Phase II Pharmacokinetics Study of Humalog and Humulin-R With and Without rHuPH20 in Type 1 Diabetes Mellitus

Exclusion Criteria

• •Known or suspected allergy to any component of any of the study drugs in this trial.
• •Previous enrollment in this trial.
• •A participant who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.
• •Clinically significant (as judged by the Investigator) active disease of the gastrointestinal, cardiovascular (including a history of arrhythmia or conduction delays on electrocardiogram \[ECG\]), hepatic, neurological, renal, genitourinary, or hematological systems, or uncontrolled hypertension (diastolic blood pressure greater than or equal to 100 millimeters of mercury \[mmHg\] and/or systolic blood pressure greater than or equal to 160 mmHg after 5 minutes in the supine position).
• •History of any illness or disease that in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the study drugs to the participant.
• •Clinically significant findings (as judged by the Investigator) in routine laboratory data, including anemia with hemoglobin less than lower limits of normal at screening.
• •Use of drugs which may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia.
• •Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the Investigator.
• •Current addiction to alcohol or substances of abuse as determined by the Investigator.
• •Blood donation (\>500 milliliters \[mL\]) within the 9 weeks prior to first day of dosing on study.
• •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 or barrier methods).
• •Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation.
• •Symptomatic gastroparesis.
• •History or evidence of use of any tobacco- or nicotine-containing product within 6 months of screening or screening quantitative urine nicotine concentration \>50 ng/mL.
• •Receipt of any investigational drug within 4 weeks of first day of dosing in this study.
• •Any condition (intrinsic or extrinsic) that in the judgment of the Investigator will interfere with trial participation or evaluation of data.