Background insulin glargine Protein / enzyme biologic

Indications