A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone

Inclusion Criteria:

- Patient has given written informed consent to participate in the study in accordance
with local regulations

- Adult patients 18 years and older with a diagnosis of T1DM made at least 1 year prior
to informed consent

- Patients are being treated with insulin or insulin analog

- Willing and able to perform self-monitoring of blood glucose (SMBG) and complete the
study diary as required per protocol

- At the Screening Visit, A1C must be between 7.0% to 11.0%

- Females of childbearing potential must use an adequate method of contraception and
have a negative pregnancy test

Exclusion Criteria:

- Use of antidiabetic agent other than insulin or insulin analog at the time of
screening

- Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to
screening

- Chronic systemic corticosteroid use

- Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the
Investigator