Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy (EDITION III)

• Hypoglycemia [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
• Fasting plasma glucose [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
• 8-point self-monitored plasma glucose profile [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]

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 patients with type 2 diabetes mellitus.

Secondary Objective:

To compare a new formulation of insulin glargine and Lantus in terms of occurrence of nocturnal hypoglycemia

The maximum study duration will be 54 weeks per patient, 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.

• Drug: Insulin glargine new formulation (HOE901)
  Pharmaceutical form: solution Route of administration: subcutaneous
• Drug: Insulin glargine (HOE901)
  Pharmaceutical form: solution Route of administration: subcutaneous
  Other Name: Lantus

• Experimental: Insulin glargine - new formulation
  once daily on top of non-insulin antihyperglycemic drugs
  Intervention: Drug: Insulin glargine new formulation (HOE901)
• Active Comparator: Lantus (Insulin glargine)
  once daily on top of non-insulin antihyperglycemic drugs
  Intervention: Drug: Insulin glargine (HOE901)

Inclusion criteria :

• Adult patients with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s);
• Signed written informed consent.

Exclusion criteria:

• HbA1c < 7.0% (< 53 mmol/mol) or > 11% (> 97 mmol/mol) [at screening];
• History of type 2 diabetes mellitus for less than 1 year before screening;
• Less than 6 months before screening with non-insulin antihyperglycemic treatment;
• Change in dose of non-insulin antihyperglycemic treatment in the last 3 month before screening;
• Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit and/or initiation of GLP-1 receptor agonist in the last 6 months before screening visit;
• Patients receiving only non-insulin antihyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinide (Note: non-insulin antihyperglycemic drugs not approved for combination with insulin, sulfonylurea and glinide are to be discontinued at baseline);
• Current or previous insulin use except for a maximum of 8 consecutive days (e.g. acute illness, surgery) during the last year prior to screening;
• Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (e.g. laser, surgical treatment or injectable drugs) during the study period.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.