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

Avid Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: 18F-AV-133; Drug: 10% Arginine Hydrochloride-R-Gene 10

Study type: Interventional

Funder types: Industry

Identifiers

NCT01710371

A9001458

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Arginine Stimulation Testing

Experimental group

Description:

Establish the methodology for glucose enhanced arginine stimulation testing (AST).

Treatment:

Drug: 10% Arginine Hydrochloride-R-Gene 10

PET Imaging

Experimental group

Description:

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).

Treatment:

Drug: 10% Arginine Hydrochloride-R-Gene 10

Drug: 18F-AV-133