Assessment of Safety, Tolerability and Drug Levels of NPM-119 in Participants With Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability and drug levels of an exenatide implant (NPM-119) for the treatment of type 2 diabetes

Official Title
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A Randomized, Parallel-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of NPM-119 (Exenatide Implant) in Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Combination Product: NPM-119 (exenatide implant)
* Drug: Bydureon BCise (exenatide extended release)


Participation Criteria
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Eligibility Criteria
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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 <8.5 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPM-119<br>One NPM-119 implant that delivers approximately 52 microgram/day of exenatide for a duration of 12 weeks will be inserted subdermally just under the skin of the upper outer arm. | Combination Product: NPM-119 (exenatide implant)<br>* NPM-119 is a drug:device combination that delivers steady levels of exenatide, a glucagon-like peptide-1(GLP-1) receptor agonist, for an extended period of time following subdermal insertion.<br>|
| Active Comparator: Bydureon BCise (exenatide extended release)<br>2 mg subcutaneous injection every week for a duration of 12 weeks | Drug: Bydureon BCise (exenatide extended release)<br>* glucagon-like peptide-1 (GLP-1) receptor agonist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration-time curve (AUC) | Total exenatide concentration | 12 weeks | 
| Maximum plasma concentration observed (Cmax) | Maximal exenatide concentration | 12 weeks | 
| Time to maximum plasma concentration observed (Tmax) | Time to reach maximal exenatide concentration | 12 weeks | 
| Adverse events | Incidence of treatment-emergent adverse events | 12 weeks |