Quantitative 18F-AV-133 PET Imaging in Subjects With Diabetes and Healthy Controls

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: 10% Arginine Hydrochloride-R-Gene 10; Drug: 18F-AV-133

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arginine Stimulation Testing; Establish the methodology for glucose enhanced arginine stimulation testing (AST).	Drug: 10% Arginine Hydrochloride-R-Gene 10
Experimental: PET Imaging; 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).	Drug: 10% Arginine Hydrochloride-R-Gene 10; Drug: 18F-AV-133; 296 MBq (8 mCi)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Avid Radiopharmaceuticals
• Collaborators: Pfizer

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: October 17, 2012
• First Submitted That Met QC Criteria: October 17, 2012
• First Posted (Estimate): October 19, 2012

Study Record Updates

• Last Update Posted (Estimate): November 13, 2015
• Last Update Submitted That Met QC Criteria: November 12, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: A9001458

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No