Status:
COMPLETED
Insulin Glargine "All to Target" Trial
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-80 years
Phase:
PHASE4
Brief 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 pat...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
588 Patients enrolled
Trial Details
Trial ID
NCT00384085
Start Date
May 1 2006
End Date
March 1 2010
Last Update
May 6 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States