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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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To evaluate 18F-AV-133 imaging of the pancreas in patients with early type 2 diabetes, late type 2 diabetes, subjects with pre-diabetes and in healthy overweight/obese control subjects. These subjects will also be evaluated for beta-cell function as measured by the insulin and C-peptide response to a challenge with intravenous arginine under basal and glucose enhanced conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arginine Stimulation Testing | Experimental | Establish the methodology for glucose enhanced arginine stimulation testing (AST). |
|
| PET Imaging | Experimental | Determine if pancreatic PET-determined binding measures of 18F-AV-133 differ in up to 60 subjects determined to be at one of four stages of the natural history of Type 2 Diabetes: Healthy Overweight/obese Volunteers (HOV), Subjects with Pre-diabetes (PD) and Type 2 Diabetes mellitus (T2DM). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-AV-133 | Drug | 296 MBq (8 mCi) |
| |
| 10% Arginine Hydrochloride-R-Gene 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Optimal PET-determined mean pancreatic Binding Potential of 18F-AV-133 | PET visit 1 | |
| Optimal PET-determined mean pancreatic Standardized Uptake Value (SUV) of 18F-AV-133 | PET visit 1 | |
| Optimal PET-determined mean pancreatic Volume of Distribution (VT) of 18F-AV-133 | PET visit 1 |
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Inclusion Criteria:
Male and/or female subjects of non-childbearing potential between the ages of 30 and 65 years inclusive.
Able to tolerate PET, PET/CT and MR imaging
Estimated creatinine clearance >= 60mL/min
Informed consent documents signed and dated by subject
Subjects must be willing and able to comply with all scheduled visits, treatments laboratory tests, scans and other study procedures.
In addition, subjects must meet classification requirements for one of the following
(T2DM only) Subjects with other chronic medical conditions (besides diabetes) that are well controlled and stable on medication are acceptable for inclusion in this study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | New Haven | Connecticut | 06511 | United States |
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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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| ID | Term |
|---|---|
| C549477 | florbenazine F 18 |
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| Drug |
|
| D004700 | Endocrine System Diseases |