Insulin Glargine "All to Target" Trial

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Biphasic Insulins; Insulin; Insulin Aspart; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin Glargine; Insulin glulisine; Insulin, Globin Zinc; Insulin, Isophane

Criteria

• Male or female patients

• 30 to 80 years of age

• Body Mass Index <45 kg/m2

• With Type 2 diabetes mellitus for at least 2 years

• With an HbA1c level at screening of >7.5% and >7.0% at randomization

• On stable dual or triple oral therapy for at least 3 months

• Oral agents in 2 or 3 of the following classes: SU or repaglinide, biguanide, or TZD, willing and able to perform self-monitoring of BG

• Females of child-bearing potentially were required to be willing and able to use adequate contraception