effectiveness and safety of treatment of insulin glargine in type 2 diabetes mellitus following glucagon-like peptide-1 (glp-1) failure

Conditions: Type 2 Diabetes Mellitus

Summary: 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.