Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Phase 2b Repeat Dosing Clinical Trial of SB-509 in Subjects With Moderately Severe Diabetic Neuropathy
Verified date | May 2022 |
Source | Sangamo Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to evaluate the clinical effects of the investigational drug, SB-509, in subjects with diabetic neuropathy.
Status | Completed |
Enrollment | 170 |
Est. completion date | April 2016 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Key Inclusion Criteria: - 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 Key Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sangamo Therapeutics | Juvenile Diabetes Research Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 6 months | ||
Secondary | 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 | 12 months | ||
Secondary | To evaluate the effect of SB-509 using a multi-endpoint analysis that includes NIS-LL, Sural NCV, and IENFD | 12 months | ||
Secondary | To evaluate the safety of SB-509 in subjects with moderately severe diabetic neuropathy | 12 months |
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