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 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT02197520
Eligibility Criteria:
Inclusion Criteria:
* Stable glycated hemoglobin (HbA1c) less than (\<) 10.0 percent (%)
* Stable dose of either 0.2 to 1.5 units per kilogram per day (U/kg/day) basal insulin or a total daily insulin dose l\<2.0 units per kilogram (U/kg)
* C-peptide \<0.3 nanomole per liter (nmol/L)
* Stable body during the last 2 months
Exclusion Criteria:
* Corrected QT interval (QTc) prolongation greater than (\>) 500 milliseconds (ms) or have any other abnormality in the 12 lead
* Abnormal blood pressure
* A history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from Type 1 Diabetes Mellitus (T1DM)), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
* Currently treated with oral antidiabetic drugs (OADs) (excluding metformin and dipeptidyl peptidase-4 (DPP4) inhibitors), or glucagon-like peptide-1 (GLP-1) agonists or intend to use over-the counter or prescription medication, herbal medications, or nutritional supplements that affect PG or insulin sensitivity, impact on hypoglycemic awareness or promote weight loss within 4 weeks prior to randomization
* Fasting triglycerides (TGs) \>400 milligrams per deciliter (mg/dL) (4.52 millimoles per liter (mmol/L))
* Have used systemic or inhaled corticosteroids/glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations) within 4 weeks prior to randomization
* Currently receive insulin by pump or insulin degludec
* Poorly controlled diabetes or known to have poor awareness of hypoglycemia
* History of gastroparesis or gastrointestinal malabsorption
* Require treatment with any drug other than insulin to treat diabetes
* Previous history of proliferative retinopathy
* Excessive consumers of xanthines
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02197520
Study Brief:
Protocol Section:
NCT02197520