Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 405
Healthy volunteers: no

Brief 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)

Detailed description:
This study consisted of a 1 week Screening Phase, a 4-week Randomization/Crossover Phase, a 6-week Re-randomization Phase, followed by a 30 week Observational Phase.

The total duration of study participation was up to 41 weeks with a total treatment duration of up to 40 weeks of Lantus exposure.

Arms:
arm 1: 10 mL vial, 1000 U per vial for subcutaneous administration once a day. Starting dose will be 0.2 Unit per kilogram of body weight. arm 2: 3 mL SoloSTAR pre-filled disposable insulin delivery device (pen), 300 U per device for subcutaneous administration once a day. Starting dose will be 0.2 Unit per kilogram of body weight.

Interventions: intervention 1: Insulin Glargine
Intervention descriptions: intervention 1: * Pharmaceutical form: solution for injection
* Route of administration: subcutaneous

Protocol document: