Trial intelligence / Profile preview

SB-509 in Moderately Severe Diabetic Neuropathy

NCT01079325Phase 2

Key facts

Status: Completed
Start: Nov 2009
Primary completion: May 2015
Countries: 1
Sponsor: Sangamo Therapeutics
Modality: Gene Silencing, Plasmid DNA, Zinc Finger Nucleases

Drugs: SB-509
Conditions: diabetic polyneuropathy (DPN)

Overview

Phase 2, randomised, double-blind trial in diabetic polyneuropathy (DPN) comparing SB-509 with Placebo (2 arms). Primary endpoint: Sural Nerve Conduction Velocity at 6 months. Started Nov 2009; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

SB-509
SB-509 60 mg, 3 treatments
Placebo
Saline, 3 treatments

Who it enrols

Adults with Type 1 or 2 Diabetes and moderate to severe diabetic sensory-motor polyneuropathy, HbA1c <= 10%, BMI <= 38, and no history of significant heart disease or malignancy.

Endpoints

Primary

Sural Nerve Conduction Velocity6 months

Secondary

Neuropathy Impairment Score - Lower Limb12 months
Motor Nerve Conduction Velocity12 months
Quantitative Sensory Testing12 months
Intraepidermal Nerve Fiber Density12 months
Lower Extremity Neurological Sensory Exam12 months
Safety of SB-50912 months

Results

Not all primary endpoints met

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