6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Non-Insulin Antihyperglycemic Drugs 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® in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Non-Insulin Antihyperglycemic Drugs With a 6-month Safety Extension Period
Primary Objective:
To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in participants with type 2 diabetes mellitus
Secondary Objectives:
To compare a new formulation of insulin glargine and Lantus in terms of:
- occurrence of nocturnal hypoglycemia
The maximum study duration was up to approximately 54 weeks per participant, consisting of:
Inclusion criteria :
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Ise-Shi, Japan
Kitaazumi-Gun, Japan
Matsumoto-Shi, Japan
Shunan-Shi, Japan
Cagua, 725, Puerto Rico