Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT03662334
Eligibility Criteria:
Inclusion Criteria:
1. Male or female participants between the ages 18 and 65 years, inclusive.
2. Females of child-bearing potential must agree to use a standard and effective means of birth control for the duration of the study. Adequate contraceptive measures include oral or injectable contraceptives, sterilization, intra-uterine device (IUD), barrier methods, or abstinence.
3. Participants with type 1 diabetes mellitus treated with insulin (multiple daily injections or continuous subcutaneous insulin infusion \[CSII\]) diagnosed ≥ 12 months prior to enrollment
4. Body mass index (BMI) 18.0 to 32.0 kilograms per meters squared (kg/m\^2)
5. HbA1c (glycated hemoglobin A1c) ≤ 10% based on local laboratory results
6. Fasting C-peptide \< 0.6 nanograms per milliliter (ng/mL)
7. Current treatment with insulin \<1.2 Units per kg per day (U/kg/day)
8. Participant should be in good general health based on medical history and physical examination, without medical conditions that might prevent the completion of study drug injections and assessments required in this protocol
Exclusion Criteria:
1. Inability to comply with study requirements as judged by the Investigator
2. Known or suspected allergy to any component of any of the study drugs in this trial
3. A participant who has proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
4. As judged by the Investigator, clinically significant active disease of the gastrointestinal, cardiovascular (including a history of arrhythmia or conduction delays on electrocardiogram), hepatic, neurological, renal, genitourinary, or hematological systems
5. As judged by the Investigator, uncontrolled hypertension (diastolic blood pressure ≥ 100 millimeters of mercury \[mmHg\] and/or systolic blood pressure ≥ 160 mmHg after 5 minutes in the supine position)
6. 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
7. As judged by the Investigator, clinically significant findings in routine laboratory data. Anemia with hemoglobin less than lower limits of normal at screening is specifically exclusionary
8. Use of drugs that 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, or drugs not permitted according to Hylenex recombinant package insert
9. Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the Investigator
10. Current addiction to alcohol or substances of abuse as determined by the Investigator
11. Blood donation (\> 500 mL) within the previous 8 weeks (56 days) prior to Day -1 of Treatment Period 1
12. Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, IUD, oral or injectable contraceptives, or barrier methods)
13. Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation in this study
14. Participation in any other clinical trial and receipt of any investigational drug within 4 weeks of Day -1 of Treatment Period 1
15. Any condition (intrinsic or extrinsic) that in the judgment of the Investigator will interfere with trial participation or evaluation of data
16. Positive for human immunodeficiency virus (HIV), Hepatitis C or Hepatitis B
17. Tobacco and nicotine use within 3 months prior to Day 1 of Treatment Period 1 or use during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03662334
Study Brief:
Protocol Section:
NCT03662334