Trial Outcomes & Findings for A Long-term Study for the Treatment of Painful Diabetic Neuropathy (NCT NCT00641719)
NCT ID: NCT00641719
Last Updated: 2011-03-31
Results Overview
See the Reported Adverse Events section for details.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
258 participants
Primary outcome timeframe
baseline through 1 year
Results posted on
2011-03-31
Participant Flow
This study, F1J-JE-HMFY (Study HMFY), is an open-label, long-term extension study of double-blind placebo-controlled study F1J-JE-HMFX (Study HMFX) (NCT00552175).
Prior to start of extension study (HMFY), all participants in Study HMFX were re-randomized to duloxetine 40 or 60 mg regardless of the treatment they received in Study HMFX. Baseline values for the extension study HMFY represent those of 40- and 60-mg groups after re-randomization of participants.
Participant milestones
| Measure |
Duloxetine 40 mg
Duloxetine 40 mg once daily (QD), orally (PO), 1 year
|
Duloxetine 60 mg
Duloxetine 60 mg QD, PO, 1 year
|
|---|---|---|
|
Overall Study
STARTED
|
129
|
129
|
|
Overall Study
COMPLETED
|
99
|
92
|
|
Overall Study
NOT COMPLETED
|
30
|
37
|
Reasons for withdrawal
| Measure |
Duloxetine 40 mg
Duloxetine 40 mg once daily (QD), orally (PO), 1 year
|
Duloxetine 60 mg
Duloxetine 60 mg QD, PO, 1 year
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
|
Overall Study
Adverse Event
|
24
|
29
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
|
Overall Study
Reason Not Specified
|
1
|
2
|
Baseline Characteristics
A Long-term Study for the Treatment of Painful Diabetic Neuropathy
Baseline characteristics by cohort
| Measure |
Duloxetine 40 mg
n=129 Participants
Duloxetine 40 mg once daily (QD), orally (PO), 1 year
|
Duloxetine 60 mg
n=129 Participants
Duloxetine 60 mg QD, PO, 1 year
|
Total
n=258 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
60.2 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
60.0 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
60.1 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
|
129 participants
n=5 Participants
|
129 participants
n=7 Participants
|
258 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
129 participants
n=5 Participants
|
129 participants
n=7 Participants
|
258 participants
n=5 Participants
|
|
Duration of Diabetes
Less Than 5 Years
|
23 participants
n=5 Participants
|
25 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Duration of Diabetes
5 to 10 Years
|
27 participants
n=5 Participants
|
23 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Duration of Diabetes
Greater Than or Equal to 10 Years
|
76 participants
n=5 Participants
|
79 participants
n=7 Participants
|
155 participants
n=5 Participants
|
|
Duration of Diabetes
Unknown
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Type of Diabetes
Type I
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Type of Diabetes
Type II
|
121 participants
n=5 Participants
|
125 participants
n=7 Participants
|
246 participants
n=5 Participants
|
|
Height
|
163.69 centimeters (cm)
STANDARD_DEVIATION 9.04 • n=5 Participants
|
165.12 centimeters (cm)
STANDARD_DEVIATION 7.75 • n=7 Participants
|
164.41 centimeters (cm)
STANDARD_DEVIATION 8.44 • n=5 Participants
|
|
Weight
|
63.91 kilograms (kg)
STANDARD_DEVIATION 12.13 • n=5 Participants
|
64.98 kilograms (kg)
STANDARD_DEVIATION 11.57 • n=7 Participants
|
64.45 kilograms (kg)
STANDARD_DEVIATION 11.84 • n=5 Participants
|
|
Body Mass Index (BMI)
|
23.79 kilograms/meters squared (kg/m^2)
STANDARD_DEVIATION 3.77 • n=5 Participants
|
23.77 kilograms/meters squared (kg/m^2)
STANDARD_DEVIATION 3.49 • n=7 Participants
|
23.78 kilograms/meters squared (kg/m^2)
STANDARD_DEVIATION 3.62 • n=5 Participants
|
|
Duration of Diabetic Neuropathy
|
3.91 years
STANDARD_DEVIATION 3.16 • n=5 Participants
|
4.29 years
STANDARD_DEVIATION 3.91 • n=7 Participants
|
4.10 years
STANDARD_DEVIATION 3.55 • n=5 Participants
|
|
Patient's Global Impressions of Improvement (PGI-I) Rate
|
3.0 units on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
3.1 units on a scale
STANDARD_DEVIATION 1.1 • n=7 Participants
|
3.1 units on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Beck Depression Inventory - II (BDI-II)
|
6.1 units on a scale
STANDARD_DEVIATION 6.4 • n=5 Participants
|
6.1 units on a scale
STANDARD_DEVIATION 6.4 • n=7 Participants
|
6.1 units on a scale
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Brief Pain Inventory (BPI) Interference
General Activity
|
2.5 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 2.2 • n=7 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Brief Pain Inventory (BPI) Interference
Mood
|
2.3 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
2.4 units on a scale
STANDARD_DEVIATION 2.2 • n=7 Participants
|
2.3 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Brief Pain Inventory (BPI) Interference
Walking Ability
|
2.2 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
2.3 units on a scale
STANDARD_DEVIATION 2.1 • n=7 Participants
|
2.3 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Brief Pain Inventory (BPI) Interference
Normal Work
|
2.3 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
2.3 units on a scale
STANDARD_DEVIATION 2.2 • n=7 Participants
|
2.3 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Brief Pain Inventory (BPI) Interference
Relation to People
|
1.6 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
1.9 units on a scale
STANDARD_DEVIATION 2.1 • n=7 Participants
|
1.8 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Brief Pain Inventory (BPI) Interference
Sleep
|
2.2 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 2.4 • n=7 Participants
|
2.3 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Brief Pain Inventory (BPI) Interference
Enjoyment of Life
|
1.9 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 2.1 • n=7 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Brief Pain Inventory (BPI) Interference
Average Interference Score
|
2.14 units on a scale
STANDARD_DEVIATION 2.09 • n=5 Participants
|
2.32 units on a scale
STANDARD_DEVIATION 2.06 • n=7 Participants
|
2.23 units on a scale
STANDARD_DEVIATION 2.07 • n=5 Participants
|
|
Brief Pain Inventory (BPI) - Pain Severity
Worst Pain
|
4.7 units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 2.0 • n=7 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Brief Pain Inventory (BPI) - Pain Severity
Least Pain
|
2.8 units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
3.1 units on a scale
STANDARD_DEVIATION 2.1 • n=7 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Brief Pain Inventory (BPI) - Pain Severity
Average Pain
|
3.8 units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
4.0 units on a scale
STANDARD_DEVIATION 1.9 • n=7 Participants
|
3.9 units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Brief Pain Inventory (BPI) - Pain Severity
Pain Right Now
|
3.4 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
3.6 units on a scale
STANDARD_DEVIATION 2.1 • n=7 Participants
|
3.5 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline through 1 yearPopulation: All participants who received at least 1 dose of study drug.
See the Reported Adverse Events section for details.
Outcome measures
| Measure |
Duloxetine 40 mg
n=129 Participants
Duloxetine 40 mg once daily (QD), orally (PO), 1 year
|
Duloxetine 60 mg
n=129 Participants
Duloxetine 60 mg QD, PO, 1 year
|
|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
Adverse Events
|
126 participants
|
121 participants
|
|
Number of Participants Who Experienced an Adverse Event (AE)
Serious Adverse Events
|
11 participants
|
22 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Outcome measures
| Measure |
Duloxetine 40 mg
n=129 Participants
Duloxetine 40 mg once daily (QD), orally (PO), 1 year
|
Duloxetine 60 mg
n=128 Participants
Duloxetine 60 mg QD, PO, 1 year
|
|---|---|---|
|
Patient Global Impression of Improvement (PGI-I) Scale at One Year Endpoint.
|
2.1 units on a scale
Standard Deviation 0.9
|
2.1 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: baseline, 1 yearPopulation: Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Outcome measures
| Measure |
Duloxetine 40 mg
n=129 Participants
Duloxetine 40 mg once daily (QD), orally (PO), 1 year
|
Duloxetine 60 mg
n=128 Participants
Duloxetine 60 mg QD, PO, 1 year
|
|---|---|---|
|
Change From Baseline to One Year Endpoint for Patient Global Impression of Improvement (PGI-I) Scale
|
-0.9 units on a scale
Standard Deviation 1.1
|
-1.0 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now.
Outcome measures
| Measure |
Duloxetine 40 mg
n=129 Participants
Duloxetine 40 mg once daily (QD), orally (PO), 1 year
|
Duloxetine 60 mg
n=128 Participants
Duloxetine 60 mg QD, PO, 1 year
|
|---|---|---|
|
Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint
Worst Pain
|
2.4 units on a scale
Standard Deviation 1.9
|
2.6 units on a scale
Standard Deviation 2.0
|
|
Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint
Least Pain
|
1.3 units on a scale
Standard Deviation 1.5
|
1.5 units on a scale
Standard Deviation 1.5
|
|
Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint
Average Pain
|
1.8 units on a scale
Standard Deviation 1.5
|
1.9 units on a scale
Standard Deviation 1.6
|
|
Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint
Pain Right Now
|
1.7 units on a scale
Standard Deviation 1.6
|
1.7 units on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: baseline, 1 yearPopulation: Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now.
Outcome measures
| Measure |
Duloxetine 40 mg
n=129 Participants
Duloxetine 40 mg once daily (QD), orally (PO), 1 year
|
Duloxetine 60 mg
n=128 Participants
Duloxetine 60 mg QD, PO, 1 year
|
|---|---|---|
|
Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores
Pain Right Now
|
-1.8 units on a scale
Standard Deviation 1.7
|
-1.8 units on a scale
Standard Deviation 1.6
|
|
Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores
Worst Pain
|
-2.2 units on a scale
Standard Deviation 1.8
|
-2.3 units on a scale
Standard Deviation 1.9
|
|
Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores
Least Pain
|
-1.6 units on a scale
Standard Deviation 1.6
|
-1.6 units on a scale
Standard Deviation 1.6
|
|
Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores
Average Pain
|
-2.1 units on a scale
Standard Deviation 1.7
|
-2.1 units on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Duloxetine 40 mg
n=129 Participants
Duloxetine 40 mg once daily (QD), orally (PO), 1 year
|
Duloxetine 60 mg
n=128 Participants
Duloxetine 60 mg QD, PO, 1 year
|
|---|---|---|
|
Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint
Enjoyment of Life
|
1.2 units on a scale
Standard Deviation 1.6
|
1.3 units on a scale
Standard Deviation 1.5
|
|
Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint
General Activities
|
1.4 units on a scale
Standard Deviation 1.7
|
1.4 units on a scale
Standard Deviation 1.6
|
|
Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint
Mood
|
1.2 units on a scale
Standard Deviation 1.5
|
1.3 units on a scale
Standard Deviation 1.6
|
|
Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint
Walking Ability
|
1.4 units on a scale
Standard Deviation 1.7
|
1.3 units on a scale
Standard Deviation 1.5
|
|
Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint
Normal Work
|
1.2 units on a scale
Standard Deviation 1.7
|
1.3 units on a scale
Standard Deviation 1.5
|
|
Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint
Relation to People
|
1.0 units on a scale
Standard Deviation 1.5
|
1.1 units on a scale
Standard Deviation 1.4
|
|
Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint
Sleep
|
1.2 units on a scale
Standard Deviation 1.5
|
1.3 units on a scale
Standard Deviation 1.6
|
|
Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint
Average Score
|
1.21 units on a scale
Standard Deviation 1.52
|
1.28 units on a scale
Standard Deviation 1.48
|
SECONDARY outcome
Timeframe: baseline, 1 yearPopulation: Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Duloxetine 40 mg
n=129 Participants
Duloxetine 40 mg once daily (QD), orally (PO), 1 year
|
Duloxetine 60 mg
n=128 Participants
Duloxetine 60 mg QD, PO, 1 year
|
|---|---|---|
|
Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores
Normal Work
|
-1.0 units on a scale
Standard Deviation 1.8
|
-1.0 units on a scale
Standard Deviation 1.6
|
|
Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores
Average Score
|
-0.93 units on a scale
Standard Deviation 1.57
|
-1.00 units on a scale
Standard Deviation 1.48
|
|
Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores
General Activities
|
-1.1 units on a scale
Standard Deviation 1.8
|
-1.3 units on a scale
Standard Deviation 1.8
|
|
Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores
Mood
|
-1.1 units on a scale
Standard Deviation 1.8
|
-1.0 units on a scale
Standard Deviation 1.7
|
|
Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores
Walking Ability
|
-0.8 units on a scale
Standard Deviation 1.8
|
-1.0 units on a scale
Standard Deviation 1.6
|
|
Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores
Relation to People
|
-0.6 units on a scale
Standard Deviation 1.6
|
-0.7 units on a scale
Standard Deviation 1.6
|
|
Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores
Sleep
|
-1.0 units on a scale
Standard Deviation 2.1
|
-1.1 units on a scale
Standard Deviation 2.0
|
|
Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores
Enjoyment of Life
|
-0.8 units on a scale
Standard Deviation 1.7
|
-0.8 units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Outcome measures
| Measure |
Duloxetine 40 mg
n=129 Participants
Duloxetine 40 mg once daily (QD), orally (PO), 1 year
|
Duloxetine 60 mg
n=128 Participants
Duloxetine 60 mg QD, PO, 1 year
|
|---|---|---|
|
Beck Depression Inventory-II (BDI-II) Total Score at One Year Endpoint
|
6.3 units on a scale
Standard Deviation 7.1
|
5.4 units on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: baseline, 1 yearPopulation: Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Outcome measures
| Measure |
Duloxetine 40 mg
n=129 Participants
Duloxetine 40 mg once daily (QD), orally (PO), 1 year
|
Duloxetine 60 mg
n=128 Participants
Duloxetine 60 mg QD, PO, 1 year
|
|---|---|---|
|
Change From Baseline to One Year Endpoint in Beck Depression Inventory-II (BDI-II) Total Score
|
0.2 units on a scale
Standard Deviation 4.4
|
-0.7 units on a scale
Standard Deviation 3.7
|
Adverse Events
Duloxetine 40 mg
Serious events: 11 serious events
Other events: 126 other events
Deaths: 0 deaths
Duloxetine 60 mg
Serious events: 22 serious events
Other events: 121 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Duloxetine 40 mg
n=129 participants at risk
Duloxetine 40 mg once daily (QD), orally (PO), 1 year
|
Duloxetine 60 mg
n=129 participants at risk
Duloxetine 60 mg QD, PO, 1 year
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/129
|
1.6%
2/129 • Number of events 2
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Cardiac disorders
Myocardial ischaemia
|
0.78%
1/129 • Number of events 1
|
0.00%
0/129
|
|
Eye disorders
Glaucoma
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
General disorders
Generalised oedema
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Infections and infestations
Infected epidermal cyst
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Infections and infestations
Pyonephrosis
|
0.78%
1/129 • Number of events 1
|
0.00%
0/129
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.78%
1/129 • Number of events 1
|
0.00%
0/129
|
|
Injury, poisoning and procedural complications
Lung injury
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/129
|
1.6%
2/129 • Number of events 2
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vertebral injury
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.78%
1/129 • Number of events 1
|
0.00%
0/129
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.78%
1/129 • Number of events 1
|
0.00%
0/129
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/129
|
1.6%
2/129 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
1.6%
2/129 • Number of events 3
|
0.00%
0/129
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour embolism
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour invasion
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Nervous system disorders
Cerebral infarction
|
0.78%
1/129 • Number of events 1
|
0.00%
0/129
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.78%
1/129 • Number of events 1
|
0.00%
0/129
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cyst
|
0.78%
1/129 • Number of events 1
|
0.00%
0/129
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.78%
1/129 • Number of events 1
|
0.00%
0/129
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/129
|
0.78%
1/129 • Number of events 1
|
Other adverse events
| Measure |
Duloxetine 40 mg
n=129 participants at risk
Duloxetine 40 mg once daily (QD), orally (PO), 1 year
|
Duloxetine 60 mg
n=129 participants at risk
Duloxetine 60 mg QD, PO, 1 year
|
|---|---|---|
|
Eye disorders
Diabetic retinopathy
|
6.2%
8/129 • Number of events 8
|
2.3%
3/129 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
13.2%
17/129 • Number of events 19
|
13.2%
17/129 • Number of events 19
|
|
Gastrointestinal disorders
Diarrhoea
|
7.0%
9/129 • Number of events 10
|
5.4%
7/129 • Number of events 7
|
|
Gastrointestinal disorders
Nausea
|
10.9%
14/129 • Number of events 16
|
10.1%
13/129 • Number of events 15
|
|
Gastrointestinal disorders
Stomach discomfort
|
3.1%
4/129 • Number of events 7
|
5.4%
7/129 • Number of events 7
|
|
Gastrointestinal disorders
Vomiting
|
7.0%
9/129 • Number of events 11
|
7.8%
10/129 • Number of events 12
|
|
General disorders
Oedema peripheral
|
5.4%
7/129 • Number of events 9
|
6.2%
8/129 • Number of events 8
|
|
General disorders
Thirst
|
3.9%
5/129 • Number of events 5
|
6.2%
8/129 • Number of events 9
|
|
Infections and infestations
Nasopharyngitis
|
27.9%
36/129 • Number of events 52
|
24.0%
31/129 • Number of events 39
|
|
Infections and infestations
Pharyngitis
|
3.9%
5/129 • Number of events 6
|
8.5%
11/129 • Number of events 12
|
|
Injury, poisoning and procedural complications
Contusion
|
7.8%
10/129 • Number of events 11
|
9.3%
12/129 • Number of events 20
|
|
Investigations
Alanine aminotransferase increased
|
9.3%
12/129 • Number of events 12
|
10.1%
13/129 • Number of events 15
|
|
Investigations
Aspartate aminotransferase increased
|
10.1%
13/129 • Number of events 13
|
9.3%
12/129 • Number of events 14
|
|
Investigations
Blood alkaline phosphatase increased
|
4.7%
6/129 • Number of events 6
|
5.4%
7/129 • Number of events 8
|
|
Investigations
Blood creatine phosphokinase increased
|
9.3%
12/129 • Number of events 13
|
9.3%
12/129 • Number of events 12
|
|
Investigations
Blood creatinine increased
|
2.3%
3/129 • Number of events 4
|
6.2%
8/129 • Number of events 9
|
|
Investigations
Blood glucose decreased
|
10.9%
14/129 • Number of events 22
|
6.2%
8/129 • Number of events 9
|
|
Investigations
Blood glucose increased
|
10.9%
14/129 • Number of events 21
|
9.3%
12/129 • Number of events 14
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.4%
7/129 • Number of events 7
|
3.9%
5/129 • Number of events 5
|
|
Investigations
Blood potassium increased
|
5.4%
7/129 • Number of events 8
|
5.4%
7/129 • Number of events 10
|
|
Investigations
Blood triglycerides increased
|
7.0%
9/129 • Number of events 11
|
7.8%
10/129 • Number of events 10
|
|
Investigations
Blood urea increased
|
5.4%
7/129 • Number of events 7
|
3.1%
4/129 • Number of events 4
|
|
Investigations
Blood uric acid increased
|
4.7%
6/129 • Number of events 7
|
6.2%
8/129 • Number of events 8
|
|
Investigations
Blood urine present
|
3.1%
4/129 • Number of events 4
|
5.4%
7/129 • Number of events 8
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.8%
10/129 • Number of events 10
|
8.5%
11/129 • Number of events 11
|
|
Investigations
Glycosylated haemoglobin increased
|
24.0%
31/129 • Number of events 32
|
22.5%
29/129 • Number of events 29
|
|
Investigations
Urine albumin/creatinine ratio increased
|
7.8%
10/129 • Number of events 11
|
11.6%
15/129 • Number of events 15
|
|
Investigations
Weight increased
|
9.3%
12/129 • Number of events 13
|
8.5%
11/129 • Number of events 11
|
|
Investigations
White blood cell count increased
|
10.1%
13/129 • Number of events 16
|
6.2%
8/129 • Number of events 8
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
9.3%
12/129 • Number of events 13
|
8.5%
11/129 • Number of events 11
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
10.9%
14/129 • Number of events 34
|
8.5%
11/129 • Number of events 18
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.9%
5/129 • Number of events 5
|
7.0%
9/129 • Number of events 10
|
|
Nervous system disorders
Dizziness
|
7.8%
10/129 • Number of events 12
|
6.2%
8/129 • Number of events 11
|
|
Nervous system disorders
Headache
|
8.5%
11/129 • Number of events 31
|
7.0%
9/129 • Number of events 13
|
|
Nervous system disorders
Somnolence
|
13.2%
17/129 • Number of events 17
|
14.0%
18/129 • Number of events 18
|
|
Psychiatric disorders
Insomnia
|
8.5%
11/129 • Number of events 11
|
3.9%
5/129 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
7.0%
9/129 • Number of events 14
|
2.3%
3/129 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.2%
8/129 • Number of events 9
|
7.8%
10/129 • Number of events 14
|
|
Vascular disorders
Hypertension
|
7.0%
9/129 • Number of events 12
|
6.2%
8/129 • Number of events 8
|
|
Vascular disorders
Orthostatic hypotension
|
3.1%
4/129 • Number of events 4
|
6.2%
8/129 • Number of events 8
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60