Diabetes Mellitus, Type 1Phase 2NCT01079325
Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy
A Phase 2 study testing SB-509 and Saline in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Sangamo Therapeutics at 31 sites in United States.
Trial summary
The purpose of the study is to evaluate the clinical effects of the investigational drug, SB-509, in subjects with diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetic Polyneuropathy
- What is being tested?
- SB-509 and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 31 sitesUnited States
- Study dates
- Nov 2009to Apr 2016
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Diabetes Mellitus Type I or II for at least 12 months
- Clinical signs and symptoms of moderate to severe diabetic sensory-motor polyneuropathy of the lower extremities for at least 6 months that are not otherwise attributed to an etiology other than diabetes
- Measurable sural and peroneal response bilaterally
- HgbA1C level ≤ 10%
- LDL cholesterol ≤ 160 mg/dL
- Blood pressure ≤ 140/90 mm Hg
- Body mass index (BMI) ≤ 38
Who cannot join
- Moderate to severe ischemic heart disease or any history of congestive heart failure, or have had a myocardial infarction within the previous 6 months
- Evidence of cardiac enlargement and/or congestive heart failure
- Current diabetic foot or leg ulcer, gangrene in the lower extremity, or any amputation of the lower extremity
- History of malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for at least 5 years
- Immune or immunodeficiency disorders or expected to require immunosuppressants for 30 days prior to, during, and for 30 days following administration of the investigational drug product
- History of or current proliferative retinopathy, macular edema or retinal neovascularization
- Pre-cancerous conditions or benign tumors which have the potential for clinically significant growth due to VEGF stimulation
- Family history of inherited neuropathy (e.g. Charcot Marie Tooth, Hereditary Predisposition to Pressure Palsy)
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Study site
Boston, Massachusetts
Study site
Boulder, Colorado
Study site
Chino, California
Study site
Dallas, Texas
Study site
DeLand, Florida
Study site
Fort Myers, Florida
Study site
Fresno, California
Study site
Greer, South Carolina
Study site
Houston, Texas
Study site
Idaho Falls, Idaho
Study site
Kansas City, Missouri
Study site
La Jolla, California
Study site
Las Vegas, Nevada
Study site
Lexington, Kentucky
Study site
Los Angeles, California
Study site
Meridian, Idaho
Study site
Miami, Florida
Study site
National City, California
Study site
Norfolk, Virginia
Study site
Orlando, Florida
Study site
Phoenix, Arizona
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
San Francisco, California
Study site
Scottsdale, Arizona
Study site
Tampa, Florida
Study site
Tucson, Arizona
Study site
Tulsa, Oklahoma
Study site
Walnut Creek, California
Study site
West Palm Beach, Florida
Study site
Winston-Salem, North Carolina
About this study
Official title: A Phase 2b Repeat Dosing Clinical Trial of SB-509 in Subjects With Moderately Severe Diabetic Neuropathy
The purpose of the study is to evaluate the clinical effects of the investigational drug, SB-509, in subjects with diabetic neuropathy.
Read the detailed description
SB-509 contains the gene (DNA-a kind of biological "blueprint") for a protein. When a researcher injects SB-509 into your legs, the drug enters the muscle and nerve cells around the injection site and causes these cells to make a protein. This protein causes your cells to increase production of another protein called vascular endothelial growth factor (VEGF), which may improve the structure and function of nerves. In addition, there are changes in the levels of additional proteins in your cells. These proteins function to promote the growth of cells, are structures in cells, help synthesize products, and affect immune cells, and some have unknown functions. This increase in your own VEGF proteins may protect and repair the damaged nerves caused by diabetic neuropathy.
- Being tested
- SB-509, Saline
- Keywords
- Diabetic neuropathy, Diabetes Type 1 or 2, Moderately severe sensorimotor diabetic polyneuropathy
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-509Drug
SB-509 60 mg, 3 treatments, and 5 months treatment period
SalineOther
Also called 30 ml saline, 3 treatments
| Study group | Role | What they receive |
|---|---|---|
| SB-509 | Experimental | Not described Receives: Drug: SB-509 |
| Placebo | Placebo comparator | Saline Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effect of SB-509 versus placebo in subjects with moderately severe diabetic neuropathy (DN) on sural Nerve Conduction Velocity (NCV) at six-months
Measured: 6 months
Secondary outcomes (3)
To evaluate the effect of SB-509 on Neuropathy Impairment Score - Lower Limb (NIS-LL), motor Nerve Conduction Velocity (NCV), Quantitative Sensory Testing (QST), Intraepidermal Nerve Fiber Density (IENFD), and Lower Extremity Neurological Sensory Exam
Measured: 12 months
To evaluate the effect of SB-509 using a multi-endpoint analysis that includes NIS-LL, Sural NCV, and IENFD
Measured: 12 months
To evaluate the safety of SB-509 in subjects with moderately severe diabetic neuropathy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startNov 2009
- Primary completionMay 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sangamo Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor
- Investigators
- Winson Tang, MD, Study director, Sangamo BioSciences, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079325
- Sponsor's protocol ID
- SB-509-0901
- Status last verified
- May 2022
- First submitted
- 2 Mar 2010
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Repeat Dosing Clinical Trial of SB-509 in Subjects With Moderately Severe Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT01079325
- Acronym / sponsor ID
- SB-509-0901
- Keywords
- Diabetic neuropathy, Diabetes Type 1 or 2, Moderately severe sensorimotor diabetic polyneuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Sangamo TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- Nov 2009
- Primary completion
- May 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 3 Mar 2010 (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.
The purpose of the study is to evaluate the clinical effects of the investigational drug, SB-509, in subjects with diabetic neuropathy.
Detailed description
SB-509 contains the gene (DNA-a kind of biological "blueprint") for a protein. When a researcher injects SB-509 into your legs, the drug enters the muscle and nerve cells around the injection site and causes these cells to make a protein. This protein causes your cells to increase production of another protein called vascular endothelial growth factor (VEGF), which may improve the structure and function of nerves. In addition, there are changes in the levels of additional proteins in your cells. These proteins function to promote the growth of cells, are structures in cells, help synthesize products, and affect immune cells, and some have unknown functions. This increase in your own VEGF proteins may protect and repair the damaged nerves caused by diabetic neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SB-509 | Experimental | Drug: SB-509 |
| Placebo | Placebo comparator | Other: SalineSaline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of Diabetes Mellitus Type I or II for at least 12 months
- Clinical signs and symptoms of moderate to severe diabetic sensory-motor polyneuropathy of the lower extremities for at least 6 months that are not otherwise attributed to an etiology other than diabetes
- Measurable sural and peroneal response bilaterally
- HgbA1C level ≤ 10%
- LDL cholesterol ≤ 160 mg/dL
Key exclusion criteria (8 listed)
- Moderate to severe ischemic heart disease or any history of congestive heart failure, or have had a myocardial infarction within the previous 6 months
- Evidence of cardiac enlargement and/or congestive heart failure
- Current diabetic foot or leg ulcer, gangrene in the lower extremity, or any amputation of the lower extremity
- History of malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for at least 5 years
- Immune or immunodeficiency disorders or expected to require immunosuppressants for 30 days prior to, during, and for 30 days following administration of the investigational drug product
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 |
|---|---|---|
| SB-509SB-509 60 mg, 3 treatments, and 5 months treatment period | Drug | SB-509 |
| SalineAlso: 30 ml saline, 3 treatments | Other | Placebo |
Primary outcome
To compare the effect of SB-509 versus placebo in subjects with moderately severe diabetic neuropathy (DN) on sural Nerve Conduction Velocity (NCV) at six-months
Time frame: 6 months
3 secondary outcomes
To evaluate the effect of SB-509 on Neuropathy Impairment Score - Lower Limb (NIS-LL), motor Nerve Conduction Velocity (NCV), Quantitative Sensory Testing (QST), Intraepidermal Nerve Fiber Density (IENFD), and Lower Extremity Neurological Sensory Exam
Time frame: 12 months
To evaluate the effect of SB-509 using a multi-endpoint analysis that includes NIS-LL, Sural NCV, and IENFD
Time frame: 12 months
To evaluate the safety of SB-509 in subjects with moderately severe diabetic neuropathy
Time frame: 12 months
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 23 May 2022.
- Related InfoLink provided by the sponsor.
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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.
Winson Tang, MD study director
Sangamo BioSciences, Inc
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SB-509 and Saline in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Sangamo Therapeutics at 31 sites 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 7 inclusion and 8 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 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To compare the effect of SB-509 versus placebo in subjects with moderately severe diabetic neuropathy (DN) on sural Nerve Conduction Velocity (NCV) at six-months (time frame: 6 months). 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 23 May 2022.