Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes

Inclusion Criteria:

• Individuals ≥18 years

• Diagnosed T1DM with a minimum of 5 years since diagnosis

• Has had at least 1 hypoglycemic event of Level 2 (glucose level <54 mg/dL or <3mmol/L, [CGM or SMBG confirmed]) or Level 3 (defined as a severe hypoglycemia withaltered mental state and/or physical status requiring assistance) in the last 2months prior to Screening

• HbA1c value of <9.5% at Screening

• Is currently on CSII (closed-loop systems are prohibited) or is on MDI for at least 6 months prior to the Screening Visit and is willing to stay on same type of insulintreatment and the current mode of insulin administration (CSII or MDI injectiontreatments) for the duration of the study

• Must have used a CGM device for at least 3 consecutive months prior to Screening

Exclusion Criteria:

• Has T2DM, monogenic diabetes, maturity-onset diabetes of the young, other unusual orrare forms of diabetes mellitus, or diabetes resulting from a secondary disease

• Has been hospitalized for DKA within 3 months prior to Screening

• Has uncontrolled hypothyroidism or hyperthyroidism

• History of eating disorder within the last 2 years such as anorexia, bulimia,diabulimia or neglecting to give insulin to manipulate weight

• Has an active or untreated malignancy, or has been in remission from malignancy for ≤5 years except well-treated basal cell or squamous cell skin cancer or cervicalcancer in situ

• Has used any of the following medications within the specified time periods - anynon- insulin anti-diabetic therapies, e.g., sodium glucose cotransporter-2 (SGLT-2)inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, metformin,sulfonylureas, dipeptidyl peptidase 4 (DPP-4) inhibitors, or pramlintide within 90days prior to the Screening or weight loss medications within 30 days prior to theScreening

• Has used a hybrid closed-loop system (e.g., Medtronic 670G, Omnipod 5, or Tandem X2with control IQ) or Do-It-Yourself looping within the last 1 month prior to theScreening Visit, and agrees to not start hybrid closed-loop systems orDo-It-Yourself looping during the study.

• Has an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 utilizing theChronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening

• Has persistent, uncontrolled hypertension prior to Screening