A Long-term Study for the Treatment of Painful Diabetic Neuropathy

A Superiority Study of LY248686 Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain - Extension Phase

The purpose of the study is to investigate safety and efficacy of duloxetine for patients with painful diabetic neuropathy at long-term use.

Inclusion Criteria:

• Outpatients who have completed the 13-week treatment in the preceding study (Protocol No. 0715N0831: NCT00552175).
• Patients who desire to receive continued treatment with LY248686 from the preceding study.
• Patients with latest glycosylated hemoglobin (HbA1c) ≤9.0% before Visit 7.
• Patients who can provide written consent in person.

Exclusion Criteria:

• Patients who concurrently have serious cardiovascular, hepatic, renal, respiratory, or blood disease, or symptomatic peripheral vascular disease, and thus are considered inappropriate to be included in the study.
• Pregnant patients or women who desire to become pregnant during the study period, and breast feeding patients.
• Other patients judged by the investigator/subinvestigator to be inappropriate as a subject in this study.