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 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 1:03 AM
NCT ID:
NCT02715193
Eligibility Criteria:
Inclusion Criteria:
* Men and women between the ages of 18 and 60 years old, inclusive, at the time of screening;
* Females of non-child bearing potential must be ≥1 year post-menopausal (confirmed by a serum follicle-stimulating hormone (FSH) levels ≥ 40 IU/mL) or documented as being surgically sterile. Females of child bearing potential must agree to use two methods of contraception;
* Male subjects must be willing to use clinically acceptable method of contraception during the entire study;
* Body mass index between 18.5 and 26.9 kg/m2, inclusive, at screening;
* Diagnosed with Type 1 diabetes for greater than 2 years, based on clinical history or as defined by the current American Diabetes Association (ADA) criteria;
* HbA1c ≥6.0 % but \<9.0 % at screening;
* Fasting C-peptide \<0.2 ng/mL;
* Current use of insulin pump and willing to use continuous glucose monitoring (CGM) system (e.g. DexCom) throughout the entire study;
* ALT and/or AST within \<1.5x ULN at screening;
* Serum amylase and lipase within normal limits at screening;
* Able to provide written informed consent approved by an Institutional Review Board (IRB).
Exclusion Criteria:
* History or evidence of clinically-significant disorder or condition that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
* Significant organ system dysfunction (e.g., clinically significant pulmonary or cardiovascular disease, anemia \[Hemoglobin \<10.0 g/dL\], and renal dysfunction \[eGFR \<90 ml/1.73M2/min\]);
* Any severe symptomatic hypoglycemic event associated with a seizure or requiring help from other people or medical facility in the past 6 months;
* Current or recent (within 1 month of screening) use of diabetes medications other than insulin;
* Use of steroids and/or other prescribed or over-the-counter medications that are known to affect the outcome measures in this study or known to influence glucose metabolism;
* Smokes tobacco;
* Known sensitivity to mammalian-derived drug preparations, recombinant protein-based drugs or to humanized or human antibodies;
* History of illegal drug use or alcohol abuse within the last 6 months or a positive drug urine test result at screening;
* History of pancreatitis, pancreatic neuroendocrine tumors or multiple endocrine neoplasia;
* History of pheochromocytoma, or family history of familial pheochromocytoma;
* Known or suspected susceptibility to infectious disease (eg, taking immunosuppressive agents or has a documented inherited or acquired immunodeficiency);
* Positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HbsAg), or hepatitis C antibodies (HepC Ab);
* Participation in an investigational drug or device trial within 30 days of screening or within 5 times the half-life of the investigational agent in the other clinical study, if known, whichever period is longer;
* Blood donor or blood loss \>500 mL within 30 days of Day 1;
* Women who are pregnant or lactating/breastfeeding;
* Regular exercise \>120 min/week within 14 days of Day 1;
* Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits;
* Family history of multiple endocrine neoplasia.
Other inclusion and exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02715193
Study Brief:
Protocol Section:
NCT02715193