Quantitative 18F-AV-133 PET Imaging in Subjects With Diabetes and Healthy Controls
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 30 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | December 2012 |
| End Date: | September 2015 |
Quantitative PET Imaging of Pancreatic Beta-Cell Mass in Healthy Overweight/Obese Subjects, Subjects With Prediabetes, and Type 2 Diabetes Patients With 18F-FP-DTBZ (18F-AV-133)
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.
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.
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
1. Healthy Overweight
2. Pre-diabetes
3. T2DM
- (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:
- Subjects who are affiliated with or relatives of staff members of either the site or
Pfizer directly involved in the conduct of the trial.
- Conditions which in the opinion of the study investigator may interfere with the
subject's ability to participate in the study
- History of allergic reaction to drug/contrast agent or history of drug/alcohol abuse
- Subjects who have received investigational medications within the last 30 days or a
radiopharmaceutical in the past 7 days.
- Pregnant or nursing females; females of childbearing potential.
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