Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec

Inclusion Criteria:

• clinical diagnosis Type 1 diabetes with C-peptide <=0.6 ng/mL and using insulin forat least 6 months

• willing to use study provided insulin as the only bolus insulin and insulin degludecas the basal insulin

• willing to use CGM device throughout the study

• screening A1C >= 6.5% and <= 10.0% daily insulin dose <= 1.25 U/kg/day

Exclusion Criteria:

• known or specific allergy to any component of the study drug, the active comparator

• pregnant or breast-feeding, or plans to become pregnant at any time during durationof study

• current use of hydroxyurea

• use of noninsulin glucose-lowering medications other than metformin, weight lossmedications or dietary supplements for weight loss within 30 days, or anticipateduse during the course of the study

• received any investigational drug within prior 30 days

• Clinically significant abnormalities on screening laboratory testing including liverenzymes

• Presence of a medical condition or use of a medication that could compromise theresults of the study or the safety of the subject (eg. alcohol or drug abuse,uncontrolled hypertension, history of transient ischemic attack or stroke within thelast 12 months)

• employed by or having immediate family members employed by the sponsor or directlyinvolved in conducting the clinical trial.