Diabetes Mellitus, Insulin-Dependent, Diabetes Mellitus, Non-Insulin-Dependent, 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 clinically diagnosed positive sensory symptoms such as numbness, lancinating pain, burning pain, aching pain, allodynia and prickling sensation that have been present not greater than 5 years but stable for 6 months. * Has a 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 or currently participating in a Medical study in which you receive an experimental drug. * Are a woman and are pregnant or breastfeeding, intend to become pregnant within the next 2 years or a woman not using effective birth control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in neuropathic symptoms | — |
Secondary
| Measure | Time frame |
|---|---|
| Vibration sensation;Neurological signs;Electrophysiology of peroneal, tibial and sural nerves;Relief of symptoms as measured by VAS;Composite scores of nerve function;Clinical global impression of change | — |
Countries
Australia, Belgium, Denmark, Estonia, Germany, Hungary, Israel, Spain, United States
Outcome results
None listed