Diabetes Mellitus, Diabetic Neuropathies
Conditions
Brief summary
The purpose of this protocol is to determine if an investigational drug is effective in treating nerve malfunction in diabetes.
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have type I or type II Diabetes Mellitus. * Have been clinically diagnosed with neuropathy. * Have an HbA1C less than or equal to 12%. Patients with HbA1C greater than 9% must be on insulin therapy. * Must be 18 years or older. * Be able to visit the doctor's office approximately 3 times over a maximum of a 6-week period to determine if you can continue in the study.
Exclusion criteria
* History of significant liver problems. * Have poor kidney function. * Drink an excess of alcohol or abuse drugs. * Have recently participated in or are currently participating in a Medical study in which you receive an experimental drug. * Are a woman and are pregnant or breastfeeding, intending to become pregnant within the next 2 years, or are a woman not using an effective method of birth control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the progression of DPN measured by composite score | — |
Secondary
| Measure | Time frame |
|---|---|
| Vibration sensation;Electrophysiology of tibial, peroneal and sural nerves;Neurological signs;Neuropathic symptoms;Clinical global impression of change;Health outcome measures | — |
Countries
Australia, Belgium, Canada, Croatia, Denmark, Estonia, Finland, Germany, Hungary, India, Lithuania, Netherlands, Spain, United Kingdom, United States
Outcome results
None listed