drugset / Trial / NCT00384085

Insulin Glargine "All to Target" Trial

NCT00384085

Phase 4 Completed 588 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objectives were: * To demonstrate the superiority of Lantus plus stepwise addition of mealtime Apidra® (Lantus/Apidra-3) versus twice-daily Premixed insulin based on the proportion of patients achieving target glycemic control (as measured by hemoglobin A1c \[HbA1c\] \<7.0%) at Week 60 * To demonstrate the noninferiority of Lantus plus addition of 1 mealtime Apidra injection (Lantus/Apidra-1) versus twice-daily Premixed insulin based on the reduction from Baseline to Week 60 in HbA1c

Timeline

Start
2006-05
Primary completion
2010-03
Completion
2010-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin glulisine Protein / enzyme biologic Subcutaneous
Subject Novolog® Mix 70/30 Unknown Subcutaneous
Subject insulin glargine Protein / enzyme biologic Subcutaneous