Trial Outcomes & Findings for Duloxetine in Patients With Diabetic in Peripheral Neuropathic Pain With or Without Co-morbid Major Depressive Disorder (NCT NCT00844194)

NCT ID: NCT00844194

Last Updated: 2014-05-15

Results Overview

The change from baseline reflects the week 12 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 108 participants
• Primary outcome timeframe: Baseline and Week 12
• Results posted on: 2014-05-15

Participant Flow

Participant milestones

Measure	Without Major Depressive Disorder (MDD-) Patients with diabetic polyneuropathy and no depression	With Major Depressive Disorder (MDD+) Patients with diabetic polyneuropathy and depression
Overall Study STARTED	78	30
Overall Study COMPLETED	53	22
Overall Study NOT COMPLETED	25	8

Reasons for withdrawal

Measure	Without Major Depressive Disorder (MDD-) Patients with diabetic polyneuropathy and no depression	With Major Depressive Disorder (MDD+) Patients with diabetic polyneuropathy and depression
Overall Study Adverse Event	17	5
Overall Study Protocol Violation	1	1
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	2	1
Overall Study Lack of Efficacy	3	0
Overall Study Other reason (not specified)	1	0

Baseline Characteristics

Duloxetine in Patients With Diabetic in Peripheral Neuropathic Pain With or Without Co-morbid Major Depressive Disorder

Baseline characteristics by cohort

Measure	Without Major Depressive Disorder (MDD-) n=78 Participants Patients with diabetic polyneuropathy and no depression	With Major Depressive Disorder (MDD+) n=30 Participants Patients with diabetic polyneuropathy and depression	Total n=108 Participants Total of all reporting groups
Age, Continuous	67.5 Years STANDARD_DEVIATION 10.2 • n=5 Participants	66.6 Years STANDARD_DEVIATION 9.8 • n=7 Participants	67.3 Years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	15 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	15 Participants n=7 Participants	57 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 12 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=65 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12	-2.2 Scores on a scale Standard Deviation 2.2	-1.4 Scores on a scale Standard Deviation 1.91	—	—

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 12 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=16 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=40 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder n=15 Participants MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder n=6 Participants MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12	-2.2 Scores on a scale Standard Deviation 2.0	-1.7 Scores on a scale Standard Deviation 1.65	-0.9 Scores on a scale Standard Deviation 2.5	-2.6 Scores on a scale Standard Deviation 3.31

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 6 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=57 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 6	-2.0 Scores on a scale Standard Deviation 1.96	-1.2 Scores on a scale Standard Deviation 1.88	—	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=28 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=66 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in BPI Worst Pain During Treatment From Baseline to Week 2	-1.9 Scores on a scale Standard Deviation 2.19	-2.2 Scores on a scale Standard Deviation 2.27	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=57 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Worst Pain (BPI) From Baseline to Week 6	-3.3 Scores on a scale Standard Deviation 2.56	-2.6 Scores on a scale Standard Deviation 2.36	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=64 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Worst Pain (BPI) From Baseline to Week 12	-3.2 Scores on a scale Standard Deviation 3.41	-2.8 Scores on a scale Standard Deviation 2.55	—	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=28 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=66 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Least Pain (BPI) From Baseline to Week 2	-0.2 Scores on a scale Standard Deviation 1.7	-1.1 Scores on a scale Standard Deviation 2.35	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=57 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Least Pain During Treatment (BPI) From Baseline to Week 6	-1.3 Scores on a scale Standard Deviation 2.1	-1.7 Scores on a scale Standard Deviation 1.92	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=65 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Least Pain (BPI) From Baseline to Week 12	-1.1 Scores on a scale Standard Deviation 2.07	-1.5 Scores on a scale Standard Deviation 2.13	—	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=28 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=66 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Average Pain (BPI) From Baseline to Week 2	-1.1 Scores on a scale Standard Deviation 1.63	-1.6 Scores on a scale Standard Deviation 1.87	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=57 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Average Pain During Treatment (BPI) From Baseline to Week 6	-2.6 Scores on a scale Standard Deviation 2.0	-2.6 Scores on a scale Standard Deviation 1.92	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=65 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Average Pain (BPI) From Baseline to Week 12	-2.2 Scores on a scale Standard Deviation 2.07	-2.4 Scores on a scale Standard Deviation 1.88	—	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=30 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=71 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Number of Patients With a Reduction in BPI Average Pain at Week 2 >=30%	9 Participants	29 Participants	—	—
Number of Patients With a Reduction in BPI Average Pain at Week 2 >=50%	3 Participants	19 Participants	—	—
Number of Patients With a Reduction in BPI Average Pain at Week 2 Missing	2 Participants	5 Participants	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=30 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=71 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Number of Patients With a Reduction in BPI Average Pain at Week 6 >=30%	17 Participants	42 Participants	—	—
Number of Patients With a Reduction in BPI Average Pain at Week 6 >=50%	12 Participants	30 Participants	—	—
Number of Patients With a Reduction in BPI Average Pain at Week 6 Missing	6 Participants	14 Participants	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=30 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=71 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Number of Patients With a Reduction in BPI Average Pain at Week 12 >=30%	17 Participants	42 Participants	—	—
Number of Patients With a Reduction in BPI Average Pain at Week 12 >=50%	11 Participants	30 Participants	—	—
Number of Patients With a Reduction in BPI Average Pain at Week 12 Missing	4 Participants	6 Participants	—	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the pain at week 2 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=28 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=66 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Pain During Treatment (BPI) From Baseline to Week 2	-1.0 Scores on a scale Standard Deviation 2.06	-1.4 Scores on a scale Standard Deviation 2.34	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the pain at week 6 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=57 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Pain (BPI) From Baseline to Week 6	-1.7 Scores on a scale Standard Deviation 3.01	-2.0 Scores on a scale Standard Deviation 2.27	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the pain at week 12 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=65 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Pain During Treatment (BPI) From Baseline to Week 12	-1.5 Scores on a scale Standard Deviation 2.21	-1.7 Scores on a scale Standard Deviation 2.6	—	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 2 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=25 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=62 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 2	18.0 scores on a scale Standard Deviation 35.0	21.5 scores on a scale Standard Deviation 33.87	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 6 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=23 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=51 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 6	31.7 scores on a scale Standard Deviation 45.49	23.5 scores on a scale Standard Deviation 37.3	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 12 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=54 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 12	22.9 scores on a scale Standard Deviation 33.55	30.2 scores on a scale Standard Deviation 35.85	—	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=28 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=67 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Interference of Pain With General Activity (BPI) From Baseline to Week 2	-1.1 Scores on a scale Standard Deviation 2.02	-1.6 Scores on a scale Standard Deviation 2.5	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=57 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Interference of Pain With General Activity (BPI) From Baseline to Week 6	-2.5 Scores on a scale Standard Deviation 3.16	-1.8 Scores on a scale Standard Deviation 2.89	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=65 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Interference of Pain With General Activity (BPI) From Baseline to Week 12	-2.7 Scores on a scale Standard Deviation 2.76	-2.4 Scores on a scale Standard Deviation 2.53	—	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=28 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=66 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Interference of Pain With Mood (BPI) From Baseline to Week 2	-1.5 Scores on a scale Standard Deviation 1.73	-1.1 Scores on a scale Standard Deviation 2.3	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=57 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Interference of Pain With Mood (BPI) From Baseline to Week 6	-3.1 Scores on a scale Standard Deviation 3.08	-1.4 Scores on a scale Standard Deviation 2.4	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=65 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Interference of Pain With Mood (BPI) From Baseline to Week 12	-3.0 Scores on a scale Standard Deviation 3.28	-1.2 Scores on a scale Standard Deviation 2.68	—	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=28 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=66 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 2	-1.0 Scores on a scale Standard Deviation 2.19	-0.9 Scores on a scale Standard Deviation 2.03	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=56 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 6	-2.1 Scores on a scale Standard Deviation 3.26	-1.3 Scores on a scale Standard Deviation 2.55	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=65 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 12	-2.4 Scores on a scale Standard Deviation 3.11	-1.9 Scores on a scale Standard Deviation 2.86	—	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=28 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=65 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 2	-0.1 Scores on a scale Standard Deviation 2.34	-0.9 Scores on a scale Standard Deviation 1.76	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=57 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 6	-1.3 Scores on a scale Standard Deviation 2.92	-1.1 Scores on a scale Standard Deviation 2.47	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=64 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 12	-1.8 Scores on a scale Standard Deviation 2.67	-1.4 Scores on a scale Standard Deviation 1.89	—	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=28 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=67 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 2	-0.1 Scores on a scale Standard Deviation 2.80	-0.5 Scores on a scale Standard Deviation 2.68	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=57 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 6	-1.7 Scores on a scale Standard Deviation 2.60	-0.6 Scores on a scale Standard Deviation 2.64	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=64 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 12	-1.7 Scores on a scale Standard Deviation 2.71	-0.4 Scores on a scale Standard Deviation 2.42	—	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=28 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=66 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Interference of Pain With Sleep (BPI) From Baseline to Week 2	-1.0 Scores on a scale Standard Deviation 2.46	-0.8 Scores on a scale Standard Deviation 3.21	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=57 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Interference of Pain With Sleep (BPI) From Baseline to Week 6	-1.5 Scores on a scale Standard Deviation 3.44	-1.1 Scores on a scale Standard Deviation 3.50	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=65 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Interference of Pain With Sleep (BPI) From Baseline to Week 12	-1.9 Scores on a scale Standard Deviation 3.05	-1.5 Scores on a scale Standard Deviation 2.53	—	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=28 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=67 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 2	-0.6 Scores on a scale Standard Deviation 1.97	-0.7 Scores on a scale Standard Deviation 2.06	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=57 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 6	-2.2 Scores on a scale Standard Deviation 2.90	-1.2 Scores on a scale Standard Deviation 2.52	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=65 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 12	-2.1 Scores on a scale Standard Deviation 2.30	-0.9 Scores on a scale Standard Deviation 2.93	—	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=28 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=67 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Patient Global Impression - Improvement (PGI-I) at Week 2	3.2 Scores on a scale Standard Deviation 0.82	3.0 Scores on a scale Standard Deviation 1.01	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=23 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=57 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Patient Global Impression - Improvement (PGI-I) at Week 6	2.5 Scores on a scale Standard Deviation 1.04	2.5 Scores on a scale Standard Deviation 0.87	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=64 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Patient Global Impression - Improvement (PGI-I) at Week 12	2.7 Scores on a scale Standard Deviation 1.29	2.5 Scores on a scale Standard Deviation 1.35	—	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 2 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=63 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 2	-3.1 Scores on a scale Standard Deviation 5.79	-0.9 Scores on a scale Standard Deviation 3.61	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 6 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=23 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=50 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 6	-7.3 Scores on a scale Standard Deviation 7.05	-1.8 Scores on a scale Standard Deviation 5.93	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 12 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=58 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 12	-7.8 Scores on a scale Standard Deviation 7.25	-1.6 Scores on a scale Standard Deviation 6.02	—	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 2 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=28 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=67 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Total Score From Baseline to Week 2	-1.2 Scores on a scale Standard Deviation 2.94	-0.7 Scores on a scale Standard Deviation 2.23	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 6 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=56 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in HADS Anxiety Total Score From Baseline to Week 6	-2.2 Scores on a scale Standard Deviation 3.03	-0.8 Scores on a scale Standard Deviation 2.98	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 12 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=65 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in HADS Anxiety Total Score From Baseline to Week 12	-3.3 Scores on a scale Standard Deviation 4.08	-1.0 Scores on a scale Standard Deviation 3.03	—	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 2 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=28 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=66 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in HADS Depression Total Score From Baseline to Week 2	-1.6 Scores on a scale Standard Deviation 3.21	-0.5 Scores on a scale Standard Deviation 1.65	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 6 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=55 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in HADS Depression Total Score From Baseline to Week 6	-3.4 Scores on a scale Standard Deviation 3.78	-0.8 Scores on a scale Standard Deviation 2.80	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 12 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=64 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in HADS Depression Total Score From Baseline to Week 12	-3.7 Scores on a scale Standard Deviation 3.92	-0.7 Scores on a scale Standard Deviation 3.07	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100.

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=18 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=45 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 6	-0.0 Scores on a scale Standard Deviation 11.74	4.0 Scores on a scale Standard Deviation 8.37	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100.

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=21 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=49 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 12	2.4 Scores on a scale Standard Deviation 11.51	3.5 Scores on a scale Standard Deviation 9.64	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100.

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=18 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=45 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 6	5.0 Scores on a scale Standard Deviation 11.11	-0.9 Scores on a scale Standard Deviation 8.19	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100.

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=21 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=49 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 12	6.0 Scores on a scale Standard Deviation 13.07	0.7 Scores on a scale Standard Deviation 10.19	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Pain-related life interference (with family and marital functioning, work, social activities). The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no interference) to 6 (extreme interference).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=56 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): Interference of Pain (With Subjective Well-being) From Baseline to Week 6	-0.9 Scores on a scale Standard Deviation 1.24	-1.0 Scores on a scale Standard Deviation 1.06	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Pain-related life interference (with family and marital functioning, work, social activities). The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no interference) to 6 (extreme interference).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=64 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): Interference of Pain From Baseline to Week 12	-1.0 Scores on a scale Standard Deviation 1.37	-1.1 Scores on a scale Standard Deviation 1.13	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Appraisal of support received from spouse, family and significant others. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no support) to 6 (very much support).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=22 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=54 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): Support From Baseline to Week 6	0.5 Scores on a scale Standard Deviation 1.59	-0.4 Scores on a scale Standard Deviation 1.28	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Appraisal of support received from spouse, family and significant others. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no support) to 6 (very much support).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=59 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): Support Which the Patient Received From Baseline to Week 12	0.4 Scores on a scale Standard Deviation 1.90	-0.2 Scores on a scale Standard Deviation 1.54	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (not at all strong) to 6 (very strong).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=55 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 6	-1.0 Scores on a scale Standard Deviation 1.33	-1.2 Scores on a scale Standard Deviation 1.34	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=61 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 12	-1.2 Scores on a scale Standard Deviation 1.35	-1.5 Scores on a scale Standard Deviation 1.39	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Perceived life control and ability to solve problems and feelings of personal mastery and competence. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=55 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 6	0.2 Scores on a scale Standard Deviation 1.16	0.2 Scores on a scale Standard Deviation 1.14	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Perceived life control and ability to solve problems and feelings of personal mastery and competence. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=25 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=62 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 12	0.3 Scores on a scale Standard Deviation 1.57	0.4 Scores on a scale Standard Deviation 1.10	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Affective distress, including ratings of depressed mood, irritability, and tension. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no distress) to 6 (extreme distress).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=56 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 6	-0.5 Scores on a scale Standard Deviation 1.04	-0.3 Scores on a scale Standard Deviation 1.01	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Affective distress, including ratings of depressed mood, irritability, and tension. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no distress) to 6 (extreme distress).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=62 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 12	-0.8 Scores on a scale Standard Deviation 1.13	-0.5 Scores on a scale Standard Deviation 1.00	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Degree to which significant others display negative responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=54 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 6	-0.7 Scores on a scale Standard Deviation 2.16	-0.1 Scores on a scale Standard Deviation 0.87	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Degree to which significant others display negative responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=62 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 12	-0.3 Scores on a scale Standard Deviation 2.03	0.1 Scores on a scale Standard Deviation 0.73	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Degree to which significant others display solicitous responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=54 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 6	-0.2 Scores on a scale Standard Deviation 2.08	-0.2 Scores on a scale Standard Deviation 1.12	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Degree to which significant others display solicitous responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=62 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 12	0.2 Scores on a scale Standard Deviation 2.30	-0.2 Scores on a scale Standard Deviation 1.10	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Degree to which significant others display distracting responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=53 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): Degree to Which Significant Others Display Distracting Responses to the Patient's Pain Behaviors and Complaints From Baseline to Week 6	-0.1 Scores on a scale Standard Deviation 2.25	-0.1 Scores on a scale Standard Deviation 1.35	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Degree to which significant others display distracting responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=62 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): Degree to Which Significant Others Display Distracting Responses to the Patient's Pain Behaviors and Complaints From Baseline to Week 12	0.0 Scores on a scale Standard Deviation 2.43	-0.2 Scores on a scale Standard Deviation 1.19	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Frequency with which the patient engages in household chores. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=57 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 6	-0.1 Scores on a scale Standard Deviation 0.79	0.0 Scores on a scale Standard Deviation 1.24	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Frequency with which the patient engages in household chores. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=65 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 12	-0.1 Scores on a scale Standard Deviation 0.99	0.1 Scores on a scale Standard Deviation 1.29	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=21 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=54 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 6	0.3 Scores on a scale Standard Deviation 2.01	-1.2 Scores on a scale Standard Deviation 6.29	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=62 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 12	0.6 Scores on a scale Standard Deviation 2.37	-1.6 Scores on a scale Standard Deviation 10.24	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Frequency with which the patient engages in social activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=57 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 6	0.1 Scores on a scale Standard Deviation 0.70	0.1 Scores on a scale Standard Deviation 0.80	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Frequency with which the patient engages in social activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=65 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 12	0.3 Scores on a scale Standard Deviation 1.11	0.1 Scores on a scale Standard Deviation 0.64	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Frequency with which the patient engages in general activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=57 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 6	0.1 Scores on a scale Standard Deviation 0.60	-0.2 Scores on a scale Standard Deviation 1.66	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

Frequency with which the patient engages in general activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=65 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 12	0.3 Scores on a scale Standard Deviation 0.95	-0.3 Scores on a scale Standard Deviation 2.73	—	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 2 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=28 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=66 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Clinical Global Impression - Severity Pain From Baseline to Week 2	-0.4 Scores on a scale Standard Deviation 0.62	-0.5 Scores on a scale Standard Deviation 0.96	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 6 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=57 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Clinical Global Impression - Severity Pain From Baseline to Week 6	-0.8 Scores on a scale Standard Deviation 0.78	-0.7 Scores on a scale Standard Deviation 1.02	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

The change from baseline reflects the week 12 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=27 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=66 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Clinical Global Impression - Severity Pain From Baseline to Week 12	-1.0 Scores of a scale Standard Deviation 0.94	-0.8 Scores of a scale Standard Deviation 1.08	—	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 2 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=28 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=65 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Hamilton Depression Score From Baseline to Week 2	-4.5 Scores on a scale Standard Deviation 5.29	-0.2 Scores on a scale Standard Deviation 2.50	—	—

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=57 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Hamilton Depression Score From Baseline to Week 6	-9.3 Scores of a scale Standard Deviation 4.99	-1.5 Scores of a scale Standard Deviation 2.89	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5

The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=27 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=66 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change in Hamilton Depression Score From Baseline to Week 12	-9.7 Scores on a scale Standard Deviation 5.50	-0.8 Scores on a scale Standard Deviation 3.30	—	—

SECONDARY outcome

Timeframe: Week 2

Population: All patients receiving at least one dose of study medication and having data at week 2.

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=28 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=70 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Suicidal Thoughts by BDI-II at Week 2 No thoughts of killing myself	27 Participants	67 Participants	—	—
Suicidal Thoughts by BDI-II at Week 2 Thoughts of killing myself	1 Participants	3 Participants	—	—
Suicidal Thoughts by BDI-II at Week 2 Like to kill myself	0 Participants	0 Participants	—	—
Suicidal Thoughts by BDI-II at Week 2 Kill myself if chance	0 Participants	0 Participants	—	—
Suicidal Thoughts by BDI-II at Week 2 Missing	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Week 6

Population: All patients receiving at least one dose of study medication and having data at week 6.

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=59 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Suicidal Thoughts by BDI-II at Week 6 Thoughts of killing myself	1 Participants	2 Participants	—	—
Suicidal Thoughts by BDI-II at Week 6 Like to kill myself	0 Participants	0 Participants	—	—
Suicidal Thoughts by BDI-II at Week 6 Kill myself if chance	0 Participants	0 Participants	—	—
Suicidal Thoughts by BDI-II at Week 6 Missing	1 Participants	0 Participants	—	—
Suicidal Thoughts by BDI-II at Week 6 No thoughts of killing myself	22 Participants	57 Participants	—	—

SECONDARY outcome

Timeframe: Week 12

Population: All patients receiving at least one dose of study medication and having data at week 12.

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=26 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=65 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Suicidal Thoughts by BDI-II at Week 12 No thoughts of killing myself	24 Participants	63 Participants	—	—
Suicidal Thoughts by BDI-II at Week 12 Thoughts of killing myself	2 Participants	0 Participants	—	—
Suicidal Thoughts by BDI-II at Week 12 Like to kill myself	0 Participants	0 Participants	—	—
Suicidal Thoughts by BDI-II at Week 12 Kill myself if chance	0 Participants	0 Participants	—	—
Suicidal Thoughts by BDI-II at Week 12 Missing	0 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: Week 2

Population: All patients receiving at least one dose of study medication and having data at week 2.

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=28 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=68 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Suicidal Thoughts or Behaviours by HAMD-17 at Week 2 Absent	26 Participants	68 Participants	—	—
Suicidal Thoughts or Behaviours by HAMD-17 at Week 2 Feels life is not worth living	2 Participants	0 Participants	—	—
Suicidal Thoughts or Behaviours by HAMD-17 at Week 2 Thoughts of possible death to self	0 Participants	0 Participants	—	—
Suicidal Thoughts or Behaviours by HAMD-17 at Week 2 Suicidal ideas or gestures	0 Participants	0 Participants	—	—
Suicidal Thoughts or Behaviours by HAMD-17 at Week 2 Attempts at suicide	0 Participants	0 Participants	—	—
Suicidal Thoughts or Behaviours by HAMD-17 at Week 2 Missing	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Week 6

Population: All patients receiving at least one dose of study medication and having data at week 6.

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=24 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=60 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Suicidal Thoughts or Behaviours by HAMD-17 at Week 6 Absent	22 Participants	60 Participants	—	—
Suicidal Thoughts or Behaviours by HAMD-17 at Week 6 Feels life is not worth living	2 Participants	0 Participants	—	—
Suicidal Thoughts or Behaviours by HAMD-17 at Week 6 Thoughts of possible death to self	0 Participants	0 Participants	—	—
Suicidal Thoughts or Behaviours by HAMD-17 at Week 6 Suicidal ideas or gestures	0 Participants	0 Participants	—	—
Suicidal Thoughts or Behaviours by HAMD-17 at Week 6 Attempts at suicide	0 Participants	0 Participants	—	—
Suicidal Thoughts or Behaviours by HAMD-17 at Week 6 Missing	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Week 12

Population: All patients receiving at least one dose of study medication and having data at week 12.

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=27 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=66 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Suicidal Thoughts or Behaviours by HAMD-17 at Week 12 Absent	26 Participants	66 Participants	—	—
Suicidal Thoughts or Behaviours by HAMD-17 at Week 12 Feels life is not worth living	1 Participants	0 Participants	—	—
Suicidal Thoughts or Behaviours by HAMD-17 at Week 12 Thoughts of possible death to self	0 Participants	0 Participants	—	—
Suicidal Thoughts or Behaviours by HAMD-17 at Week 12 Suicidal ideas or gestures	0 Participants	0 Participants	—	—
Suicidal Thoughts or Behaviours by HAMD-17 at Week 12 Attempts at suicide	0 Participants	0 Participants	—	—
Suicidal Thoughts or Behaviours by HAMD-17 at Week 12 Missing	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication and having data of fasting blood glucose at baseline and at week 12.

Ancova analysis controlling for baseline and insulin intake

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=15 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=42 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change of Fasting Blood Glucose From Baseline at Week 12	13.0 mg/dL Interval -37.7 to 63.7	14.9 mg/dL Interval -12.0 to 41.8	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication and having data of HbA1c at baseline and at week 12.

Ancova analysis controlling for baseline and insulin intake

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=27 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=66 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline at Week 12	0.1 percent Interval -0.3 to 0.4	0.1 percent Interval -0.1 to 0.3	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication.

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=30 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=75 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change of Systolic Blood Pressure From Baseline at Week 12	-2.8 mmHg Standard Deviation 17.40	-0.4 mmHg Standard Deviation 16.04	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication.

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=30 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=75 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change of Diastolic Blood Pressure From Baseline at Week 12	-0.6 mmHg Standard Deviation 8.86	2.2 mmHg Standard Deviation 10.03	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: All patients receiving at least one dose of study medication.

Outcome measures

Measure	With Major Depressive Disorder (MDD+) n=30 Participants Patients with diabetic polyneuropathy and depression	Without Major Depressive Disorder (MDD-) n=75 Participants Patients with diabetic polyneuropathy and no depression	MDD- Non-Responder MDD-, not treatment responder. 60mg, after week 5 120mg DLX	MDD+ Non-Responder MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Change of Pulse Rate From Baseline at Week 12	2.9 beats per minute (bpm) Standard Deviation 9.40	2.4 beats per minute (bpm) Standard Deviation 9.53	—	—

Adverse Events

Without Major Depressive Disorder (MDD-)

Serious events: 4 serious events

Other events: 28 other events

Deaths: 0 deaths

With Major Depressive Disorder (MDD+)

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Without Major Depressive Disorder (MDD-) n=78 participants at risk Patients with diabetic polyneuropathy and no depression	With Major Depressive Disorder (MDD+) n=30 participants at risk Patients with diabetic polyneuropathy and depression
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	1.3% 1/78 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.	0.00% 0/30 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.
Nervous system disorders Carotid artery stenosis	1.3% 1/78 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.	0.00% 0/30 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.
Nervous system disorders Cerebrovascular accident	1.3% 1/78 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.	0.00% 0/30 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.
Nervous system disorders Transient ischaemic attack	1.3% 1/78 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.	0.00% 0/30 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.
Cardiac disorders Acute myocardial infarction	0.00% 0/78 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.	3.3% 1/30 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.
Cardiac disorders Atrial flutter	0.00% 0/78 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.	3.3% 1/30 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.
Cardiac disorders Cardiac failure	1.3% 1/78 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.	0.00% 0/30 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.
Injury, poisoning and procedural complications Fall	1.3% 1/78 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.	0.00% 0/30 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.
Injury, poisoning and procedural complications Femoral neck fracture	1.3% 1/78 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.	0.00% 0/30 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.

Other adverse events

Measure	Without Major Depressive Disorder (MDD-) n=78 participants at risk Patients with diabetic polyneuropathy and no depression	With Major Depressive Disorder (MDD+) n=30 participants at risk Patients with diabetic polyneuropathy and depression
Skin and subcutaneous tissue disorders Hyperhidrosis	10.3% 8/78 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.	20.0% 6/30 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.
Gastrointestinal disorders Nausea	14.1% 11/78 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.	10.0% 3/30 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.
Gastrointestinal disorders Constipation	2.6% 2/78 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.	13.3% 4/30 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.
Gastrointestinal disorders Diarrhoea	9.0% 7/78 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.	0.00% 0/30 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.
General disorders Fatigue	5.1% 4/78 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.	10.0% 3/30 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.
Ear and labyrinth disorders Vertigo	1.3% 1/78 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.	10.0% 3/30 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.
Musculoskeletal and connective tissue disorders Back pain	5.1% 4/78 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.	3.3% 1/30 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.
Musculoskeletal and connective tissue disorders Arthralgia	2.6% 2/78 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.	6.7% 2/30 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.
Nervous system disorders Headache	2.6% 2/78 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.	6.7% 2/30 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.
Renal and urinary disorders Micturition disorder	0.00% 0/78 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.	6.7% 2/30 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.
Psychiatric disorders Sleep disorder	1.3% 1/78 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.	6.7% 2/30 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.
Infections and infestations Urinary tract infection	0.00% 0/78 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.	6.7% 2/30 • 14 weeks 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
• Publication restrictions are in place

Restriction type: OTHER