Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM

Approximately 37 weeks including up to 6 weeks of screening, 30-week treatment period, and a
3 days follow-up period.

Inclusion criteria:

- Patients with type 2 diabetes mellitus diagnosed for at least 1 year before the
screening visit, treated for at least 3 months prior to visit 1 with metformin alone
or metformin and a second oral anti-diabetic treatment that can be a sulfonylurea, a
glinide, a sodium glucose co-transporter 2 inhibitor or a dipeptidyl peptidase 4
(DPP4) inhibitors, and who are not adequately controlled with this treatment.

- Signed written informed consent.

Exclusion criteria:

- HbA1c at screening visit:

- less than 7.5% or more than 10% for patients previously treated with metformin
alone,

- less than 7.0% or more than 9 % for patients previously treated with metformin
and a second oral anti-diabetic treatment.

- Pregnancy or lactation, women of childbearing potential with no effective
contraceptive method.

- Use of oral glucose-lowering agents other than those stated in the inclusion criteria
or any injectable glucose-lowering agents during the 3 months before screening.

- Previous Treatment with insulin (except for short-term treatment due to intercurrent
illness including gestational diabetes, at the discretion of the trial physician).

- History of discontinuation of a previous treatment with a GLP-1 receptor agonist
(GLP-1 RA) due to safety/tolerability issue or lack of efficacy.

- Patient who has previously participated in any clinical trial with lixisenatide or
the insulin glargine/lixisenatide fixed ratio combination or has previously received
lixisenatide.

- Any contraindication to metformin use, according to local labeling.

- Use of weight loss drugs within 3 months prior to screening visit.

- Within the last 6 months prior to screening visit: history of stroke, myocardial
infarction, unstable angina, or heart failure requiring hospitalization. Planned
coronary, carotid or peripheral artery revascularisation procedures to be performed
during the study period.

- History of pancreatitis (unless pancreatitis was related to gallstones and
cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a
previous treatment with incretin therapies, pancreatectomy, stomach/gastric surgery.

- Personal or immediate family history of medullary thyroid cancer (MTC) or genetic
conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes).

- Uncontrolled or inadequately controlled hypertension (systolic blood pressure above
180 mmHg or diastolic blood pressure above 95 mmHg) at screening visit.

- At screening visit, Body Mass Index (BMI) less than or equal to 20 or above 40 kg/m².

- At screening visit amylase and/or lipase more than 3 times the upper limit of the
normal (ULN) laboratory range.

- At screening visit ALT or AST more than 3 ULN.

- At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L).

Exclusion Criteria for randomization at the end of the screening period:

- HbA1c less than 7% or above 10%

- Fasting Plasma glucose above 250mg/dL (13.9 mmol/L)

- Metformin maximal tolerated dose less than 1500 mg/day

- Amylase and/or lipase more than 3 ULN.

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