Effectiveness and Safety of Treatment of Insulin Glargine in Type 2 Diabetes Mellitus Following Glucagon-like Peptide-1 (GLP-1) Failure

Primary Objective:

* To assess the efficacy of insulin glargine as measured by changes of HbA1c levels from baseline in type 2 diabetes mellitus (T2DM) patients following GLP-1 failure.

Secondary Objective:

* To determine the change in glycemic control, safety, and treatment satisfaction in insulin glargine use in patients following GLP-1 failure.

1-2 weeks screening period, 24 weeks treatment period, 1 week follow-up period

Eligibility Criteria:
Inclusion criteria:

* Patients of aged ≥30 and ≤75 years with type 2 diabetes mellitus (T2DM)
* Hemoglobin A1c (glycosylated hemoglobin; HbA1c) levels measured at screening ≥7.5%
* Continuous treatment with stable doses of GLP-1 analogue for \>3 months prior to enrollment (for patients also using oral anti-hyperglycemic drugs \[OADs\], continuous treatment with stable doses of OADs for \>3 months prior to enrollment)

Exclusion criteria:

* Inpatient with T2DM
* Diabetes other than T2DM (e.g. secondary to pancreatic disorders, drug or chemical agent intake)
* Fasting plasma glucose (FPG) levels \<130mg/dL
* Body mass index (BMI) \>28 kg/m2
* Patients using thiazolidinediones in the last 3 months prior to enrollment
* Use of any treatment for weight loss in the last 3 months prior to enrollment
* Treatment with systemic corticosteroids within the 3 months prior to enrollment
* Patients using non-selective ß-blockers
* Likelihood of requiring treatment during the study period with drugs not permitted by the clinical trial protocol
* Most recent ophthalmologic examination \>6 months prior to enrollment
* Diabetic retinopathy with surgical treatment (last photocoagulation or vitrectomy) in the 3 months before enrollment or which may require surgical treatment
* Proliferative diabetic retinopathy or any other unstable rapidly progressive retinopathy
* Impaired renal function defined as, but not limited to, serum creatinine ≥1.3 mg/dL \[males\] or ≥1.2 mg/dL \[females\] or presence of macroproteinuria (\>1 g/day)
* Active liver disease including hepatic cirrhosis, hepatic failure, and hepatitis or alanine transaminase (ALT) or aspartate aminotransferase (AST) \>2 times upper limit or total bilirubin \>1.5 times upper limit of normal (except in case of Gilbert's syndrome) at enrollment
* Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol
* Any medical condition that may have an influence on HbA1c rate
* Currently undergoing therapy for malignancy which may affect the study evaluation
* Use of any investigational product and/or device within the 2 months prior to enrollment
* History of ketoacidosis or hyperosmolar hyperglycemic state during the previous 12 months prior to enrollment
* History of stroke, myocardial infarction, angina pectoris, coronary artery bypass graft or percutaneous transluminal coronary angioplasty within the previous 12 months prior to enrollment
* History of congestive heart failure
* History of hypoglycemia unawareness or unexplained hypoglycemia during the previous 12 months prior to enrollment
* Hemoglobinopathy or hemolytic anemia, transfusion of blood or plasma products within 3 months prior to enrollment
* Known hypersensitivity / intolerance to insulin glargine or any of its excipients
* History of pancreatitis
* Pregnant or breast-feeding women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method)
* Shift workers or those who regularly work a night-time shift

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