104
Participants
Start Date
August 31, 2012
Primary Completion Date
March 12, 2014
Study Completion Date
June 30, 2014
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)"
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)"
Control- Placebo (normal saline)
subjects will receive thirty-two (32) 0.5 mL injections of normal saline on Day 0 and Day 14.
Mount Sinai Medical Center, New York
The Neurosciences Institute Albany Medical College, Albany
East Virginia Medical School Strelitz Diabetes Center, Norfolk
Compass Research, Orlando
Palm Beach Neurological Center, Palm Beach Gardens
Northwestern University, Chicago
University of Oklahoma Harold Hamm Diabetes Center, Oklahoma City
Houston Neurocare, Houston
The Methodist Hospital, Houston
University of Utah, Salt Lake City
Diablo Clinical Research, Walnut Creek
Rainier Clinical Research, Seattle
Beth Israel Deaconess, Boston
Seoul National University Bundang Hospital, Seongnam
Yonsei University College of Medicine Severance Hospital, Seoul
Sejong General Hospital, Bucheon-si
The Catholic University of Korea Youido St. Mary's Hospital, Seoul
Helixmith Co., Ltd.
INDUSTRY