Assessment of Safety, Tolerability and Drug Levels of NPM-119 in Participants With Type 2 Diabetes (LIBERATE-1)
Type 2 Diabetes
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes BMI up to 40 kg/m^2 Estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m^2 HbA1c >/= 6.5 and <10.0 Treated with a stable regimen of a GLP-1receptor agonist other than exenatide-containing drugs for a minimum of 3 months Exclusion Criteria: Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being History of, or currently has, acute or chronic pancreatitis or has triglyceride concentrations ≥500 mg/dL Has medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN II) or a family history of MTC or MEN II Current or past exposure to exenatide Sulfonylurea (SU) use within the prior 3 months Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide within the previous 30 days Insulin use within the previous 3 months; glucocorticoid use at a dose >20 mg/day of prednisone
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
NPM-119
Bydureon BCise (exenatide extended release)
One NPM-119 implant that delivers approximately 52 microgram/day of exenatide for a duration of 3 months will be inserted subdermally just under the skin of the upper outer arm.
2 mg subcutaneous injection every week for a duration of 3 months