This trial is being carried out to examine the effectiveness of LY3016859 for diabetic neuropathic pain (DNP; pain caused by damage to the nerves). The main outcome to be measured is a change in pain intensity. This study is being carried out in Puerto Rico and the United States.
Uncontrolled diabetes can lead to damage in the nerves, particularly those in the feet. This leads to burning or shooting pain. In time, if untreated, this can lead to a loss of feeling in the affected area. Therefore patients are more likely to injure themselves and not get treated. Finally, this can lead to infections and even the need to amputate (remove) the affected limp.
LY3016859 is an experimental treatment. It has shown promise in treating nerve pain. This trial is being carried out to assess the safety and effectiveness of LY3016859 for the treatment of DNP. The main outcome to be measured is the change in average pain intensity over a time-frame of 8 weeks.
Who are they looking for?
This trial is looking to recruit 125 patients with DNP. To be included in this trial patients must have a history of daily pain for at least 12-weeks and have a current diagnosis of type 1 or type 2 diabetes mellitus. Participants must agree to stop all pain medication except those approved by the study protocol and have a stable blood glucose level.
Patients will be excluded is they have significant heart disease, have had a procedure in the last 6-months to produce a permanent sensory loss in the target area of interest, have any planned surgery, and have had cancer within 2 years before starting this trial.
How will it work
There will be two groups in this trial. One group will receive the drug LY3016859. The other group will receive a placebo drug. The drugs will be administered by an injection into the vein.
This trial will be carried out over 8-weeks. A reduction in average pain intensity and the patients' impression of their pain will be measured over the 8-week period.