Efficacy and Safety of Toujeo® Versus Tresiba® in Insulin-Naive Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist

The maximum study duration per participant was approximately 27 weeks: an up to 2-week
screening period, a 24-week randomized treatment period (including 12 weeks active
titration), and a 7-day posttreatment safety follow-up period.

Inclusion criteria :

- Adult participants with type 2 diabetes mellitus (T2DM) inadequately controlled with
OADs therapy with/without GLP-1 receptor agonist at stable dose for at least 3 months.

- Signed written informed consent.

Exclusion criteria:

- Age <18 years.

- HbA1c <7.5% or >10.5% (at screening visit). Body mass index (BMI) <25 kg/m^2 or >40
kg/m^2.

- History of T2DM for less than 1 year before screening.

- Less than 6 months before screening on OADs treatment and GLP-1 receptor agonist (if
taken).

- Current or previous insulin use except for a maximum of 8 consecutive days or totally
15 days (eg, acute illness, surgery) during the last year prior to screening.

- Initiation of new glucose-lowering medications and/or weight loss drug in the last 3
months before screening visit.

- Participant receiving only noninsulin antihyperglycemic drugs not approved for
combination with insulin according to local labelling/local treatment guideline.

- History of hypoglycemia unawareness or repeated episodes of severe hypoglycemia or
metabolic acidosis, including hospitalization for diabetic ketoacidosis during the
last 12 months prior to screening.

- Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic
retinopathy or macular edema likely to require treatment (eg, laser, surgical
treatment, or injectable drugs) during the study period.

- End stage renal disease.

- Any acute or chronic condition that in the opinion of Investigator would affect the
safety of participant, compliance, or study results.

- Any contraindication to use of Toujeo® or Tresiba® as defined in the national product
label, hypersensitivity to Toujeo® or Tresiba® active ingredients or one of the
excipients.

- Pregnant or breast-feeding women.

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