Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes

Maximum duration of approximately 39 weeks: an up to 8-week screening period, a 30-week
randomized treatment period and 3 days post-treatment safety follow up period.

Inclusion criteria :

- Type 2 diabetes mellitus diagnosed at least 1 year before the screening visit.

- Treatment with basal insulin for at least 6 months before the screening visit.

- Stable basal insulin regimen (i.e. type of insulin and time/frequency of the
injection) for at least 3 months before the screening visit.

- Stable (plus/minus 20 percent) total daily basal insulin dose between 15 and 40U/day
for at least 2 months prior to the screening visit.

- For patients receiving basal insulin AND 1 or 2 oral anti-diabetic drugs (OADs): the
OAD dose(s) must be stable during the 3 months before the screening visit. The OADs
can be 1 to 2 out of:

- metformin (more than or equal to1500mg/day or maximal tolerated dose),

- a sulfonylurea

- a glinide,

- a dipeptidyl-peptidase-4 inhibitor

- a sodium glucose co-transporter 2 inhibitor

- Fasting plasma glucose (FPG) less than or equal to 180 mg/dL(10.0 mmol/L) at
screening visit for patients receiving basal insulin in combination with 2 OADs or
with 1 OAD other than metformin; FPG less than or equal to 200 mg/dL (11.1 mmol/L) at
screening visit for patients on basal insulin only or basal insulin plus metformin at
screening visit,

- Signed written informed consent.

Exclusion criteria:

- Age under legal age of adulthood at screening visit

- HbA1c at screening visit less than 7.5% or above 10%.

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

- Use of other oral or injectable glucose-lowering agents than stated in the inclusion
criteria in a period of 3 months prior to screening.

- Previous use of insulin other than basal insulin eg, prandial or pre-mixed insulin,
in the year prior to screening. Note: Short term treatment (≤10 days) due to
intercurrent illness is allowed.

- History discontinuation of a previous treatment with Glucagon Like Peptide -1
Receptor Agonists for safety/tolerability 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.

- 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)

- Any contraindication to metformin use, according to local labeling, if the patient is
taking metformin.

- Patient who has a renal function impairment with creatinine clearance less than 30
mL/min (using the Cockroft and Gault formula) or end-stage renal disease for
patients, not treated with metformin.

Exclusion criteria for randomization:

- HbA1c less than 7% or above 10% .

- Mean fasting Self Measured Plasma Glucose (SMPG) calculated from the
self-measurements for 7 days the week before randomization visit is above 140 mg/dL
(7.8 mmol/L).

- Average insulin glargine daily dose less than 20U or above 50U ( in the week before
randomization visit).

- 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.