Type 2 Diabetes (T2D) Clinical Trials

• Participants who meet the criteria of T1D according to American Diabetes Association

• Initiated exogenous insulin replacement therapy not longer than 90 days prior to screening visit at which random C-peptide will be assessed (V1).

• Receiving at least one of the following T1D standard of care (SOC), insulin hormone replacement therapy

‣ one or multiple daily injections (MDI) of basal insulin, prandial insulin and/or premixed insulin, or

⁃ continuous subcutaneous insulin infusion (CSII)

• Participants must be positive for at least 1 of the following T1D autoantibodies confirmed by medical history and/or obtained at study screening:

‣ Glutamic acid decarboxylase (GAD-65)

⁃ Insulinoma Antigen-2 (IA-2)

⁃ Zinc-transporter 8 (ZnT8) or

⁃ Insulin (if obtained not later than 10 days after exogenous insulin therapy initiation)

• Have random C-peptide levels ≥ 0.2 nmol/L determined at screening visit.

• Be vaccinated according to the local vaccination schedule. Any vaccinations should take place at least 28 days prior to randomization for non-live vaccines and at least 3 months prior to randomization for live vaccines.

• Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies