Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 77 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00844194
Recruitment Status : Completed
First Posted : February 16, 2009
Results First Posted : October 31, 2011
Last Update Posted : May 15, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetic Neuropathies
Depressive Disorder, Major
Interventions Drug: Duloxetine 60 mg QD
Drug: Duloxetine 30 mg QD
Drug: Duloxetine 90 mg QD
Drug: Duloxetine 120 mg QD
Enrollment 108
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description Patients with diabetic polyneuropathy and no depression Patients with diabetic polyneuropathy and depression
Period Title: Overall Study
Started 78 30
Completed 53 22
Not Completed 25 8
Reason Not Completed
Adverse Event             17             5
Protocol Violation             1             1
Lost to Follow-up             1             1
Withdrawal by Subject             2             1
Lack of Efficacy             3             0
Other reason (not specified)             1             0
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+) Total
Hide Arm/Group Description Patients with diabetic polyneuropathy and no depression Patients with diabetic polyneuropathy and depression Total of all reporting groups
Overall Number of Baseline Participants 78 30 108
Hide Baseline Analysis Population Description
All patients receiving at least one dose of study medication (TS).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants 30 participants 108 participants
67.5  (10.2) 66.6  (9.8) 67.3  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 30 participants 108 participants
Female
36
  46.2%
15
  50.0%
51
  47.2%
Male
42
  53.8%
15
  50.0%
57
  52.8%
1.Primary Outcome
Title Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 65 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.4  (1.91) -2.2  (2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Without Major Depressive Disorder (MDD-)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments with last observation carried forward (LOCF)
Method of Estimation Estimation Parameter LSmean
Estimated Value -1.49
Confidence Interval (2-Sided) 95%
-1.89 to -1.10
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection With Major Depressive Disorder (MDD+)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSmean
Estimated Value -1.67
Confidence Interval (2-Sided) 95%
-2.30 to -1.04
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title MDD- Responder MDD+ Responder MDD- Non-Responder MDD+ Non-Responder
Hide Arm/Group Description:
MDD-, treatment responder. 60mg Duloxetine (DLX) for 12 weeks
MDD+, treatment responder. 60mg Duloxetine (DLX) for 12 weeks
MDD-, not treatment responder. 60mg, after week 5 120mg DLX
MDD+, not treatment responder. 60mg, after week 5 120mg DLX
Overall Number of Participants Analyzed 40 16 15 6
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.7  (1.65) -2.2  (2.0) -0.9  (2.5) -2.6  (3.31)
3.Secondary Outcome
Title Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 57 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.2  (1.88) -2.0  (1.96)
4.Secondary Outcome
Title Change in BPI Worst Pain During Treatment From Baseline to Week 2
Hide Description 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).
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 66 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-2.2  (2.27) -1.9  (2.19)
5.Secondary Outcome
Title Change in Worst Pain (BPI) From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 57 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-2.6  (2.36) -3.3  (2.56)
6.Secondary Outcome
Title Change in Worst Pain (BPI) From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 64 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-2.8  (2.55) -3.2  (3.41)
7.Secondary Outcome
Title Change in Least Pain (BPI) From Baseline to Week 2
Hide Description 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).
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 66 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.1  (2.35) -0.2  (1.7)
8.Secondary Outcome
Title Change in Least Pain During Treatment (BPI) From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 57 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.7  (1.92) -1.3  (2.1)
9.Secondary Outcome
Title Change in Least Pain (BPI) From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 65 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.5  (2.13) -1.1  (2.07)
10.Secondary Outcome
Title Change in Average Pain (BPI) From Baseline to Week 2
Hide Description 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).
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 66 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.6  (1.87) -1.1  (1.63)
11.Secondary Outcome
Title Change in Average Pain During Treatment (BPI) From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 57 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-2.6  (1.92) -2.6  (2.0)
12.Secondary Outcome
Title Change in Average Pain (BPI) From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 65 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-2.4  (1.88) -2.2  (2.07)
13.Secondary Outcome
Title Number of Patients With a Reduction in BPI Average Pain at Week 2
Hide Description [Not Specified]
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 71 30
Measure Type: Number
Unit of Measure: Participants
>=30% 29 9
>=50% 19 3
Missing 5 2
14.Secondary Outcome
Title Number of Patients With a Reduction in BPI Average Pain at Week 6
Hide Description [Not Specified]
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 71 30
Measure Type: Number
Unit of Measure: Participants
>=30% 42 17
>=50% 30 12
Missing 14 6
15.Secondary Outcome
Title Number of Patients With a Reduction in BPI Average Pain at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 71 30
Measure Type: Number
Unit of Measure: Participants
>=30% 42 17
>=50% 30 11
Missing 6 4
16.Secondary Outcome
Title Change in Pain During Treatment (BPI) From Baseline to Week 2
Hide Description 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).
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 66 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.4  (2.34) -1.0  (2.06)
17.Secondary Outcome
Title Change in Pain (BPI) From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 57 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-2.0  (2.27) -1.7  (3.01)
18.Secondary Outcome
Title Change in Pain During Treatment (BPI) From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 65 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.7  (2.6) -1.5  (2.21)
19.Secondary Outcome
Title Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 2
Hide Description 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).
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 62 25
Mean (Standard Deviation)
Unit of Measure: scores on a scale
21.5  (33.87) 18.0  (35.0)
20.Secondary Outcome
Title Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 51 23
Mean (Standard Deviation)
Unit of Measure: scores on a scale
23.5  (37.3) 31.7  (45.49)
21.Secondary Outcome
Title Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 54 24
Mean (Standard Deviation)
Unit of Measure: scores on a scale
30.2  (35.85) 22.9  (33.55)
22.Secondary Outcome
Title Change in Interference of Pain With General Activity (BPI) From Baseline to Week 2
Hide Description 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).
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 67 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.6  (2.5) -1.1  (2.02)
23.Secondary Outcome
Title Change in Interference of Pain With General Activity (BPI) From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 57 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.8  (2.89) -2.5  (3.16)
24.Secondary Outcome
Title Change in Interference of Pain With General Activity (BPI) From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 65 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-2.4  (2.53) -2.7  (2.76)
25.Secondary Outcome
Title Change in Interference of Pain With Mood (BPI) From Baseline to Week 2
Hide Description 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).
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 66 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.1  (2.3) -1.5  (1.73)
26.Secondary Outcome
Title Change in Interference of Pain With Mood (BPI) From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 57 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.4  (2.4) -3.1  (3.08)
27.Secondary Outcome
Title Change in Interference of Pain With Mood (BPI) From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 65 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.2  (2.68) -3.0  (3.28)
28.Secondary Outcome
Title Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 2
Hide Description 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).
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 66 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.9  (2.03) -1.0  (2.19)
29.Secondary Outcome
Title Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 56 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.3  (2.55) -2.1  (3.26)
30.Secondary Outcome
Title Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 65 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.9  (2.86) -2.4  (3.11)
31.Secondary Outcome
Title Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 2
Hide Description 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).
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 65 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.9  (1.76) -0.1  (2.34)
32.Secondary Outcome
Title Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 57 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.1  (2.47) -1.3  (2.92)
33.Secondary Outcome
Title Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 64 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.4  (1.89) -1.8  (2.67)
34.Secondary Outcome
Title Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 2
Hide Description 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).
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 67 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.5  (2.68) -0.1  (2.80)
35.Secondary Outcome
Title Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 57 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.6  (2.64) -1.7  (2.60)
36.Secondary Outcome
Title Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 64 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.4  (2.42) -1.7  (2.71)
37.Secondary Outcome
Title Change in Interference of Pain With Sleep (BPI) From Baseline to Week 2
Hide Description 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).
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 66 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.8  (3.21) -1.0  (2.46)
38.Secondary Outcome
Title Change in Interference of Pain With Sleep (BPI) From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 57 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.1  (3.50) -1.5  (3.44)
39.Secondary Outcome
Title Change in Interference of Pain With Sleep (BPI) From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 65 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.5  (2.53) -1.9  (3.05)
40.Secondary Outcome
Title Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 2
Hide Description 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).
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 67 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.7  (2.06) -0.6  (1.97)
41.Secondary Outcome
Title Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 57 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.2  (2.52) -2.2  (2.90)
42.Secondary Outcome
Title Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 65 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.9  (2.93) -2.1  (2.30)
43.Secondary Outcome
Title Patient Global Impression - Improvement (PGI-I) at Week 2
Hide Description 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).
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 67 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
3.0  (1.01) 3.2  (0.82)
44.Secondary Outcome
Title Patient Global Impression - Improvement (PGI-I) at Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 57 23
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
2.5  (0.87) 2.5  (1.04)
45.Secondary Outcome
Title Patient Global Impression - Improvement (PGI-I) at Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 64 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
2.5  (1.35) 2.7  (1.29)
46.Secondary Outcome
Title Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 2
Hide Description 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.
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 63 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.9  (3.61) -3.1  (5.79)
47.Secondary Outcome
Title Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 6
Hide Description 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.
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 50 23
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.8  (5.93) -7.3  (7.05)
48.Secondary Outcome
Title Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 12
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 58 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.6  (6.02) -7.8  (7.25)
49.Secondary Outcome
Title Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Total Score From Baseline to Week 2
Hide Description 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).
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 67 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.7  (2.23) -1.2  (2.94)
50.Secondary Outcome
Title Change in HADS Anxiety Total Score From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 56 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.8  (2.98) -2.2  (3.03)
51.Secondary Outcome
Title Change in HADS Anxiety Total Score From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 65 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.0  (3.03) -3.3  (4.08)
52.Secondary Outcome
Title Change in HADS Depression Total Score From Baseline to Week 2
Hide Description 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).
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 66 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.5  (1.65) -1.6  (3.21)
53.Secondary Outcome
Title Change in HADS Depression Total Score From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 55 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.8  (2.80) -3.4  (3.78)
54.Secondary Outcome
Title Change in HADS Depression Total Score From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 64 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.7  (3.07) -3.7  (3.92)
55.Secondary Outcome
Title Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 6
Hide Description 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.
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 45 18
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
4.0  (8.37) -0.0  (11.74)
56.Secondary Outcome
Title Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 12
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 49 21
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
3.5  (9.64) 2.4  (11.51)
57.Secondary Outcome
Title Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 6
Hide Description 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.
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 45 18
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.9  (8.19) 5.0  (11.11)
58.Secondary Outcome
Title Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 12
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 49 21
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.7  (10.19) 6.0  (13.07)
59.Secondary Outcome
Title Change in Multidimensional Pain Inventory (MPI): Interference of Pain (With Subjective Well-being) From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 56 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.0  (1.06) -0.9  (1.24)
60.Secondary Outcome
Title Change in Multidimensional Pain Inventory (MPI): Interference of Pain From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 64 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.1  (1.13) -1.0  (1.37)
61.Secondary Outcome
Title Change in Multidimensional Pain Inventory (MPI): Support From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 54 22
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.4  (1.28) 0.5  (1.59)
62.Secondary Outcome
Title Change in Multidimensional Pain Inventory (MPI): Support Which the Patient Received From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 59 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.2  (1.54) 0.4  (1.90)
63.Secondary Outcome
Title Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 55 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.2  (1.34) -1.0  (1.33)
64.Secondary Outcome
Title Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 12
Hide Description The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 61 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.5  (1.39) -1.2  (1.35)
65.Secondary Outcome
Title Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 55 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.2  (1.14) 0.2  (1.16)
66.Secondary Outcome
Title Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 62 25
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.4  (1.10) 0.3  (1.57)
67.Secondary Outcome
Title Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 56 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.3  (1.01) -0.5  (1.04)
68.Secondary Outcome
Title Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 62 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.5  (1.00) -0.8  (1.13)
69.Secondary Outcome
Title Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 54 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.1  (0.87) -0.7  (2.16)
70.Secondary Outcome
Title Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 62 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.1  (0.73) -0.3  (2.03)
71.Secondary Outcome
Title Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 54 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.2  (1.12) -0.2  (2.08)
72.Secondary Outcome
Title Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 62 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.2  (1.10) 0.2  (2.30)
73.Secondary Outcome
Title 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
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 53 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.1  (1.35) -0.1  (2.25)
74.Secondary Outcome
Title 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
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 62 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.2  (1.19) 0.0  (2.43)
75.Secondary Outcome
Title Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 57 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.0  (1.24) -0.1  (0.79)
76.Secondary Outcome
Title Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 65 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.1  (1.29) -0.1  (0.99)
77.Secondary Outcome
Title Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 54 21
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.2  (6.29) 0.3  (2.01)
78.Secondary Outcome
Title Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 62 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.6  (10.24) 0.6  (2.37)
79.Secondary Outcome
Title Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 57 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.1  (0.80) 0.1  (0.70)
80.Secondary Outcome
Title Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 65 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.1  (0.64) 0.3  (1.11)
81.Secondary Outcome
Title Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 57 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.2  (1.66) 0.1  (0.60)
82.Secondary Outcome
Title Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 65 26
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.3  (2.73) 0.3  (0.95)
83.Secondary Outcome
Title Change in Clinical Global Impression - Severity Pain From Baseline to Week 2
Hide Description 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).
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 66 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.5  (0.96) -0.4  (0.62)
84.Secondary Outcome
Title Change in Clinical Global Impression - Severity Pain From Baseline to Week 6
Hide Description 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).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 57 24
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.7  (1.02) -0.8  (0.78)
85.Secondary Outcome
Title Change in Clinical Global Impression - Severity Pain From Baseline to Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 66 27
Mean (Standard Deviation)
Unit of Measure: Scores of a scale
-0.8  (1.08) -1.0  (0.94)
86.Secondary Outcome
Title Change in Hamilton Depression Score From Baseline to Week 2
Hide Description 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.
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 65 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.2  (2.50) -4.5  (5.29)
87.Secondary Outcome
Title Change in Hamilton Depression Score From Baseline to Week 6
Hide Description 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.
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 57 24
Mean (Standard Deviation)
Unit of Measure: Scores of a scale
-1.5  (2.89) -9.3  (4.99)
88.Secondary Outcome
Title Change in Hamilton Depression Score From Baseline to Week 12
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 66 27
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.8  (3.30) -9.7  (5.50)
89.Secondary Outcome
Title Suicidal Thoughts by BDI-II at Week 2
Hide Description [Not Specified]
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
All patients receiving at least one dose of study medication and having data at week 2.
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 70 28
Measure Type: Number
Unit of Measure: Participants
No thoughts of killing myself 67 27
Thoughts of killing myself 3 1
Like to kill myself 0 0
Kill myself if chance 0 0
Missing 0 0
90.Secondary Outcome
Title Suicidal Thoughts by BDI-II at Week 6
Hide Description [Not Specified]
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All patients receiving at least one dose of study medication and having data at week 6.
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 59 24
Measure Type: Number
Unit of Measure: Participants
No thoughts of killing myself 57 22
Thoughts of killing myself 2 1
Like to kill myself 0 0
Kill myself if chance 0 0
Missing 0 1
91.Secondary Outcome
Title Suicidal Thoughts by BDI-II at Week 12
Hide Description [Not Specified]
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All patients receiving at least one dose of study medication and having data at week 12.
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 65 26
Measure Type: Number
Unit of Measure: Participants
No thoughts of killing myself 63 24
Thoughts of killing myself 0 2
Like to kill myself 0 0
Kill myself if chance 0 0
Missing 2 0
92.Secondary Outcome
Title Suicidal Thoughts or Behaviours by HAMD-17 at Week 2
Hide Description [Not Specified]
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
All patients receiving at least one dose of study medication and having data at week 2.
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 68 28
Measure Type: Number
Unit of Measure: Participants
Absent 68 26
Feels life is not worth living 0 2
Thoughts of possible death to self 0 0
Suicidal ideas or gestures 0 0
Attempts at suicide 0 0
Missing 0 0
93.Secondary Outcome
Title Suicidal Thoughts or Behaviours by HAMD-17 at Week 6
Hide Description [Not Specified]
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All patients receiving at least one dose of study medication and having data at week 6.
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 60 24
Measure Type: Number
Unit of Measure: Participants
Absent 60 22
Feels life is not worth living 0 2
Thoughts of possible death to self 0 0
Suicidal ideas or gestures 0 0
Attempts at suicide 0 0
Missing 0 0
94.Secondary Outcome
Title Suicidal Thoughts or Behaviours by HAMD-17 at Week 12
Hide Description [Not Specified]
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All patients receiving at least one dose of study medication and having data at week 12.
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 66 27
Measure Type: Number
Unit of Measure: Participants
Absent 66 26
Feels life is not worth living 0 1
Thoughts of possible death to self 0 0
Suicidal ideas or gestures 0 0
Attempts at suicide 0 0
Missing 0 0
95.Secondary Outcome
Title Change of Fasting Blood Glucose From Baseline at Week 12
Hide Description Ancova analysis controlling for baseline and insulin intake
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All patients receiving at least one dose of study medication and having data of fasting blood glucose at baseline and at week 12.
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 42 15
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
14.9
(-12.0 to 41.8)
13.0
(-37.7 to 63.7)
96.Secondary Outcome
Title Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline at Week 12
Hide Description Ancova analysis controlling for baseline and insulin intake
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All patients receiving at least one dose of study medication and having data of HbA1c at baseline and at week 12.
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 66 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent
0.1
(-0.1 to 0.3)
0.1
(-0.3 to 0.4)
97.Secondary Outcome
Title Change of Systolic Blood Pressure From Baseline at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All patients receiving at least one dose of study medication.
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 75 30
Mean (Standard Deviation)
Unit of Measure: mmHg
-0.4  (16.04) -2.8  (17.40)
98.Secondary Outcome
Title Change of Diastolic Blood Pressure From Baseline at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All patients receiving at least one dose of study medication.
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 75 30
Mean (Standard Deviation)
Unit of Measure: mmHg
2.2  (10.03) -0.6  (8.86)
99.Secondary Outcome
Title Change of Pulse Rate From Baseline at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All patients receiving at least one dose of study medication.
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description:
Patients with diabetic polyneuropathy and no depression
Patients with diabetic polyneuropathy and depression
Overall Number of Participants Analyzed 75 30
Mean (Standard Deviation)
Unit of Measure: beats per minute (bpm)
2.4  (9.53) 2.9  (9.40)
Time Frame 14 weeks
Adverse Event Reporting Description 12 Weeks treatment period (6 weeks for Treatment Phase 1 and 6 weeks for Treatment Phase 2) and a 2-week taper phase.
 
Arm/Group Title Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Hide Arm/Group Description Patients with diabetic polyneuropathy and no depression Patients with diabetic polyneuropathy and depression
All-Cause Mortality
Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Affected / at Risk (%) Affected / at Risk (%)
Total   4/78 (5.13%)   2/30 (6.67%) 
Cardiac disorders     
Acute myocardial infarction  1  0/78 (0.00%)  1/30 (3.33%) 
Atrial flutter  1  0/78 (0.00%)  1/30 (3.33%) 
Cardiac failure  1  1/78 (1.28%)  0/30 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  1/78 (1.28%)  0/30 (0.00%) 
Femoral neck fracture  1  1/78 (1.28%)  0/30 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Meningioma  1  1/78 (1.28%)  0/30 (0.00%) 
Nervous system disorders     
Carotid artery stenosis  1  1/78 (1.28%)  0/30 (0.00%) 
Cerebrovascular accident  1  1/78 (1.28%)  0/30 (0.00%) 
Transient ischaemic attack  1  1/78 (1.28%)  0/30 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, Meddra 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Without Major Depressive Disorder (MDD-) With Major Depressive Disorder (MDD+)
Affected / at Risk (%) Affected / at Risk (%)
Total   28/78 (35.90%)   16/30 (53.33%) 
Ear and labyrinth disorders     
Vertigo  1  1/78 (1.28%)  3/30 (10.00%) 
Gastrointestinal disorders     
Nausea  1  11/78 (14.10%)  3/30 (10.00%) 
Constipation  1  2/78 (2.56%)  4/30 (13.33%) 
Diarrhoea  1  7/78 (8.97%)  0/30 (0.00%) 
General disorders     
Fatigue  1  4/78 (5.13%)  3/30 (10.00%) 
Infections and infestations     
Urinary tract infection  1  0/78 (0.00%)  2/30 (6.67%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  4/78 (5.13%)  1/30 (3.33%) 
Arthralgia  1  2/78 (2.56%)  2/30 (6.67%)