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NCT05670379
Assessment of Safety, Tolerability and Drug Levels of NPM-119 in Participants With Type 2 Diabetes
Conditions: Type 2 Diabetes
Sex: All
Ages: 18 Years – 70 Years
Phase: PHASE2
Enrollment: 48
Sponsor: Vivani Medical, Inc
Summary
The purpose of this study is to evaluate the safety, tolerability and drug levels of a 3-month exenatide implant (NPM-119) for the treatment of type 2 diabetes
Eligibility Criteria
Inclusion Criteria:Type 2 diabetesBMI up to 40 kg/m^2Estimated glomerular filtration rate (eGFR) >60 mL/min/1.73
m^2HbA1c >/= 6.5 and <10.0Treated with a stable regimen of a GLP-1receptor agonist other than exenatide-containing drugs for a minimum of 3 monthsExclusion Criteria:Has a clinically significant medical condition that could potentially affect study participation and/or personal well-beingHistory of, or currently has, acute or chronic pancreatitis or has triglyceride concentrations ≥500 mg/dLHas medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN II) or a family history of MTC or MEN IICurrent or past exposure to exenatideSulfonylurea (SU) use within the prior 3 monthsAlpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide within the previous 30 daysInsulin use within the previous 3 months; glucocorticoid use at a dose >20 mg/day of prednisone
Source: ClinicalTrials.gov (NCT05670379). StuddyBuddy aggregates publicly available trial information.