Study Comparing the Efficacy and Safety of Insulin Glargine (Basal Insulin)/Lixisenatide (GLP-1 Receptor Agonist) Combination (Soliqua™) in Patients With Type 2 Diabetes Mellitus (T2DM)

Inclusion criteria:

• Adult subject ≥ 18 years
• Patients with type 2 diabetes mellitus (T2DM) based on Diabetes Canada 2018 ClinicalPractice Guidelines criteria and diagnosed at least 6 months prior to the screeningvisit
• Uncontrolled glycemia with an A1c ≥7.5% and ≤10.5%
• Patients treated for at least 6 months on any basal insulin (including but not limitedto insulin glargine, Toujeo®, Degludec®, etc.) ± oral anti-diabetic drug (OADs)
• The total basal insulin dose must be ≤ 40 units/day
• The OADs allowed at inclusion are metformin, insulin secretagogues,dipeptidyl-peptidase-4 inhibitors (DPP4) inhibitors and SGLT2 inhibitors; with nochange in OAD dose for at least 2 months prior to randomization
• Body mass index (BMI) between 20 kg/m2 and 40 kg/m2 inclusively

Exclusion criteria:

• History of severe hypoglycemia or hypoglycemia unawareness
• History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior toscreening visit
• Current or previous (known intolerance to GLP-1s) treatment with glucagon likepeptide-1 (GLP-1) receptor agonist
• Current use of rapid-acting insulin or premix insulins or use of these insulins within 3 months prior to the screening visit
• Use of systemic glucocorticoids (excluding topical and inhaled forms) for a totalduration of 1 week or more within 3 months prior to the screening visit
• Use of weight loss drugs within 3 months prior to the screening visit
• Patients with conditions/concomitant diseases that will affect safe participation inthis study (e.g. active malignant tumor, major systemic diseases, presence ofclinically significant diabetic retinopathy or presence of macular edema likely torequire treatment within the study period, etc.)
• Women of childbearing potential (WOCBP) not protected by an effective contraceptivemethod of birth control and/or who are unwilling or unable to be tested for pregnancy
• Positive serum pregnancy test in WOCBP, pregnancy or lactation
• Clinically relevant history of gastrointestinal disease associated with prolongednausea and vomiting, including (but not limited to): gastroparesis, unstable (i.e.worsening) or uncontrolled (i.e. prolonged nausea and vomiting) gastroesophagealreflux disease requiring medical treatment within 6 months prior to the time ofscreening visit
• History of pancreatitis (unless pancreatitis was related to gallstones and treatedwith cholecystectomy), pancreatitis during previous treatment with incretin therapies,chronic pancreatitis, pancreatectomy, or stomach/gastric surgery
• Personal or immediate family history of medullary thyroid cancer or genetic conditionsthat predispose the patient to medullary thyroid cancer (e.g. multiple endocrineneoplasia syndromes) The above information is not intended to contain all considerations relevant to a patient'spotential participation in a clinical trial.