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:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2025-12-24 @ 6:54 PM
NCT ID:
NCT01762657
Eligibility Criteria:
Inclusion Criteria:
1. They are male or female, 8-60 years of age
2. They have a history of onset of type 1 Diabetes Mellitus at or before 20 years of age; or have documentation of autoimmunity testing to the pancreas to include one of more of the following tests
* Islet-cell autoantibodies 512 (ICA512)/islet antigen-2 (IA-2),
* Glutamic Acid Decarboxylase (GAD) autoantibodies, or
* Insulin autoantibodies (in subjects on insulin for more than 2 weeks, ICA512/IA-2 or GAD must be positive)
3. They have a C-peptide of greater than or equal to to 0.6 ng/mL (0.2 nmol/L)
4. They have a Hemoglobin A1C levels of less than 9%
5. They are able and willing to participate in the study, as evidenced by providing written informed consent
6. Females must be post-menopausal (at least 1 year without spontaneous menses) or surgically sterile (tubal ligation or hysterectomy at least 6 months prior to enrollment), or to have a negative pregnancy test and practice acceptable contraception \[e.g., oral, intramuscular, or implanted hormonal contraception, sexual partner with nonreversed vasectomy (with azoospermia in 2 tests), 2 barrier methods (e.g., condom, diaphragm, or spermicide), or intrauterine device\]. Females of childbearing potential must undergo pregnancy testing within 24 hours prior to administration of the first dose of study drug.
Exclusion Criteria:
1. Prior administration of immune tolerance therapy or immune tolerance clinical trial for type 1 diabetes
2. Participation in any type of therapeutic drug or vaccine clinical trial within the last 12 weeks before randomization at Study Day 0
3. Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
4. Pregnant females or lactating females who intend to provide their own breast milk to the baby during the study
5. Current therapy with GLP-1 receptor agonists (e.g., exenatide or pramlintide), or any other agents that might stimulate pancreatic beta cell regeneration or insulin secretion
6. Current treatment with oral antidiabetic agents
7. Evidence of active or latent tuberculosis
8. Vaccination with a live virus or organism within the 8 weeks before randomization continuing through week 52 of the study
* Influenza vaccination with a killed virus, including booster vaccinations, within 4 weeks before or after each dosing cycle
* Vaccination with other antigens or killed organisms within 8 weeks before or after each dosing cycle
9. Systolic or diastolic blood pressure \>150 mmHg and 90 mmHg, respectively, as measured by an appropriately sized cuff;
10. A body mass index (BMI) \>28 kg/m2
11. Worsening retinopathy, angina, or congestive heart failure
12. A history or presence of acute or chronic pancreatitis
13. A history or presence of any illness, disease, or condition that could impact patient safety or evaluability of drug effect, in the Investigator's opinion
14. An episode of severe hypoglycemia (defined as a change in mental status requiring assistance) during the prior 30 days
15. An episode of diabetic ketoacidosis during the prior 6 months
16. Received any new hypoglycemic medications within the past 3 months
17. An aspartate transaminase (AST), alanine transaminase (ALT), or total bilirubin level \>2 times the upper limit of normal (ULN)
18. A blood urea nitrogen (BUN) level \>50 mg/dL or a serum creatinine level \>1.4 mg/dL
19. A serum amylase level \>1.5 times the ULN or a serum lipase level \>2 times the ULN
20. A history of substance abuse or dependence in the past year as defined by the Diagnostic and Statistical Manual of Mental Disorders, (DSM V) criteria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
60 Years
Study:
NCT01762657
Study Brief:
Protocol Section:
NCT01762657