Phase 3
N=339
A Study for the Treatment of Diabetic Peripheral Neuropathic Pain
Diabetic Neuropathies
Bottom Line
View on ClinicalTrials.gov: NCT00552175 ↗Enrolled (actual)
339
Serious AEs
3.3%
Results posted
Apr 2010
Primary outcome: Primary: Change From Baseline at Week 12 in Average Pain Severity Rating Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg) — -1.61; -2.47 units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Duloxetine hydrochloride - 40 mg (Drug); placebo (Drug); Duloxetine hydrochloride - 60 mg (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline at Week 12 in Average Pain Severity Rating Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg) |
-1.61; -2.47 | <0.0001 sig |
| SECONDARY Change From Baseline at Week 12 in Average Pain Severity Rating Score Using Diaries |
-1.61; -2.41; -2.53 | — |
| SECONDARY Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg) |
-1.55; -2.51; -1.56; -2.39 | <0.0001 sig |
| SECONDARY Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries |
-1.55; -2.42; -2.59; -1.56; -2.33; -2.45 | — |
| SECONDARY Patient Global Impression of Improvement Scale at Week 12 in Combined Duloxetine Arms (40 mg + 60 mg) |
3.18; 2.53 | <0.0001 sig |
| SECONDARY Patient Global Impression of Improvement Scale at Week 12 |
3.18; 2.53; 2.52 | — |
| SECONDARY Change From Baseline in Brief Pain Inventory Severity Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg) |
-1.62; -2.59; -1.13; -1.98; -1.54; -2.54 | <0.0001 sig |
| SECONDARY Change From Baseline in Brief Pain Inventory Severity Scores at Week 12 |
-1.62; -2.51; -2.68; -1.13; -1.92; -2.04 | — |
| SECONDARY Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg) |
-1.88; -2.29; -1.91; -2.28; -1.82; -2.31 | 0.0676 |
| SECONDARY Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 |
-1.88; -2.48; -2.1; -1.91; -2.18; -2.39 | — |
| SECONDARY Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg) |
-3.27; -3.37 | 0.8517 |
| SECONDARY Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12 |
-3.28; -2.94; -3.83 | — |
Summary
The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.
Eligibility Criteria
Inclusion Criteria
- Patients with pain due to bilateral peripheral neuropathy induced by type 1 or 2 diabetes mellitus. The pain must have been present for at least 6 months and be evaluable in feet, legs, or hands.
- Participants with hemoglobin A1c (HbA1c) less than or equal to 9.0 percent at Visit 1.
- Participants in whom HbA1c had been measured 42-70 days before Visit 1 and subsequent HbA1c levels have been within +/- 1.0 percent of the level at Visit 1.
- Participants with a mean of the 24-hour average pain severity scores (round off to a whole number) of 4 or higher, as calculated from the patient diary for 7 days immediately before Visit 2
Exclusion Criteria
- Participants who have undergone renal transplant or who are currently on renal dialysis.
- Participants who have a history requiring pharmacotherapy within the past year or current history of psychiatric disease, such as mania, bipolar disorder, depression, anxiety disorder, or eating disorder.
- Participants with hypertension with poor control of blood pressure (systolic blood pressure greater than or equal to 180 millimeters of mercury (mmHg) or diastolic blood pressure greater than or equal to 110 mmHg
- Participants with alanine transaminase (ALT) or aspartate transaminase (AST) greater than or equal to 100 Units per Liter (U/L) at Visit 1.
- Participants unable to discontinue prohibited concomitant drugs or concomitant therapies after Visit 1.
Data sourced from ClinicalTrials.gov (NCT00552175). 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.