Evaluation of the Effectiveness and Safety of Physician Versus Patient-led of Insulin Glargine Initiation and Titration in Type 2 Diabetes Mellitus

Inclusion criteria

• Diagnosed with T2DM duration of T2DM > 2 years
• Insulin naïve
• Continuous treatment with stable doses of 2 OADs (sulphonylureas, biguanides, alpha-glucosidase inhibitors, DPP-IV inhibitors, and glinides) for > three months prior to randomization
• HbA1c levels 7% and 11 %
• Body mass index (BMI) 20 and 40 kg/m2
• Willing and able to perform blood glucose monitoring using a blood glucose meter

Exclusion criteria

• Diabetes other than type 2 diabetes (e.g. secondary to pancreatic disorders, drug or chemical agent intake),
• Current or previous use of insulin (except for previous treatment of gestational diabetes or brief treatment with insulin for < 1 week),
• Current treatment with thiazolidinediones,
• Current or previous use (within the last 3 months) of GLP-1 receptor agonists or GLP-1 analogues,
• Current or previous (within the last 3 months) use of any treatment for weight lost,
• Active proliferative diabetic retinopathy,
• Patient without any history of eye examination in the past 6 months,
• Treatment with systemic corticosteroids in the 3 months prior to study entry,
• Currently receiving treatment with monoamine oxidase inhibitors,
• Currently receiving treatment with non-selective -blockers,
• Treatment with any investigational product and/or device in the 2 months prior to study entry,
• Likelihood of requiring treatment during the study period with drugs not permitted by the clinical trial protocol,
• History of ketoacidosis or hyperosmolar hyperglycemic state,
• History of stroke, myocardial infarction, angina pectoris, coronary artery bypass graft or percutaneous transluminal coronary angioplasty within the previous 12 months,
• History of congestive heart failure,
• History of hypoglycemia unawareness,
• Unexplained hypoglycemia in the past 6 months,
• Impaired renal function defined as, but not limited to, serum creatinine 1.5 mg/dL (133 mol/L) males or 1.4 mg/dL (124 mol/L) females or presence of macroproteinuria (>2gr/day),
• Active liver disease (alanine transaminase ALAT greater than two times the upper limit of the reference range, as defined by the local laboratory),
• Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol,
• Had a blood transfusion or severe blood loss within the 3 months before screening, or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia,
• Known hypersensitivity / intolerance to insulin glargine or any of its excipients,
• History of pancreatitis,
• Currently undergoing therapy or planned radiological examinations requiring the administration of contrasting agents for malignancy (other than non-metastatic / early stage basal cell or squamous cell carcinoma),
• Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method),
• Any medical condition that may have an influence on HbA1c rate.

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