6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both in Combination With Oral Antihyperglycemic Drug(s) 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 in Combination With Oral Antihyperglycemic Drug(s) in Patients With Type 2 Diabetes Mellitus With a 6-month Safety Extension Period
Primary Objective:
Secondary Objective:
The maximum study duration was up to approximately 58 weeks per participants, 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 6 months on basal insulin treatment together with oral antihyperglycemic drug(s) and self-monitoring of blood glucose
Participants using sulfonylurea in the last 2 months before screening visit
Any contraindication to use of insulin glargine as defined in the national product label
Use of insulin pump in the last 6 months before screening
Initiation of new glucose-lowering medications 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.
Sátorlaljaújhely, 3980, Hungary
Valancia, 46014, Spain