Type 2 DiabetesPhase 1NCT01710371
Quantitative 18F-AV-133 PET Imaging in Subjects With Diabetes and Healthy Controls
A Phase 1 study testing 18F-AV-133 and 10% Arginine Hydrochloride-R-Gene 10 in people with Type 2 Diabetes, run by Avid Radiopharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- 18F-AV-133 and 10% Arginine Hydrochloride-R-Gene 10
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Sep 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Healthy Overweight
- Pre-diabetes
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes
- Being tested
- 18F-AV-133, 10% Arginine Hydrochloride-R-Gene 10
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-AV-133Drug
296 MBq (8 mCi)
10% Arginine Hydrochloride-R-Gene 10Drug
| Study group | Role | What they receive |
|---|---|---|
| Arginine Stimulation Testing | Experimental | Establish the methodology for glucose enhanced arginine stimulation testing (AST). Receives: Drug: 10% Arginine Hydrochloride-R-Gene 10 |
| 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). Receives: Drug: 18F-AV-133; Drug: 10% Arginine Hydrochloride-R-Gene 10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal PET-determined mean pancreatic Binding Potential of 18F-AV-133
Measured: PET visit 1
Optimal PET-determined mean pancreatic Standardized Uptake Value (SUV) of 18F-AV-133
Measured: PET visit 1
Optimal PET-determined mean pancreatic Volume of Distribution (VT) of 18F-AV-133
Measured: PET visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avid Radiopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Avid Radiopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710371
- Sponsor's protocol ID
- A9001458
- Status last verified
- Nov 2015
- First submitted
- 17 Oct 2012
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01710371
- Acronym / sponsor ID
- A9001458
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Dec 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arginine Stimulation Testing | Experimental | Drug: 10% Arginine Hydrochloride-R-Gene 10Establish the methodology for glucose enhanced arginine stimulation testing (AST). |
| PET Imaging | Experimental | Drug: 18F-AV-133, Drug: 10% Arginine Hydrochloride-R-Gene 10Determine 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). |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-AV-133296 MBq (8 mCi) | Drug | PET Imaging |
| 10% Arginine Hydrochloride-R-Gene 10 | Drug | Arginine Stimulation Testing, PET Imaging |
Primary outcome
Optimal PET-determined mean pancreatic Binding Potential of 18F-AV-133
Time frame: PET visit 1
Optimal PET-determined mean pancreatic Standardized Uptake Value (SUV) of 18F-AV-133
Time frame: PET visit 1
Optimal PET-determined mean pancreatic Volume of Distribution (VT) of 18F-AV-133
Time frame: PET visit 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Medical Officer study director
Avid Radiopharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 18F-AV-133 and 10% Arginine Hydrochloride-R-Gene 10 in people with Type 2 Diabetes, run by Avid Radiopharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal PET-determined mean pancreatic Binding Potential of 18F-AV-133 (time frame: PET visit 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2015.