Diabetic NeuropathiesPhase 3NCT00641719

A Long-term Study for the Treatment of Painful Diabetic Neuropathy

A Phase 3 study testing Duloxetine hydrochloride in people with Diabetic Neuropathies, run by Eli Lilly and Company at 25 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to investigate safety and efficacy of duloxetine for patients with painful diabetic neuropathy at long-term use. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Diabetic Neuropathies
What is being tested?: Duloxetine hydrochloride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 258 participants
Where: 25 sitesJapan
Study dates: Mar 2008to Mar 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Outpatients who have completed the 13-week treatment in the preceding study (Protocol No. 0715N0831: NCT00552175).
Patients who desire to receive continued treatment with LY248686 from the preceding study.
Patients with latest glycosylated hemoglobin (HbA1c) ≤9.0% before Visit 7.
Patients who can provide written consent in person.

Who cannot join

Patients who concurrently have serious cardiovascular, hepatic, renal, respiratory, or blood disease, or symptomatic peripheral vascular disease, and thus are considered inappropriate to be included in the study.
Pregnant patients or women who desire to become pregnant during the study period, and breast feeding patients.
Other patients judged by the investigator/subinvestigator to be inappropriate as a subject in this study.

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

Japan25 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aichi
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Aomori
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Chiba
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Fukui
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Fukuoka
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Fukushima
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Gunma
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Hiroshima
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Hokkaido
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Hyōgo
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Ibaraki
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Kagoshima
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Kanagawa
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Kyoto
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Miyagi
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Niigata
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Ōita
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Okayama
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Osaka
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Saitama
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Shizuoka
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Tochigi
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tokushima
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tokyo
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Toyama

Other trials in Japan

About this study

Official title: A Superiority Study of LY248686 Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain - Extension Phase

The purpose of the study is to investigate safety and efficacy of duloxetine for patients with painful diabetic neuropathy at long-term use.

Conditions: Diabetic Neuropathies
Being tested: Duloxetine hydrochloride
Medical subject headings: Diabetic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Duloxetine hydrochlorideDrug
Also called LY248686, Cymbalta
Duloxetine 40 mg QD, PO, 1 year
Duloxetine hydrochlorideDrug
Also called LY248686, Cymbalta
Duloxetine 60 mg QD, PO, 1 year

Study groups in NCT00641719
Study group	Role	What they receive
Duloxetine 40 mg	Experimental	Duloxetine 40 milligrams (mg) once daily (QD), orally (PO), 1 year Receives: Drug: Duloxetine hydrochloride
Duloxetine 60 mg	Experimental	Duloxetine 60 mg QD, PO, 1 year Receives: Drug: Duloxetine hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Experienced an Adverse Event (AE)
See the Reported Adverse Events section for details.
Measured: baseline through 1 year

Secondary outcomes (8)

Patient Global Impression of Improvement (PGI-I) Scale at One Year Endpoint.
A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Measured: 1 year
Change From Baseline to One Year Endpoint for Patient Global Impression of Improvement (PGI-I) Scale
A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Measured: baseline, 1 year
Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint
A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now.
Measured: 1 year
Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores
A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now.
Measured: baseline, 1 year
Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint
Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes).
Measured: 1 year
Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores
Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes).
Measured: baseline, 1 year
Beck Depression Inventory-II (BDI-II) Total Score at One Year Endpoint
A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Measured: 1 year
Change From Baseline to One Year Endpoint in Beck Depression Inventory-II (BDI-II) Total Score
A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Measured: baseline, 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Mar 2010

First posted24 Mar 2008 (estimated)
Study startMar 2008
Primary completionMar 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 258 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00641719
Sponsor's protocol ID: 12194
Other IDs: F1J-JE-HMFY
Status last verified: Mar 2011
First submitted: 19 Mar 2008
Last updated: 31 Mar 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Yasuda H, Hotta N, Kasuga M, Kashiwagi A, Kawamori R, Yamada T, Baba Y, Alev L, Nakajo K. Efficacy and safety of 40 mg or 60 mg duloxetine in Japanese adults with diabetic neuropathic pain: Results from a randomized, 52-week, open-label study. J Diabetes Investig. 2016 Jan;7(1):100-8. doi: 10.1111/jdi.12361. Epub 2015 May 18.
PubMed 26816607

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
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All Diabetic Neuropathies trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Superiority Study of LY248686 Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain - Extension Phase
ClinicalTrials.gov ID: NCT00641719
Acronym / sponsor ID: 12194
Conditions: Diabetic Neuropathies
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 258 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Shionogi
Study start: Mar 2008
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 24 Mar 2008 (estimated)
Results: Posted 31 Mar 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to investigate safety and efficacy of duloxetine for patients with painful diabetic neuropathy at long-term use.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Duloxetine 40 mg	Experimental	Drug: Duloxetine hydrochlorideDuloxetine 40 milligrams (mg) once daily (QD), orally (PO), 1 year
Duloxetine 60 mg	Experimental	Drug: Duloxetine hydrochlorideDuloxetine 60 mg QD, PO, 1 year

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Outpatients who have completed the 13-week treatment in the preceding study (Protocol No. 0715N0831: NCT00552175).
Patients who desire to receive continued treatment with LY248686 from the preceding study.
Patients with latest glycosylated hemoglobin (HbA1c) ≤9.0% before Visit 7.
Patients who can provide written consent in person.

Key exclusion criteria (3 listed)

Patients who concurrently have serious cardiovascular, hepatic, renal, respiratory, or blood disease, or symptomatic peripheral vascular disease, and thus are considered inappropriate to be included in the study.
Pregnant patients or women who desire to become pregnant during the study period, and breast feeding patients.
Other patients judged by the investigator/subinvestigator to be inappropriate as a subject in this study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Duloxetine hydrochlorideAlso: LY248686, CymbaltaDuloxetine 40 mg QD, PO, 1 year	Drug	Duloxetine 40 mg
Duloxetine hydrochlorideAlso: LY248686, CymbaltaDuloxetine 60 mg QD, PO, 1 year	Drug	Duloxetine 60 mg

Primary outcome

Number of Participants Who Experienced an Adverse Event (AE)
Time frame: baseline through 1 year
See the Reported Adverse Events section for details.

8 secondary outcomes

Patient Global Impression of Improvement (PGI-I) Scale at One Year Endpoint.
Time frame: 1 year
Change From Baseline to One Year Endpoint for Patient Global Impression of Improvement (PGI-I) Scale
Time frame: baseline, 1 year
Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint
Time frame: 1 year
Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores
Time frame: baseline, 1 year
Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint
Time frame: 1 year
Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores
Time frame: baseline, 1 year
Beck Depression Inventory-II (BDI-II) Total Score at One Year Endpoint
Time frame: 1 year
Change From Baseline to One Year Endpoint in Beck Depression Inventory-II (BDI-II) Total Score
Time frame: baseline, 1 year

Results and safety

Results posted to the registry on 31 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Duloxetine 40 mg	129	99
Duloxetine 60 mg	129	92

Primary outcome: Number of Participants Who Experienced an Adverse Event (AE)

Time frame: baseline through 1 year. Number. Unit: participants

Measure	Duloxetine 40 mg n = 129	Duloxetine 60 mg n = 129
Serious Adverse Events	11	22
Adverse Events	126	121

Population analysed: All participants who received at least 1 dose of study drug.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Duloxetine 40 mg	11 of 129 (8.5%)	126 of 129 (97.7%)	Not reported
Duloxetine 60 mg	22 of 129 (17.1%)	121 of 129 (93.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26816607Yasuda H, Hotta N, Kasuga M, Kashiwagi A, Kawamori R, Yamada T, Baba Y, Alev L, Nakajo K. Efficacy and safety of 40 mg or 60 mg duloxetine in Japanese adults with diabetic neuropathic pain: Results from a randomized, 52-week, open-label study. J Diabetes Investig. 2016 Jan;7(1):100-8. doi: 10.1111/jdi.12361. Epub 2015 May 18.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Diabetic Neuropathies

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

Eli Lilly and Company

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Duloxetine hydrochloride in people with Diabetic Neuropathies, run by Eli Lilly and Company at 25 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experienced an Adverse Event (AE) (time frame: baseline through 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00641719, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2011.