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Sponsor: Sanofi
Conditions: Diabetes Mellitus, Type 2
Interventions: INSULIN GLARGINE
Countries: Jordan
Primary Objective: -To assess the change in glycosylated hemoglobin (HbA1c) in uncontrolled Type 2 diabetes patients on OAD agent in Jordan after 6 months of treatment with basal insulin (Insulin glargine). Secondary Objectives: * To evaluate the percentage of patients achieving target of HbA1c ˂7%. * To evaluate the change in fasting plasma glucose (FPG). * To assess the following safety criteria: hypoglycemic events, body weight changes, and overall safety. * Describe the titration process: changes in glargine insulin dose at 3 months and 6 months, changes in the titration doses used (if any), and time to reach control.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion criteria : * Patient ≥ 18 years old. * Male or Female. * Type 2 diabetes patients. * Uncontrolled with previous therapy (HbA1c \>7%), evident in HbA1c test within the last 1 month before study entry. * Insulin naïve patients: any patient uncontrolled after one or a maximum of two lines of therapy including: monotherapy (Metformin alone or any other Oral Anti-Diabetic agent (OAD) if contraindicated or intolerance) and/or dual therapy (any OAD combination), at maximum tolerated dose in the last 3 months. * Signed informed consent. * Signed informed consent. Exclusion criteria: * Patient not willing or not able to perform self-monitoring blood glucose. * Patient not willing or not able to self-titrate insulin glargine under physician's guidance. * Patient not suitable for participation according to what is specified in the approved Summary of Product's Characteristics or according to medical or clinical conditions, as judged by the Investigator. * History of impaired hepatic function defined as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than three times the upper limit of normal, evident in testing done in the last 3 months. * History of impaired renal function defined as serum creatinine \>135 μmol/L (\>1.525 mg/dL)in men and \>110 μmol/L (\>1.243 mg/dL) in women, evident in testing done in the last 3 months. * Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method at physician's discretion). * Treatment with systemic corticosteroid within 3 months prior to study entry. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
- Jordan, Jordan