A Study Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®)

Inclusion Criteria:

- Established clinical diagnosis of type 1 diabetes, consistent with ADA classification
criteria (Diabetes Care 35: S64-S71, 2012), for more than 1 year.

- Age: 18 years old, or older.

- Body Mass Index: between 18 and 35 kg/m2, inclusive.

- Willing to use insulin glargine as the only basal insulin throughout the duration of
the trial.

- Willingness not to use insulin pump treatment and only use the study glucose meter
and CGM devices during the duration of the trial.

Exclusion Criteria:

- History of known hypersensitivity to any of the components in the study medication

- Treatment with pramlintide or GLP-1 analogs within 30 days of screening or
anticipated use of these medications during the course of the study.

- Treatment with oral or intravenous corticosteroids in the last 3 months prior to
screening. Standard doses of inhalational corticosteroid used as part of a long term
treatment regimen are allowed.

- Consistent recent hypoglycemic unawareness within the last six months

- History of more than two severe hypoglycemic events within six months prior to
screening