An Open Label Randomized Multicenter Study to Assess Patient Preference for and Evaluate Clinical Benefit of Insulin Glargine (Lantus®) SoloSTAR® Pen Versus Conventional Vial/Syringe Method of Insulin Glargine (Lantus®) Injection Therapy in Patients With Type 2 Diabetes Mellitus

Detailed Summary

Primary Objective: To assess patient preference for Lantus SoloSTAR pen versus Lantus vial and syringe at the end of Crossover Phase (Week 4) in patients with type 2 diabetes mellitus (T2DM) Secondary Objectives: To compare Lantus SoloSTAR pen versus Lantus vial and syringe with regard to the following parameters: Randomization/Crossover phase: * Healthcare professional's (HCP) recommendation for Lantus SoloSTAR pen versus Lantus vial and syringe Re-randomization phase: * Change in Fasting Plasma Glucose (FPG) from week 4 to week 10 * Percentage of patients achieving FPG\<110 mg/dL at week 10 * Change in Lantus dose injected per day (U) from week 4 to week 10 Observational phase: * Percentage of patients achieving glycosylated hemoglobin (HbA1c) goal (\<7%) at week 40 * Time to first observation of HbA1c\<7% during the observational phase * Percentage of patients who discontinue Investigational Product (IP) during the observational phase due to dissatisfaction with their current device All phases: * Percentage of patients who discontinue IP during each phase of the study * Safety assessment such as occurrence of hypoglycemic events (HE) and adverse events (AE)

Study Details

Timeline

Interventions