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This is a Phase 2a study designed to assess the effect of NLY01 in patients with type 2 diabetes. Patients will be monitored for safety, pharmacokinetics, and pharmacodynamic effects on glycemic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NLY01 (2.5 mg) | Active Comparator |
| |
| NLY01 (5.0 mg) | Active Comparator |
| |
| NLY01 (10 mg) | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NLY01 | Drug | NLY01, a PEGylated form of the anti-diabetic peptide exenatide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment Emergent Adverse Events | 35 days | |
| Number of Incidences of Adverse Events | 35 days | |
| Plasma glucose | Change of fasting glucose profiles | 24 hours |
| Change in serum insulin | Change in 24 hour serum insulin | 24 hours |
| Change in plasma glucagon | Change in 24 hour plasma glucagon concentrations | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Lee | Neuraly, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institute fur Stoffwechselforschung GmbH | Neuss | D-41460 | Germany | |||
| Profil Institute |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Drug | normal saline |
|
| Neuss |
| D-41460 |
| Germany |
| D004700 | Endocrine System Diseases |