NCT01475786

Safety and Efficacy Study for the Treatment of Painful Diabetic Neuropathy

A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Engensis (VM202) in Subjects With Painful Diabetic Peripheral Neuropathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Helixmith Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if Engensis (VM202) is safe and effective in treating painful diabetic neuropathy.

Detailed description

Peripheral neuropathy is a serious complication of diabetes. This form of neuropathy carries a high risk of pain, trophic changes and autonomic dysfunction. There is currently no effective treatment for diabetic neuropathy, and good glycemic control is the only way to minimize the risk of occurrence. Clearly, it would be desirable to prevent, impede, or reverse the disrupting and often life-threatening manifestations of peripheral neuropathy by stimulating growth or regeneration of peripheral nerve axons.

Conditions

• Painful Diabetic Neuropathies

Interventions

Type	Name	Description
BIOLOGICAL	Low Dose: 16 mg Engensis (VM202)	Subjects in the Low Dose Group (8mg VM202 / leg) will receive the following intramuscular injections in each calf: Day 0 - 32 injections / calf: • 16 injections of 0.5mL of VM202 / calf - (4 mg of VM202 / calf) Day 14 - 32 injections / calf: • 16 injections of 0.5mL of VM202 / calf - (4 mg of VM202 / calf)
BIOLOGICAL	High Dose: 32 mg Engensis (VM202)	Subjects in the High Dose Group (16 mg VM202 / leg) will receive the following intramuscular injections in each calf: Day 0 • 32 injections of 0.5mL of VM202 / calf (8 mg of VM202 / calf) Day 14 • 32 injections of 0.5mL of VM202 / calf (8 mg of VM202 / calf)
OTHER	Control- Placebo (normal saline)	subjects will receive thirty-two (32) 0.5 mL injections of normal saline on Day 0 and Day 14.

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-03-12
• Completion: 2014-06-01
• First posted: 2011-11-21
• Last updated: 2025-10-06
• Results posted: 2023-07-03

Locations

17 sites across 2 countries: United States, South Korea