A Study in Painful Diabetic Neuropathy

NCT ID: NCT01089556

Last Updated: 2013-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 811 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-11-30

Brief Summary

This study will investigate the efficacy of a combination treatment of duloxetine + pregabalin compared with the maximal dose of each drug in monotherapy, in patients with diabetic peripheral neuropathic pain (DPNP) who have not responded to the standard recommended dose of either drug. It will provide an answer to a common clinical question, namely, is it better to increase the dose of the current monotherapy or to combine both treatments early on, in patients who do not respond to standard doses of duloxetine or pregabalin.

Conditions

Diabetic Neuropathy, Painful

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Duloxetine

Initial Treatment:

Duloxetine 30 milligram (mg) daily for 1 week

Duloxetine 60 mg daily for 7 weeks

Intensive Treatment:

Duloxetine 90 mg (60 mg in the morning, 30 mg in the evening) daily for 1 week

Duloxetine 120 mg (60 mg twice daily) daily for 7 weeks

Group Type: EXPERIMENTAL

Duloxetine

Intervention Type: DRUG

Administered orally

Placebo

Intervention Type: DRUG

Administered orally, daily as a blind for duloxetine and/or pregabalin for 8 or 16 weeks

Pregabalin+Duloxetine

Initial Treatment:

Pregabalin 150 mg daily for 1 week

Pregabalin 300 mg (150 mg twice daily) daily for 7 weeks

Intensive Treatment:

Pregabalin 300 mg (150 mg twice daily) daily for 8 weeks

Duloxetine 30 mg daily for 1 week

Duloxetine 60 mg daily for 7 weeks

Group Type: EXPERIMENTAL

Duloxetine

Intervention Type: DRUG

Administered orally

Pregabalin

Intervention Type: DRUG

Administered orally

Placebo

Intervention Type: DRUG

Administered orally, daily as a blind for duloxetine and/or pregabalin for 8 or 16 weeks

Pregabalin

Initial Treatment:

Pregabalin 150 mg daily for 1 week

Pregabalin 300 mg (150 mg twice daily) daily for 7 weeks

Intensive Treatment:

Pregabalin 450 mg (300 mg in the morning, 150 mg in the evening) daily for 1 week

Pregabalin 600 mg (300 mg twice daily) daily for 7 weeks

Group Type: EXPERIMENTAL

Pregabalin

Intervention Type: DRUG

Administered orally

Placebo

Intervention Type: DRUG

Administered orally, daily as a blind for duloxetine and/or pregabalin for 8 or 16 weeks

Duloxetine + Pregabalin

Initial Treatment:

Duloxetine 30 mg daily for 1 week

Duloxetine 60 mg daily for 7 weeks

Intensive Treatment:

Duloxetine 60 mg daily for 8 weeks

Pregabalin 150 mg daily for 1 week

Pregabalin 300 mg (150 mg twice daily) daily for 7 weeks

Group Type: EXPERIMENTAL

Duloxetine

Intervention Type: DRUG

Administered orally

Pregabalin

Intervention Type: DRUG

Administered orally

Placebo

Intervention Type: DRUG

Administered orally, daily as a blind for duloxetine and/or pregabalin for 8 or 16 weeks

Interventions

Duloxetine

Administered orally

Intervention Type: DRUG

Pregabalin

Administered orally

Intervention Type: DRUG

Placebo

Administered orally, daily as a blind for duloxetine and/or pregabalin for 8 or 16 weeks

Intervention Type: DRUG

Other Intervention Names

Cymbalta; LY248686

Eligibility Criteria

Inclusion Criteria

• Pain due to bilateral peripheral neuropathy (caused by type 1 or type 2 diabetes mellitus. Pain must begin in the feet, with relatively symmetrical onset. Daily pain should be present for more than 3 months [assessed by questioning patient]).
• Score of at least 4 on the 24-hour average pain severity score on an 11-point Likert scale [on Brief Pain Inventory (BPI) Modified Short Form] at screening and at randomization.
• Patient is currently not receiving treatment for diabetic peripheral neuropathic pain (DPNP) or was receiving treatment for DPNP, with a drug other than pregabalin or duloxetine, and completed the required washout
• Patient has never received treatment with duloxetine or pregabalin. (However, a short course of less than 15 days of treatment, at any time previously, will be allowed.)
• Stable glycemic control, as assessed by a physician investigator, and hemoglobin A1c (HbA1c) less than or equal to 12% at screening.

Exclusion Criteria

• Have a known hypersensitivity to duloxetine or pregabalin or any of the inactive ingredients or have any contraindication for the use of duloxetine or pregabalin.
• Have uncontrolled narrow-angle glaucoma.
• Have received treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to randomization, or have a potential need to use a MAOI during the study or within 5 days after discontinuation of study drug.
• Have received fluoxetine within 30 days prior to randomization.
• Have acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C).
• Have a serum creatinine greater than or equal to 1.5 milligram per deciliter (mg/dL) or a creatinine clearance less than 60 milliliter per minute (mL/min), at screening.
• Are judged clinically by the investigator to be at suicidal risk or as defined by a score of 2 or greater on Question 9 of the Beck Depression Inventory-II (BDI-II), at screening or randomization
• Have a historical exposure to drugs known to cause neuropathy (for example, vincristine), or a history of a medical condition, including pernicious anemia and hypothyroidism, that could have been responsible for neuropathy.
• Have pain that cannot be clearly differentiated from or conditions that interfere with the assessment of the DPNP.
• Have serious or unstable cardiovascular, hepatic, renal, respiratory or hematological illness; symptomatic peripheral vascular disease; a history of seizure disorder; or other medical (including unstable hypertension and not clinically euthyroid) or psychological conditions that, in the opinion of the investigator, would compromise participation or be likely to require hospitalization during the course of the study.
• Have received non-pharmacological treatment for pain within 14 days prior to randomization, or do not agree to abstain from non-pharmacological treatment during the study.
• Have a history of frequent and/or severe allergic reactions with multiple medications.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5AM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Newcastle, New South Wales, Australia

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Warrawong, New South Wales, Australia

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Elizabeth Vale, South Australia, Australia

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Kelowna, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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Cambridge, Ontario, Canada

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Laval, Quebec, Canada

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Osijek, , Croatia

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Rijeka, , Croatia

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Varaždin, , Croatia

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Zagreb, , Croatia

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Angers, , France

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Antibes Juan Les Pins, , France

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Bourges, , France

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Nevers, , France

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Nîmes, , France

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Paris, , France

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Valenciennes, , France

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Vierzon, , France

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Vieux-Condé, , France

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Dresden, , Germany

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Schkeuditz, , Germany

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Ampelokipoi, , Greece

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Athens, , Greece

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Melíssia, , Greece

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Catania, , Italy

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Milan, , Italy

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Napoli, , Italy

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Rome, , Italy

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Mexico City, , Mexico

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Eindhoven, , Netherlands

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Maastricht, , Netherlands

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Bialystok, , Poland

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Lublin, , Poland

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Szczecin, , Poland

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Wroclaw, , Poland

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Seoul, , South Korea

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Girona, , Spain

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Valencia, , Spain

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Falköping, , Sweden

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Huddinge, , Sweden

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Lund, , Sweden

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Stockholm, , Sweden

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Zurich, , Switzerland

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Ankara, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Ashton-under-Lyne, Ashton-Under-Lyne, United Kingdom

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Chorley, Chorley, United Kingdom

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Manchester, Greater Manchester, United Kingdom

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Ayrshire, Scotland, United Kingdom

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Nuneaton, Warwickshire, United Kingdom

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Livingston, West Lothian, United Kingdom

Countries

Australia; Canada; Croatia; France; Germany; Greece; Italy; Mexico; Netherlands; Poland; South Korea; Spain; Sweden; Switzerland; Turkey (Türkiye); United Kingdom

Other Identifiers

F1J-EW-HMGQ

Identifier Type: OTHER

Identifier Source: secondary_id

13084

Identifier Type: -

Identifier Source: org_study_id