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

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: 10% Arginine Hydrochloride-R-Gene 10; Drug: 18F-AV-133

• Registration Number: NCT01710371
• Lead Sponsor: Avid Radiopharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-17
• Study First Submitted QC: 2012-10-17
• Study First Posted: 2012-10-19
• Study Start: 2012-12
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-12
• Last Update Posted: 2015-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arginine Stimulation Testing	10% Arginine Hydrochloride-R-Gene 10	Establish the methodology for glucose enhanced arginine stimulation testing (AST).
PET Imaging	10% Arginine Hydrochloride-R-Gene 10	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).
PET Imaging	18F-AV-133	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).

Primary Outcome Measures

Name	Time	Method
Optimal PET-determined mean pancreatic Volume of Distribution (VT) of 18F-AV-133	PET visit 1
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 New Haven, Connecticut, United States