Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin

Inclusion criteria :

• Participants with type 2 diabetes mellitus
• Substudy inclusion criteria:
• Completion of the 6-month study period in main study (Visit 10)
• Randomized and treated with insulin glargine new formulation during the 6-monthtreatment period (Baseline - month 6)

Exclusion criteria:

• Age less than (<) 18 years
• HbA1c <7.0% or greater than (>) 10% at screening
• Diabetes other than type 2 diabetes mellitus
• Less than 1 year on basal plus mealtime insulin and self-monitoring of blood glucose
• Any contraindication to use of insulin glargine as defined in the national productlabel
• Participants using human regular insulin as mealtime insulin in the last 3 monthsbefore screening visit
• Use of an insulin pump in the last 6 months before screening visit
• Initiation of new glucose-lowering agents and/or weight loss drugs in the last 3months before screening visit
• History or presence of significant diabetic retinopathy or macular edema likely torequire laser or injectable drugs or surgical treatment during the study period
• Pregnant or breast-feeding women or women who intend to become pregnant during thestudy period
• Substudy exclusion criteria:
• Participant not willing to use the adaptable injection intervals on at least twodays per week The above information is not intended to contain all considerations relevant to aparticipant's potential participation in a clinical trial.