CONSISTENT 1: Metabolic and Safety Outcomes of Hylenex Recombinant (Hyaluronidase Human Injection) Preadministered at CSII Infusion Site in Participants With Type 1 Diabetes Mellitus (T1DM)

This Phase 4 study is designed to demonstrate noninferiority of pretreatment with Hylenex
recombinant in the CSII setting to rapid-acting analog insulin alone with respect to glycemic
control as assessed by changes in HbA1c in participants with Type 1 diabetes mellitus.

Total duration of study treatment is 24 months. However, according to the study design, the
primary outcome measure is to be assessed at 6 months and an interim analysis is to be
completed at 6 months for the secondary outcome measures and adverse events. Therefore, data
reported in this clinical trials record is for the 6-month interim analysis.

Inclusion Criteria:

1. Male or female of age 18 years or older with a history of T1DM for at least 12 months

2. Glycosylated hemoglobin (HbA1c) 6.5% to 9.5% (inclusive) based on central laboratory
results

3. Fasting C-peptide <0.6 nanograms per milliliter (ng/mL)

4. Current use of an insulin pump compatible with available tubing for Hylenex
recombinant infusion and use of an infusion set compatible with the tubing available
or willingness to switch to an infusion set compatible with tubing available for
infusion of Hylenex recombinant

5. Current treatment at the time of screening with insulin <300 units per day (U/day)

6. Participants who routinely use continuous glucose monitoring (CGM) (defined as average
CGM use 5 or more days per week over the preceding 3 months) and those who do not
routinely used CGM are both eligible for inclusion in the study. Intermittent use of
CGM is also acceptable but will not be a criterion use for stratified randomization.

7. Participants should be in good general health based on medical history and physical
examination, without medical conditions that might prevent the completion of study
drug infusions and assessments required in this protocol.

Exclusion Criteria:

1. Type 2 diabetes

2. Known or suspected allergy to any component of any of the study drugs in this study

3. Severe proliferative retinopathy or maculopathy, and/or gastroparesis, and/or severe
neuropathy, in particular autonomic neuropathy, of such severity as to impede the
participant's ability to comply with protocol procedures, as judged by the
Investigator

4. History of transmural myocardial infarction, congestive heart failure and uncontrolled
hypertension (diastolic blood pressure [BP] consistently >100 millimeters of mercury
[mmHg]) are exclusionary

5. As judged by the Investigator, clinically significant active disease of the
gastrointestinal, cardiovascular (including history of stroke, history of arrhythmia,
or conduction delays on electrocardiogram [ECG]), hepatic, neurological, renal,
genitourinary, pulmonary, or hematological systems of such severity as to impede the
participant's ability to comply with protocol procedures

6. History of any illness or disease that in the opinion of the Investigator might
confound the results of the study or pose additional risk in administering the study
drugs to the participant

7. As judged by the Investigator, clinically significant findings in routine laboratory
data at screening

8. Use of drugs that may interfere with the interpretation of study results or are known
to cause clinically relevant interference with hyaluronidase action, insulin action,
glucose utilization, or recovery from hypoglycemia (including systemic pharmacologic
corticosteroid). Use of pramlintide or a glucagon-like peptide [GLP]-1 receptor
agonist is not exclusionary but participants using these agents will be subjected to
stratified randomization. Use of aspirin (acetylsalicylic acid [ASA]) up to 325
milligrams (mg)/day is not exclusionary but should be noted for analysis.

9. Hypoglycemic unawareness of such severity as to impede the participant's ability to
comply with protocol procedures, as judged by the Investigator.

10. Current addiction to alcohol or substance abuse as determined by the Investigator.

11. Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate
contraceptive measures (adequate contraceptive measures consist of sterilization,
intra-uterine device [IUD], oral or injectable contraceptives, and/or barrier
methods). Abstinence alone is not considered an adequate contraceptive measure for the
purposes of this study.

12. Mental incapacity, unwillingness, or language barriers precluding adequate
understanding or cooperation in this study