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

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

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

Conditions
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Diabetic Neuropathies

Intervention / Treatment
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* Drug: Duloxetine hydrochloride
* Drug: Duloxetine hydrochloride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duloxetine 40 mg<br>Duloxetine 40 milligrams (mg) once daily (QD), orally (PO), 1 year | Drug: Duloxetine hydrochloride<br>* Duloxetine 40 mg QD, PO, 1 year<br>* Other names: Cymbalta;|
| Experimental: Duloxetine 60 mg<br>Duloxetine 60 mg QD, PO, 1 year | Drug: Duloxetine hydrochloride<br>* Duloxetine 60 mg QD, PO, 1 year<br>* Other names: Cymbalta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced an Adverse Event (AE) | See the Reported Adverse Events section for details. | baseline through 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Impression of Improvement (PGI-I) Scale at One Year Endpoint. | A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). | 1 year | 
| Change From Baseline to One Year Endpoint for Patient Global Impression of Improvement (PGI-I) Scale | A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). | baseline, 1 year | 
| Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint | A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. | 1 year | 
| Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores | A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. | baseline, 1 year | 
| Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint | Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes). | 1 year | 
| Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores | Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes). | baseline, 1 year | 
| Beck Depression Inventory-II (BDI-II) Total Score at One Year Endpoint | A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. | 1 year | 
| Change From Baseline to One Year Endpoint in Beck Depression Inventory-II (BDI-II) Total Score | A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. | baseline, 1 year |