A Study for the Treatment of Diabetic Peripheral Neuropathic Pain

Lilly

Status and phase: Completed; Phase 3

Conditions: Diabetic Neuropathies

Treatments: Drug: Duloxetine hydrochloride - 40 mg; Drug: Duloxetine hydrochloride - 60 mg; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00552175

12191

F1J-JE-HMFX (Other Identifier)

0715N0831 (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.

Enrollment: 339 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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339 participants in 3 patient groups, including a placebo group

Duloxetine 60

Experimental group

Description:

duloxetine 60 milligram (mg) taken orally every day

Treatment:

Drug: Duloxetine hydrochloride - 60 mg

Duloxetine 40

Experimental group

Description:

Duloxetine 40 mg taken orally every day

Treatment:

Drug: Duloxetine hydrochloride - 40 mg

Placebo

Placebo Comparator group

Description:

placebo comparator taken orally every day

Treatment:

Drug: placebo