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:
2025-12-26 @ 3:58 PM
Ignite Modification Date:
2025-12-26 @ 3:58 PM
NCT ID:
NCT06945406
Eligibility Criteria:
Inclusion Criteria:
Part A for Healthy Participants:
* Are overtly healthy as determined by medical evaluation, including medical history, physical exam, laboratory tests, and cardiac screening assessment
Part A for Type 2 Diabetes (T2DM) Participants:
* Are participants with T2DM diagnosed greater than 1 year before enrollment,
* On basal insulin therapy, insulin glargine, or insulin degludec, greater than 10 units per day for at least 6 months (for Cohort 5 only)
* Glycated hemoglobin (HbA1c) 6.5% to 9.5% inclusive at screening
Part B
* Have Type 1 Diabetes (T1D) for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol/L) or less or non-fasting C-peptide level of 0.30 nmol/L or less at screening
* HbA1c 6% to 8.5% inclusive at screening
Part C
* Have T1D for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol/L) or less or non-fasting C-peptide level of 0.30 nmol/L or less at screening
* HbA1c 6 to 8% inclusive at screening
All Parts
* Have blood pressure of less than 140/90 millimeters of mercury (mmHg) for healthy participants or 150/90 mmHg for participants with diabetes and pulse rate of less than 90 beats per minute (bpm) (supine)
* No hypoglycemia unawareness for all Type 1 and Type 2 Diabetes participants
Exclusion Criteria:
* Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening
* Have had any episodes of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within the 6 months prior to screening
All Parts
* Cardiovascular: no significant history of cardiovascular disease (CVD)
* Gastrointestinal: have gastroparesis or have undergone gastric surgery
* Hepatic: have acute or chronic hepatitis
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06945406
Study Brief:
Protocol Section:
NCT06945406