Phase 3 N=215 Randomized Quadruple-blind Treatment

Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China

Diabetic Neuropathies

Bottom Line

View on ClinicalTrials.gov: NCT00408993 ↗

Enrolled (actual)

215

Serious AEs

—

Results posted

Jun 2009

Primary outcome: Primary: Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score — -2.69; -2.31 units on a scale — p=0.617

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Duloxetine Hydrochloride (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score	-2.69; -2.31	0.617
SECONDARY Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores	-3.48; -2.93; -1.69; -1.37; -2.72; -1.99	0.070
SECONDARY Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity	-1.24; -0.99	0.036 sig
SECONDARY Time Course of Change in Patient Global Impression - Improvement Scale	3.45; 3.51; 2.91; 3.23; 2.57; 2.83	0.955
SECONDARY Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) (US Based Index Score)	0.12; 0.10	0.207
SECONDARY Number of Participants Discontinuing Due to Adverse Events	15; 4	0.008 sig
SECONDARY Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)	3; 1; 2; 4; 7; 2	—
SECONDARY Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item	-2.27; -1.97; -3.58; -3.31	0.364
SECONDARY Vital Signs - Weight	-0.17; -0.03	0.620
SECONDARY Vital Signs - Pulse Rate	1.71; 0.32	0.324
SECONDARY Vital Signs - Blood Pressure	-0.48; -1.47; 0.45; -0.21	0.642
SECONDARY Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides	102.94; 102.87; -1.15; -0.20; 1.30; 1.33	0.014 sig
SECONDARY Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid	293.24; 283.98; -7.46; 2.49	0.017 sig

Summary

To determine if duloxetine 60mg up to 120mg daily can work in treating pain from Diabetic Neuropathy.

Eligibility Criteria

Inclusion Criteria

Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes with the pain beginning in the feet and present for at least 6 months.
May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study.
Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item.

Exclusion Criteria

Glycosylated hemoglobin (A1C) > 12%
Severe hepatic disease
History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or severe cirrhosis), kidney, respiratory, blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or likely to lead to hospitalization during the course of the study.
Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the potential need to take during or within 5 days after discontinuation from the study.
Treatment of fluoxetine within 30 days of starting the study.
Unstable blood sugar control and uncontrolled or poorly controlled hypertension.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00408993). 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.