Safety Assessment of Lyxumia (Lixisenatide) and Sulfonylurea as Add-on Treatment to Basal Insulin in Uncontrolled Patients With Type 2 Diabetes Mellitus Who Elect to Fast During Ramadan

Exclusion Criteria

• •At the time of screening age \< legal age of majority.
• •Glycated hemoglobin (HbA1c) at screening visit: \<7.5% or \>10%.
• •Body mass index (BMI) \<20kg/m\^2.
• •Treatment with basal insulin for less than 6 months prior to screening.
• •Prior antidiabetic medication (basal insulin and OADs) not at stable dose (eg, same medication, frequency and \<20% dose change) in the last 8 weeks prior to screening.
• •Previous treatment with short or rapid acting insulin other than for short term use (≤10 days) in relation to hospitalization or an acute illness in the last 6 months prior to screening.
• •Any discontinuation from a glucagon like peptide-1 receptor agonist (GLP-1 RA) due to safety/tolerability issue or lack of efficacy.
• •Patient not willing to perform self-monitored plasma glucose (SMPG) as required by protocol and to follow the instructions provided.
• •Type 1, gestational or secondary diabetes.
• •History of diabetic ketoacidosis.
• •History of hypoglycemia unawareness.
• •Any medical contraindication for sustained and safe fasting.
• •Pregnant or breast-feeding women.
• •Women of childbearing potential (WOCB) not protected by highly effective contraceptive method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy.
• •Known hypersensitivity/intolerance to lixisenatide (Lyxumia) or any of its excipients.
• •All contraindications of the comparator and protocol mandated background therapies or warning/precaution of use (when appropriate) as displayed in the respective National Product Labeling.
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.