Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents

The study duration as approximately 29 weeks including 2 weeks screening period, 26 weeks
open label treatment period, and a 3 days follow-up period.

Inclusion criteria :

- Patients with type 2 diabetes mellitus (T2DM) diagnosed at least 1 year prior to the
screening visit (signing of informed consent).

- Uncontrolled diabetes as demonstrated by a screening centrally measured hemoglobin A1c
(HbA1c) between 7.5% and 10% (inclusive).

- Patients who are Hispanics of any race, non-Hispanic black/African Americans or
non-Hispanic Asians. Note: Decision for ethnic/racial inclusion will be made based on
the patient's self-identification. Mixed-race patients must select 1 of the
above-mentioned categories. If such selection cannot be made, the candidate will be
ineligible to participate in the study.

- Patients who have been treated with any basal insulin (ie, glargine - U100 or U300,
detemir, degludec, intermediate-acting [human Neutral Protamine Hagedorn (NPH)) for at
least 6 months prior to Visit 1.

- The basal insulin regimen (ie, type of insulin and time/frequency of the injection)
has been stable for at least 3 months prior to Visit 1.

- The basal insulin dose has been stable (defined as up to ±20% [1/5 of the dose]
variability) for at least 2 months prior to Visit 1 within the following dose ranges:

- 15 to 50 units/day if HbA1c at Visit 1 is ≤8.5%, and

- 15 to 40 units/day if HbA1c at Visit 1 is >8.5%.

- Patients receiving 1 or 2 of the following oral anti-diabetic (OAD) drugs: metformin,
pioglitazone/rosiglitazone, an SGLT-2 inhibitor or a sulfonylurea (SU), at stable
doses for at least 12 weeks prior to Visit 1.

Exclusion criteria:

- Age <18 years of age at Visit 1.

- A body mass index (BMI) ≤20 or >40 kg/m2 at Visit 1.

- Fasting plasma glucose (FPG) >200 mg/dL (by central lab measurement) at Visit 1
(1-time repeat measurement before Visit 2 is permitted).

- Type 1 DM or any diabetes other than T2DM.

- Any use of OAD drugs other than those described in the inclusion criteria (e.g., but
not limited to, glucagon like peptide-1 receptor agonist (GLP-1 RA), dipeptidyl
peptidase 4 (DPP4) inhibitors) within 12 weeks prior Visit 1.

- Use of any other type of insulin except for basal insulin (e.g., prandial or premixed
insulin, insulin pump) within 6 months prior to Visit 1. Note: History of short-term
treatment (ie, ≤10 days) with other insulin types due to intercurrent illness is
permitted at the discretion of the Investigator.

- Known history of discontinuation of treatment with a GLP-1 RA due to
safety/tolerability reasons.

- Use of systemic glucocorticoids for a total duration of >7 days within 12 weeks prior
to Visit 1.

- Initiation/change in type or dose of a weight loss drug within 12 weeks prior to Visit
1.

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