Conditions

Outcome Measures

Change From Baseline at Week 12 in Average Pain Severity Rating Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)
Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Baseline, 12 weeks

Change From Baseline at Week 12 in Average Pain Severity Rating Score Using Diaries
Baseline, 12 weeks
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)
Baseline, 12 weeks
Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries
Baseline, Week 12
Patient Global Impression of Improvement Scale at Week 12 in Combined Duloxetine Arms (40 mg + 60 mg)
Week 12
Patient Global Impression of Improvement Scale at Week 12
Week 12
+6 more secondary outcomes

EXPERIMENTAL

duloxetine 60 milligram (mg) taken orally every day

Drug: Duloxetine hydrochloride - 60 mg

EXPERIMENTAL

Duloxetine 40 mg taken orally every day

Drug: Duloxetine hydrochloride - 40 mg

PLACEBO COMPARATOR

placebo comparator taken orally every day

Drug: placebo

duloxetine 40 mg taken orally every day

Also known as: LY248686, Cymbalta

Duloxetine 40

placebo taken orally every day

Placebo

duloxetine 60 mg taken orally every day

Also known as: LY248686, Cymbalta

Duloxetine 60

Age20 Years - 79 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

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.

Contact the study team to confirm eligibility.