Phase 4
N=407
An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic Pain
Diabetic Neuropathy, Painful
Bottom Line
View on ClinicalTrials.gov: NCT00385671 ↗Enrolled (actual)
407
Serious AEs
3.4%
Results posted
Oct 2010
Primary outcome: Primary: Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine — -2.12; -2.62 units on a scale — p=0.076
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- duloxetine hydrochloride (Drug); pregabalin (Drug); gabapentin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine |
-2.12; -2.62 | 0.076 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Duloxetine Compared With Duloxetine+Gabapentin |
-2.39; -2.62 | 0.417 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Weekly Mean of Nighttime Pain Severity |
-2.30; -2.71; -2.49 | 0.463 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Weekly Mean of the Daily Worst Pain Severity Score |
-2.59; -3.08; -2.86 | 0.389 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Clinical Global Impression of Severity Scale (CGI Severity) |
4.27; 4.47; 4.40; -1.06; -1.16; -1.13 | 0.602 |
| SECONDARY Patient's Global Impression of Improvement Scale (PGI - Improvement) at 12 Weeks |
3.03; 3.01; 2.83 | 0.276 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: 24-hour Average Pain |
5.53; 5.65; 5.75; -1.80; -2.44; -2.29 | 0.078 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Worst Pain |
6.73; 6.87; 7.00; -2.34; -3.02; -2.64 | 0.353 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Least Pain |
4.23; 4.18; 4.07; -1.27; -1.55; -1.54 | 0.298 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Pain Right Now |
4.98; 5.03; 5.36; -1.77; -2.24; -2.19 | 0.145 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference: With General Activity |
4.24; 5.03; 5.03; -1.51; -2.38; -1.86 | 0.263 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Mood |
3.42; 4.08; 4.10; -1.46; -1.85; -1.43 | 0.922 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Walking Ability |
5.25; 5.52; 5.79; -1.88; -2.56; -2.09 | 0.541 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Normal Work |
4.61; 4.98; 5.15; -1.63; -1.86; -1.88 | 0.451 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Relations With Other People |
2.96; 3.08; 3.29; -0.97; -1.27; -1.17 | 0.479 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Sleep |
4.91; 4.97; 5.40; -2.29; -2.12; -2.50 | 0.528 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Enjoyment of Life |
4.38; 4.63; 5.02; -1.82; -2.09; -2.33 | 0.098 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Mean Interference Score |
4.25; 4.61; 4.83; -1.62; -2.00; -1.90 | 0.309 |
| SECONDARY Number of Participants With ≥ 30% Reduction in the Weekly Mean 24 Hour Average Pain Score at 12 Weeks |
65; 68; 72 | 0.975 |
| SECONDARY Number of Patients With a Reduction of ≥ 50% in Weekly Mean of 24 Hour Average Pain Score |
48; 50; 47 | 0.548 |
| SECONDARY Number of Participants With a ≥ 2-points Reduction on the Weekly Average of the Daily 24-hour Average Pain Scale at 12 Weeks |
59; 64; 68 | 0.905 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS) |
10.96; 17.40; 14.75; 9.32; 7.39; 9.64 | 0.572 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3 |
-4.96; -3.47; -4.54; -1.96; -1.21; -1.95 | 0.635 |
| SECONDARY Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation |
0; 4; 4; 5; 0; 0 | — |
| SECONDARY Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores |
-0.53; 0.48; 1.29; -0.01; 1.12; -0.61 | 0.096 |
| SECONDARY Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores |
24; 26; 31; 9; 9; 11 | 0.486 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores |
-6.27; -8.92; -7.29; -5.12; -6.23; -5.29 | 0.645 |
| SECONDARY Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores |
68; 84; 86; 8; 5; 4 | 0.130 |
| SECONDARY Path Analysis of Improvement in Pain Through Improvement in Depressive Symptoms |
-0.449; 0.014; -0.435 | 0.107 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Beck Depression Inventory II (BDI-II) Total Score |
-2.57; -3.13; -2.54 | 0.968 |
| SECONDARY Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale |
10; 12; 13; 65; 66; 59 | — |
| SECONDARY Summary of Number of Participants Who Discontinued |
38; 51; 36 | — |
| SECONDARY Time to First ≥ 30% Reduction in Weekly Mean 24 Hour Average Pain Score |
35.0; 28.0; 28.0 | 0.103 |
| SECONDARY Time to First ≥ 50 % Reduction in Weekly Mean 24 Hour Average Pain Score |
— | — |
| SECONDARY Time to First Sustained Response in Weekly Mean 24 Hour Average Pain Score |
— | — |
| SECONDARY Time to First ≥ 2 Points Reduction in Weekly Mean 24 Hour Average Pain Score |
56.0; 35.0; 28.0 | 0.008 sig |
| SECONDARY Weekly Mean Change in 24 Hour Average Pain Severity +/- Generalized Anxiety Disorder (GAD) |
— | — |
| SECONDARY Weekly Mean Change From Baseline to 12 Weeks in 24 Hour Average Pain Severity - Only Participants Who Adhered to Key Protocol Requirements (Per-Protocol Population) |
5.74; 6.02; 5.74; -2.12; -2.58; -2.40 | 0.365 |
| SECONDARY Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use) |
5.24; 5.39; 5.49; -0.22; -0.71; -0.38 | 0.622 |
| SECONDARY Discontinuations for Abnormal Laboratory Analytes, Vital Signs, Overall and for Each Measure |
0; 0; 1; 1; 0; 0 | — |
| SECONDARY Mean Change From Baseline to 12 Weeks in Blood Pressure |
0.18; 2.24; -0.79; -3.31; -3.08; -2.08 | 0.448 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Heart Rate |
-1.30; 0.80; 1.05 | 0.078 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Body Weight |
1.00; -2.39; -1.06 | <0.001 sig |
| SECONDARY Number of Participants With Treatment-emergent Elevated Blood Pressure |
11; 12; 13; 20; 15; 16 | 0.830 |
| SECONDARY Number of Participants With Treatment-Emergent Elevated Heart Rate |
2; 9; 6 | 0.281 |
| SECONDARY Number of Participants With Treatment-Emergent Changes in Body Weight |
6; 1; 3; 2; 10; 8 | 0.332 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels |
22.55; 22.84; 23.42; 1.12; -0.52; -0.48 | 0.055 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Total Bilirubin |
8.43; 8.07; 8.23; -0.51; -0.28; -0.42 | 0.285 |
| SECONDARY Mean Change From Baseline to 12 Weeks in Fasting Plasma Glucose |
8.24; 8.45; 7.99; 0.16; 0.19; 0.67 | 0.047 sig |
| SECONDARY Mean Change From Baseline to 12 Weeks in Hemoglobin A1C |
7.57; 7.51; 7.16; -0.12; -0.01; 0.07 | 0.298 |
| SECONDARY Number of Patients With Treatment-Emergent Elevated Laboratory Analytes |
4; 6; 4; 3; 6; 10 | 1.00 |
Summary
To test the non-inferiority of duloxetine monotherapy as a treatment for the management of diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who have not had an adequate response to gabapentin.
Eligibility Criteria
Inclusion Criteria
- You must have been diagnosed with Diabetic Neuropathic Pain
- Patient has an average daily pain score greater than or equal to 4 on an 11-point Likert scale, and patient or provider feel that a change from the current gabapentin therapy for pain management is warranted
- Patient is currently treated with gabapentin greater than or equal to 900 milligram/day, has been prescribed the current dose for at least 4 weeks, and has been at least 80% compliant with dosing, according to patient report
- Patient must agree not to change dose of gabapentin between Visits 1 and 2
- You must have stable glycemic control
Exclusion Criteria
- Are judged prior to randomization to be at suicidal risk as defined by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II)
- Current diagnosis or history of hemangiosarcoma
- Patients with New York Heart Association Class III or IV symptoms of congestive heart failure
- Patients with uncontrolled narrow-angle glaucoma
- Presence of a current seizure disorder
Data sourced from ClinicalTrials.gov (NCT00385671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.