6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both Plus Mealtime Insulin in Patients With Type 2 Diabetes Mellitus With a 6-month Safety Extension Period
6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both Plus Mealtime Insulin in Patients With Type 2 Diabetes Mellitus With a 6-month Safety Extension Period
Primary Objective:
Secondary Objectives:
The maximum study duration was up to approximately 58 weeks per participant, consisting of:
Inclusion criteria :
Participants with type 2 diabetes mellitus
Substudy inclusion criteria:
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 product label
Participants using human regular insulin as mealtime insulin in the last 3 months before 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 3 months before screening visit
History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period
Pregnant or breast-feeding women or women who intend to become pregnant during the study period
Substudy exclusion criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Nyiregyháza, 4400, Hungary
Sátorlaljaújhely, 3980, Hungary