A Study for the Treatment of Painful Diabetic Neuropathy

Duloxetine Versus Placebo in the Treatment of Patients With Painful Diabetic Neuropathy

The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.

The protocol will assess the efficacy and safety of duloxetine. It will also look at how duloxetine affects quality of life.

Inclusion Criteria:

• Male or female outpatients at least 18 years of age.
• Patients with pain due to diabetic neuropathy in both legs.
• Females must not be pregnant or plan to become pregnant during the study.
• Stable Glycemic control.
• Average mean pain severity score of at least 4.0 as assessed by completion of a daily diary.

Exclusion Criteria:

• You are related to or work for the physician conducting the study or are employed by Eli Lilly and Company.
• You have a severe or serious medical condition that causes you to be hospitalized often; or you have had a kidney transplant or are on current dialysis.
• You have participated in a study for an investigational drug within the last 30 days.
• You have a history of major depressive disorder, generalized anxiety disorder, or alcohol or eating disorders.
• You have a past medical history or diagnosis of mania, bipolar disorder, or psychosis.