Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin

Up to 34 weeks, including a Screening Phase of up to 2 weeks, a 2 week Run-In Phase, a
26-week double-blind Treatment Period and a 4-week post-treatment Follow-up Period to collect
safety information.

Inclusion criteria :

- Patients with Type 2 Diabetes on Dipeptidyl peptidase-4 inhibitors(DPP4(i)) with or
without metformin at a stable dose for at least 12 weeks prior to Screening Visit.
Metformin dose will be ≥1500 mg per day (or maximum tolerated dose [documented]).
DPP4(i) dose must be the appropriate dose as per local label.

- Signed written informed consent.

Exclusion criteria:

- Body mass index (BMI) ≤20 kg/m² or >45 kg/m² at Screening.

- Use of any antidiabetic drug other than DPP4 inhibitors and metformin within 12 weeks
preceding the Screening Visit.

- Patients who have previously participated in any clinical trial of
sotagliflozin/LX4211.

- Use of a selective sodium-glucose co-transporter type 2 (SGLT2) inhibitor (e.g.,
canagliflozin, dapagliflozin, or empagliflozin) within 3 months prior to screening
visit.

- Patients with severe anemia, severe cardiovascular disease (including congestive heart
failure New York Heart Association IV), respiratory, hepatic, neurological,
psychiatric, or active malignant tumor or other major systemic disease or patients
with short life expectancy that, according to Investigator, will preclude their safe
participation in this study, or will make implementation of the protocol or
interpretation of the study results difficult.

- Current diagnosis of chronic hepatitis and/or other clinically active liver disease
requiring treatment.

- Patients with contraindication to empagliflozin as per local labeling.

- Patients with contraindication to metformin as per local labeling.

- Hemoglobin A1c <7.0% or >11.0% at Screening (central laboratory).

- Fasting plasma glucose >270 mg/dL (>15.0 mmol/L) measured by the central laboratory at
Screening (Visit 1), and confirmed by a repeat test (>270 mg/dL [>15.0 mmol/L]) before
Randomization.

- Previous use of any types of insulin for >1 month (except for treatment of gestational
diabetes).

- Pregnant (confirmed by serum pregnancy test at Screening) or breast-feeding women.

- Women of childbearing potential not willing to use highly effective method(s) of birth
control during the study treatment period and follow-up period, or who are unwilling
or unable to be tested for pregnancy during the study.

- Mean of 3 separate blood pressure (BP) measurements >180 mmHg (systolic blood pressure
[SBP]) or >100 mmHg (diastolic blood pressure [DBP]).

- History of hypertensive crisis resulting in emergency medical care within 12 weeks
prior to Screening Visit.

- Lower extremity complications (such as skin ulcers, infection, osteomyelitis and
gangrene) identified during the Screening period, and still requiring treatment at
Randomization.

- Laboratory findings with the central laboratory tests at Visit 1:

- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper
limit of the normal laboratory range (ULN);

- Total bilirubin >1.5 times the ULN (except in case of Gilbert's syndrome);

- Neutrophils <1 500/mm3 (or according to ethnic group) and/or platelets <100 000/mm3;

- Amylase and/or lipase >3 times the ULN;

- Patients with renal impairment as defined by the estimated glomerular filtration rate
(eGFR) criterion that precludes initiation of empagliflozin as per the approved local
label (eg, <45 mL/min/1.73 m2 in US; <60 mL/min/1.73 m2 in EU).

- Secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma,
Cushing's syndrome).

- If the patient is on hypertensive medications, the antihypertensive has been changed
in the 8 weeks prior to Screening (new drug or new dose).

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