Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 878
Healthy volunteers: no

Brief summary:
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

Detailed description:
The maximum study duration was up to approximately 54 weeks per participant, consisting of:

* Up to 2 week screening period; it can be exceptionally extended of up to one additional week
* 6-month comparative efficacy and safety treatment period
* 6-month comparative safety extension period
* 2-day post-treatment safety follow-up period

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: HOE901-U300 (new formulation of insulin glargine) intervention 2: Lantus (insulin glargine)
Intervention descriptions: intervention 1: HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter \[mg/dL\]). intervention 2: Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).

Protocol document: