CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 104 enrolled
Drug / intervention
Low Dose: 16 mg Engensis (VM202) +2 morebiological
Likely dose
Low Dose: 16 mg Engensis (VM202)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01475786
NCT01475786Phase 2Completed
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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

Helixmith Co., Ltd.·interventional·Posted Nov 21, 2011·Updated Oct 6, 2025

In Brief

A Phase 2 clinical trial evaluating Low Dose: 16 mg Engensis (VM202), High Dose: 32 mg Engensis (VM202), and 1 other intervention for Painful Diabetic Neuropathies. Completed, enrolled 104 participants across 17 sites in 2 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPainful Diabetic Neuropathies
CountriesSouth Korea, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 21, 2011
Enrollment StartAug 1, 2012
Primary CompletionMar 12, 2014
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.6 years ago

Interventions

Low Dose: 16 mg Engensis (VM202)biological

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)

High Dose: 32 mg Engensis (VM202)biological

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)

Control- Placebo (normal saline)other

subjects will receive thirty-two (32) 0.5 mL injections of normal saline on Day 0 and Day 14.