CompletedNCT00552175Updated Apr 13, 2010Results posted

A Study for the Treatment of Diabetic Peripheral Neuropathic Pain

A Phase 3 interventional study of Duloxetine hydrochloride - 40 mg and placebo in Diabetic Neuropathies, sponsored by Eli Lilly and Company. Completed at 25 sites in Japan. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2010-04-13.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 339
Allocation: Randomized
Ages: 20 Years to 79 Years
Sex: All

Study summary

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

Conditions studied

Diabetic Neuropathies

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In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 339 is above the median of 52 across 973 interventional studies indexed under Neuralgia.

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Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 79 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients with pain due to bilateral peripheral neuropathy induced by type 1 or 2 diabetes mellitus. The pain must have been present for at least 6 months and be evaluable in feet, legs, or hands.
Participants with hemoglobin A1c (HbA1c) less than or equal to 9.0 percent at Visit 1.
Participants in whom HbA1c had been measured 42-70 days before Visit 1 and subsequent HbA1c levels have been within +/- 1.0 percent of the level at Visit 1.
Participants with a mean of the 24-hour average pain severity scores (round off to a whole number) of 4 or higher, as calculated from the patient diary for 7 days immediately before Visit 2

Exclusion criteria

Exclusion Criteria:

Participants who have undergone renal transplant or who are currently on renal dialysis.
Participants who have a history requiring pharmacotherapy within the past year or current history of psychiatric disease, such as mania, bipolar disorder, depression, anxiety disorder, or eating disorder.
Participants with hypertension with poor control of blood pressure (systolic blood pressure greater than or equal to 180 millimeters of mercury (mmHg) or diastolic blood pressure greater than or equal to 110 mmHg
Participants with alanine transaminase (ALT) or aspartate transaminase (AST) greater than or equal to 100 Units per Liter (U/L) at Visit 1.
Participants unable to discontinue prohibited concomitant drugs or concomitant therapies after Visit 1.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 339 participants (actual)

Study arms

Experimental
Duloxetine 60
duloxetine 60 milligram (mg) taken orally every day
Drug: Duloxetine hydrochloride - 60 mg
Experimental
Duloxetine 40
Duloxetine 40 mg taken orally every day
Drug: Duloxetine hydrochloride - 40 mg
Placebo comparator
Placebo
placebo comparator taken orally every day
Drug: placebo

Interventions

DrugDuloxetine hydrochloride - 40 mg
duloxetine 40 mg taken orally every day
Also known as: LY248686, Cymbalta
Drugplacebo
placebo taken orally every day
DrugDuloxetine hydrochloride - 60 mg
duloxetine 60 mg taken orally every day
Also known as: LY248686, Cymbalta

What researchers measure

Primary outcomes

Change From Baseline at Week 12 in Average Pain Severity Rating Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)
Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time frame: Baseline, 12 weeks

Secondary outcomes

Change From Baseline at Week 12 in Average Pain Severity Rating Score Using Diaries
Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time frame: Baseline, 12 weeks
Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)
Pain severity for worst pain and night pain as measured by an 11-point numerical rating scale, collected by diaries and expressed as weekly means. A self-reported scale that measures the severity of pain based on the worst pain and night pain experienced over the past 24-hours. The worst pain and night pain severity scores each range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time frame: Baseline, 12 weeks
Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries
Pain severity for worst pain and night pain as measured by an 11-point numerical rating scale, collected by diaries and expressed as weekly means. A self-reported scale that measures the severity of pain based on the worst pain and night pain experienced over the past 24-hours. The worst pain and night pain severity scores each range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time frame: Baseline, Week 12
Patient Global Impression of Improvement Scale at Week 12 in Combined Duloxetine Arms (40 mg + 60 mg)
A scale that measures the patient'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).
Time frame: Week 12
Patient Global Impression of Improvement Scale at Week 12
A scale that measures the patient'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).
Time frame: Week 12
Change From Baseline in Brief Pain Inventory Severity Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)
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. Each question has a total range of scores from 0 to 10.
Time frame: Baseline, Week 12
Change From Baseline in Brief Pain Inventory Severity Scores at Week 12
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. Each question has a total range of scores from 0 to 10.
Time frame: Baseline, Week 12
Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)
The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each question has a total range of scores from 0 to 10.
Time frame: Baseline, Week 12
Change From Baseline in Brief Pain Inventory Interference Scores at Week 12
The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each question has a total range of scores from 0 to 10.
Time frame: Baseline, Week 12
Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)
A 21-item, patient-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 four-point scale for each item ranging from 0 to 3. Total score ranges from 0 (no depression) to 63 (severe depression).
Time frame: Baseline, Week 12
Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12
A 21-item, patient-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 four-point scale for each item ranging from 0 to 3. Total score ranges from 0 (no depression) to 63 (severe depression).
Time frame: Baseline, Week 12

Results

Posted Apr 13, 2010

Limitations and caveats

The protocol-specified primary analyses for this study were comparisons between combined duloxetine arms (40 mg + 60 mg) and placebo. The study was powered on combined duloxetine arms and statistical comparisons were not performed among single arms.

Participant flow

Participant flow — Overall Study
Milestone	Placebo	Duloxetine 40 mg	Duloxetine 60 mg
Started	167	86	86
Full analysis set population	167	85	86
Completed	150	73	72
Not completed	17	13	14
Withdrew: Lack of efficacy	2	0	1
Withdrew: Adverse event	9	9	10
Withdrew: Withdrawal by subject	2	2	1
Withdrew: Lost to follow-up	0	0	1
Withdrew: Entry criteria not met	1	1	0
Withdrew: Reason not specified	3	1	1

Outcome measures

PrimaryChange From Baseline at Week 12 in Average Pain Severity Rating Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)

Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).

Time frame:: Baseline, 12 weeks
Reported as:: Least squares mean · units on a scale

Change From Baseline at Week 12 in Average Pain Severity Rating Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)
units on a scale	Placebo	Duloxetine 40 mg and 60 mg Combined
Change From Baseline at Week 12 in Average Pain Severity Rating Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)	-1.61 ± 0.18	-2.47 ± 0.18

Statistical analysis

Placebo vs Duloxetine 40 mg and 60 mg Combined · Mixed Models Analysis · p = <0.0001 · Least squares mean difference: -0.87 · 95% CI -1.17 to -0.56Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.

SecondaryChange From Baseline at Week 12 in Average Pain Severity Rating Score Using Diaries

Time frame:: Baseline, 12 weeks
Reported as:: Least squares mean · units on a scale

Change From Baseline at Week 12 in Average Pain Severity Rating Score Using Diaries
units on a scale	Placebo	Duloxetine 40 mg	Duloxetine 60 mg
Change From Baseline at Week 12 in Average Pain Severity Rating Score Using Diaries	-1.61 ± 0.19	-2.41 ± 0.21	-2.53 ± 0.21

SecondaryChange From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)

Pain severity for worst pain and night pain as measured by an 11-point numerical rating scale, collected by diaries and expressed as weekly means. A self-reported scale that measures the severity of pain based on the worst pain and night pain experienced over the past 24-hours. The worst pain and night pain severity scores each range from 0 (no pain) to 10 (pain as severe as you can imagine).

Time frame:: Baseline, 12 weeks
Reported as:: Least squares mean · units on a scale

Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)
units on a scale	Placebo	Duloxetine 40 mg and 60 mg Combined
Worst Pain	-1.55 ± 0.19	-2.51 ± 0.19
Night Pain	-1.56 ± 0.19	-2.39 ± 0.19

Statistical analysis

Placebo vs Duloxetine 40 mg and 60 mg Combined · Mixed Models Analysis · p = <0.0001 (P-value for Worst Pain.) · Least squares mean difference: -0.96 · 95% CI -1.27 to -0.64Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 40 mg and 60 mg Combined · Mixed Models Analysis · p = <0.0001 (P-value for Night Pain.) · Least squares mean difference: -0.83 · 95% CI -1.15 to -0.51Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.

SecondaryChange From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries

Time frame:: Baseline, Week 12
Reported as:: Least squares mean · units on a scale

Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries
units on a scale	Placebo	Duloxetine 40 mg	Duloxetine 60 mg
Worst Pain	-1.55 ± 0.19	-2.42 ± 0.22	-2.59 ± 0.22
Night Pain	-1.56 ± 0.19	-2.33 ± 0.22	-2.45 ± 0.23

Statistical analysis

Placebo vs Duloxetine 40 mg · Mixed Models Analysis · Least squares mean difference: -0.87 · 95% CI -1.26 to -0.49Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 60 mg · Mixed Models Analysis · Least squares mean difference: -1.05 · 95% CI -1.43 to -0.66Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 40 mg · Mixed Models Analysis · Least squares mean difference: -0.78 · 95% CI -1.17 to -0.39Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 60 mg · Mixed Models Analysis · Least squares mean difference: -0.89 · 95% CI -1.28 to -0.5Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.

SecondaryPatient Global Impression of Improvement Scale at Week 12 in Combined Duloxetine Arms (40 mg + 60 mg)

A scale that measures the patient'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).

Time frame:: Week 12
Reported as:: Least squares mean · units on a scale

Patient Global Impression of Improvement Scale at Week 12 in Combined Duloxetine Arms (40 mg + 60 mg)
units on a scale	Placebo	Duloxetine 40 mg and 60 mg Combined
Patient Global Impression of Improvement Scale at Week 12 in Combined Duloxetine Arms (40 mg + 60 mg)	3.18 ± 0.12	2.53 ± 0.12

Statistical analysis

Placebo vs Duloxetine 40 mg and 60 mg Combined · Mixed Models Analysis · p = <0.0001 · Least squares mean difference: -0.65 · 95% CI -0.85 to -0.44Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.

SecondaryPatient Global Impression of Improvement Scale at Week 12

A scale that measures the patient'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).

Time frame:: Week 12
Reported as:: Least squares mean · units on a scale

Patient Global Impression of Improvement Scale at Week 12
units on a scale	Placebo	Duloxetine 40 mg	Duloxetine 60 mg
Patient Global Impression of Improvement Scale at Week 12	3.18 ± 0.12	2.53 ± 0.14	2.52 ± 0.14

Statistical analysis

Placebo vs Duloxetine 40 mg · Mixed Models Analysis · Least squares mean difference: -0.65 · 95% CI -0.9 to -0.39Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 60 mg · Mixed Models Analysis · Least squares mean difference: -0.65 · 95% CI -0.91 to -0.4Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.

SecondaryChange From Baseline in Brief Pain Inventory Severity Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)

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. Each question has a total range of scores from 0 to 10.

Time frame:: Baseline, Week 12
Reported as:: Least squares mean · units on a scale

Change From Baseline in Brief Pain Inventory Severity Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)
units on a scale	Placebo	Duloxetine 40 mg and 60 mg Combined
Worst Pain	-1.62 ± 0.21	-2.59 ± 0.21
Least Pain	-1.13 ± 0.21	-1.98 ± 0.21
Average Pain	-1.54 ± 0.2	-2.54 ± 0.2
Pain Right Now	-1.67 ± 0.22	-2.59 ± 0.22

Statistical analysis

Placebo vs Duloxetine 40 mg and 60 mg Combined · Mixed Models Analysis · p = <0.0001 (P-value for Worst Pain.) · Least squares mean difference: -0.98 · 95% CI -1.34 to -0.61Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 40 mg and 60 mg Combined · Mixed Models Analysis · p = <0.0001 (P-value for Least Pain.) · Least squares mean difference: -0.85 · 95% CI -1.21 to -0.48Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 40 mg and 60 mg Combined · Mixed Models Analysis · p = <0.0001 (P-value for Average Pain.) · Least squares mean difference: -1 · 95% CI -1.33 to -0.67Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 40 mg and 60 mg Combined · Mixed Models Analysis · p = <0.0001 (P-value for Pain Right Now.) · Least squares mean difference: -0.92 · 95% CI -1.29 to -0.54Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.

SecondaryChange From Baseline in Brief Pain Inventory Severity Scores at Week 12

Time frame:: Baseline, Week 12
Reported as:: Least squares mean · units on a scale

Change From Baseline in Brief Pain Inventory Severity Scores at Week 12
units on a scale	Placebo	Duloxetine 40 mg	Duloxetine 60 mg
Worst Pain	-1.62 ± 0.21	-2.51 ± 0.25	-2.68 ± 0.25
Least Pain	-1.13 ± 0.21	-1.92 ± 0.25	-2.04 ± 0.25
Average Pain	-1.55 ± 0.2	-2.53 ± 0.23	-2.56 ± 0.23
Pain Right Now	-1.67 ± 0.22	-2.55 ± 0.25	-2.62 ± 0.26

Statistical analysis

Placebo vs Duloxetine 40 mg · Mixed Models Analysis · Least squares mean difference: -0.89 · 95% CI -1.34 to -0.44Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 60 mg · Mixed Models Analysis · Least squares mean difference: -1.06 · 95% CI -1.51 to -0.62Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 40 mg · Mixed Models Analysis · Least squares mean difference: -0.78 · 95% CI -1.23 to -0.33Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 60 mg · Mixed Models Analysis · Least mean squares difference: -0.91 · 95% CI -1.36 to -0.46Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 40 mg · Mixed Models Analysis · Least squares mean difference: -0.98 · 95% CI -1.39 to -0.58Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 60 mg · Mixed Models Analysis · Least squares mean difference: -1.01 · 95% CI -1.41 to -0.61Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 40 mg · Mixed Models Analysis · Least squares mean difference: -0.88 · 95% CI -1.35 to -0.41Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 60 mg · Mixed Models Analysis · Least squares mean difference: -0.95 · 95% CI -1.41 to -0.48Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.

SecondaryChange From Baseline in Brief Pain Inventory Interference Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)

The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each question has a total range of scores from 0 to 10.

Time frame:: Baseline, Week 12
Reported as:: Least squares mean · units on a scale

Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)
units on a scale	Placebo	Duloxetine 40 mg and 60 mg Combined
General Activity	-1.88 ± 0.24	-2.29 ± 0.24
Mood	-1.91 ± 0.24	-2.28 ± 0.24
Walking Ability	-1.82 ± 0.23	-2.31 ± 0.23
Normal Work	-1.49 ± 0.23	-1.86 ± 0.23
Relation to People	-0.77 ± 0.23	-1.32 ± 0.23
Sleep	-1.69 ± 0.24	-2.15 ± 0.24
Enjoyment of Life	-1.59 ± 0.23	-2.15 ± 0.23
Average of Interference Scores	-1.56 ± 0.2	-2.04 ± 0.2

Statistical analysis

Placebo vs Duloxetine 40 mg and 60 mg Combined · Mixed Models Analysis · p = 0.0676 (P-value for General Activity.) · Least squares mean difference: -0.41 · 95% CI -0.85 to 0.03Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 40 mg and 60 mg Combined · Mixed Models Analysis · p = 0.0933 (P-value for Mood.) · Least squares mean difference: -0.37 · 95% CI -0.8 to 0.06Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 40 mg and 60 mg Combined · Mixed Models Analysis · p = 0.0228 (P-value for Walking Ability.) · Least squares mean difference: -0.49 · 95% CI -0.91 to -0.07Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 40 mg and 60 mg Combined · Mixed Models Analysis · p = 0.0783 (P-value for Normal Work.) · Least squares mean difference: -0.38 · 95% CI -0.8 to 0.04Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 40 mg and 60 mg Combined · Mixed Models Analysis · p = 0.0076 (P-value for Relation to People.) · Least squares mean difference: -0.55 · 95% CI -0.96 to -0.15Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 40 mg and 60 mg Combined · Mixed Models Analysis · p = 0.0378 (P-value for Sleep.) · Least squares mean difference: -0.46 · 95% CI -0.9 to -0.03Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 40 mg and 60 mg Combined · Mixed Models Analysis · p = 0.0089 (P-value for Enjoyment of Life.) · Least squares mean difference: -0.56 · 95% CI -0.98 to -0.14Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 40 mg and 60 mg Combined · Mixed Models Analysis · p = 0.0095 (P-value for Average of Interference Scores) · Least squares mean difference: -0.48 · 95% CI -0.85 to -0.12Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.

SecondaryChange From Baseline in Brief Pain Inventory Interference Scores at Week 12

Time frame:: Baseline, Week 12
Reported as:: Least squares mean · units on a scale

Change From Baseline in Brief Pain Inventory Interference Scores at Week 12
units on a scale	Placebo	Duloxetine 40 mg	Duloxetine 60 mg
General Activity	-1.88 ± 0.24	-2.48 ± 0.29	-2.1 ± 0.29
Mood	-1.91 ± 0.24	-2.18 ± 0.29	-2.39 ± 0.29
Walking Ability	-1.82 ± 0.23	-2.32 ± 0.28	-2.31 ± 0.28
Normal Work	-1.49 ± 0.23	-1.84 ± 0.28	-1.9 ± 0.28
Relation to People	-0.77 ± 0.23	-1.16 ± 0.27	-1.49 ± 0.27
Sleep	-1.69 ± 0.24	-2.26 ± 0.29	-2.05 ± 0.29
Enjoyment of Life	-1.59 ± 0.23	-1.96 ± 0.28	-2.35 ± 0.28
Average of Interference Scores	-1.56 ± 0.2	-2 ± 0.24	-2.08 ± 0.24

Statistical analysis

Placebo vs Duloxetine 40 mg · Mixed Models Analysis · Least squares mean difference: -0.6 · 95% CI -1.14 to -0.06Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 60 mg · Mixed Models Analysis · Least squares mean difference: -0.23 · 95% CI -0.77 to 0.32Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 40 mg · Mixed Models Analysis · Least squares mean difference: -0.27 · 95% CI -0.8 to 0.27Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 60 mg · Mixed Models Analysis · Least squares mean difference: -0.48 · 95% CI -1.01 to 0.05Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 40 mg · Mixed Models Analysis · Least squares mean difference: -0.5 · 95% CI -1.02 to 0.02Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 60 mg · Mixed Models Analysis · Least squares mean difference: -0.49 · 95% CI -1.01 to 0.03Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 40 mg · Mixed Models Analysis · Least squares mean difference: -0.35 · 95% CI -0.86 to 0.16Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 60 mg · Mixed Models Analysis · Least squares mean difference: -0.41 · 95% CI -0.92 to 0.11Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 40 mg · Mixed Models Analysis · Least squares mean difference: -0.39 · 95% CI -0.89 to 0.11Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 60 mg · Mixed Models Analysis · Least squares mean difference: -0.71 · 95% CI -1.21 to -0.22Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 40 mg · Mixed Models Analysis · Least squares mean difference: -0.57 · 95% CI -1.11 to -0.03Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 60 mg · Mixed Models Analysis · Least squares mean difference: -0.36 · 95% CI -0.9 to 0.18Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 40 mg · Mixed Models Analysis · Least squares mean difference: -0.37 · 95% CI -0.88 to 0.15Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 60 mg · Mixed Models Analysis · Least squares mean difference: -0.76 · 95% CI -1.27 to -0.24Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 40 mg · Mixed Models Analysis · Least squares mean difference: -0.45 · 95% CI -0.9 to 0Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 60 mg · Mixed Models Analysis · Least squares mean difference: -0.52 · 95% CI -0.97 to -0.07Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.

SecondaryChange From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)

A 21-item, patient-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 four-point scale for each item ranging from 0 to 3. Total score ranges from 0 (no depression) to 63 (severe depression).

Time frame:: Baseline, Week 12
Reported as:: Least squares mean · units on a scale

Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)
units on a scale	Placebo	Duloxetine 40 mg and 60 mg Combined
Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)	-3.27 ± 0.64	-3.37 ± 0.64

Statistical analysis

Placebo vs Duloxetine 40 mg and 60 mg Combined · Mixed Models Analysis · p = 0.8517 · Least squares mean difference: -0.11 · 95% CI -1.22 to 1.01Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.

SecondaryChange From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12

Time frame:: Baseline, Week 12
Reported as:: Least squares mean · units on a scale

Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12
units on a scale	Placebo	Duloxetine 40 mg	Duloxetine 60 mg
Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12	-3.28 ± 0.65	-2.94 ± 0.76	-3.83 ± 0.77

Statistical analysis

Placebo vs Duloxetine 40 mg · Mixed Models Analysis · Least squares mean difference: 0.34 · 95% CI -1.03 to 1.71Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.
Placebo vs Duloxetine 60 mg · Mixed Models Analysis · Least squares mean difference: -0.55 · 95% CI -1.92 to 0.81Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.

Adverse events

Non-serious events are listed at a 4% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	—	6/167 (3.6%)	121/167 (72.5%)
Duloxetine 40 mg	—	3/85 (3.5%)	71/85 (83.5%)
Duloxetine 60 mg	—	2/86 (2.3%)	73/86 (84.9%)

Most frequent serious events

Showing 10 of 25

Most frequent serious events
Event	Placebo	Duloxetine 40 mg	Duloxetine 60 mg
Alcohol poisoningInjury, poisoning and procedural complications	0/167	1/85	0/86
ContusionInjury, poisoning and procedural complications	0/167	1/85	0/86
Ulna fractureInjury, poisoning and procedural complications	0/167	1/85	0/86
HypoglycaemiaMetabolism and nutrition disorders	0/167	1/85	0/86
EpiglottitisInfections and infestations	0/167	0/85	1/86
RadiculopathyNervous system disorders	0/167	0/85	1/86
Self injurious behaviourPsychiatric disorders	0/167	0/85	1/86
Hepatic function abnormalHepatobiliary disorders	1/167	0/85	0/86
Arthritis bacterialInfections and infestations	1/167	0/85	0/86
OsteomyelitisInfections and infestations	1/167	0/85	0/86

Most frequent other events

Showing 10 of 24

Most frequent other events
Event	Placebo	Duloxetine 40 mg	Duloxetine 60 mg
SomnolenceNervous system disorders	14/167	16/85	21/86
NauseaGastrointestinal disorders	3/167	10/85	14/86
NasopharyngitisInfections and infestations	24/167	10/85	14/86
Aspartate aminotransferase increasedInvestigations	6/167	5/85	8/86
DiarrhoeaGastrointestinal disorders	6/167	4/85	7/86
ConstipationGastrointestinal disorders	9/167	6/85	5/86
Blood creatine phosphokinase increasedInvestigations	6/167	6/85	0/86
DizzinessNervous system disorders	2/167	6/85	4/86
MalaiseGeneral disorders	3/167	3/85	6/86
Alanine aminotransferase increasedInvestigations	6/167	5/85	5/86

Baseline characteristics

Age Continuous
Age Continuous(years)	Placebo	Duloxetine 40 mg	Duloxetine 60 mg	Total
Mean	60.8 ± 9.2	62.1 ± 9.3	59.7 ± 12.1	60.8 ± 10

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	Duloxetine 40 mg	Duloxetine 60 mg	Total
Female	38	20	24	82
Male	129	65	62	256

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Placebo	Duloxetine 40 mg	Duloxetine 60 mg	Total
Japanese	167	85	86	338

Region of Enrollment
Region of Enrollment(participants)	Placebo	Duloxetine 40 mg	Duloxetine 60 mg	Total
Japan	167	85	86	338

Duration of Diabetes
Duration of Diabetes(participants)	Placebo	Duloxetine 40 mg	Duloxetine 60 mg	Total
<5 years	33	20	16	69
5 - 10 years	32	18	14	64
>= 10 years	97	47	56	200
Unknown	5	0	0	5

Type of Diabetes
Type of Diabetes(participants)	Placebo	Duloxetine 40 mg	Duloxetine 60 mg	Total
Type I	8	5	4	17
Type II	159	80	82	321

Beck Depression Inventory-II (BDI-II)
Beck Depression Inventory-II (BDI-II)(units on a scale)	Placebo	Duloxetine 40 mg	Duloxetine 60 mg	Total
Mean	8.8 ± 6.8	9.4 ± 8.8	9.4 ± 7.2	9.1 ± 7.4

Body Mass Index (BMI)
Body Mass Index (BMI)(kilograms/square meters (kg/m^2))	Placebo	Duloxetine 40 mg	Duloxetine 60 mg	Total
Mean	23.90 ± 3.70	23.27 ± 3.67	24.20 ± 3.50	23.82 ± 3.65

6 further baseline measures are reported on the registry.

Study locations

25 sites

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Aichi, Japan
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Aomori, Japan
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Chiba, Japan
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Fukui, Japan
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Fukuoka, Japan
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Fukushima, Japan
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Gunma, Japan
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Hiroshima, Japan
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Hokkaido, Japan
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Hyogo, Japan
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Ibaraki, Japan
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Kagoshima, Japan
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Kanagawa, Japan
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Kyoto, Japan
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Miyagi, Japan
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Niigata, Japan
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Oita, Japan
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Okayama, Japan
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Osaka, Japan
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Saitama, Japan
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Shizuoka, Japan
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Tochigi, Japan
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Tokushima, Japan
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Tokyo, Japan
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Toyama, Japan

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 13, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00552175
Lead sponsor: Eli Lilly and Company
Collaborators: Shionogi
First posted: Nov 1, 2007
Start date: Nov 2007
Primary completion: Mar 2009
Completion: Mar 2009
Results posted: Apr 13, 2010
Last update: Apr 13, 2010

Study contacts

Call 1-877-CTLILLY(1-877-285-4559) OR 1-317-615-4559 Mon-Fri 9 AM-5 PM Eastern time (UTC/GMT-5 hours,EST)

study director · Eli Lilly and Company

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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