Phase
Condition
Pain
Diabetic Neuropathy
Pain (Pediatric)
Treatment
LY3556050
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have a history and current diagnosis of Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D) diagnosed for at least 6 months prior to screening.
Have a stable glycemic control on stable diabetes treatment regimen for at least 90days prior to day 1 with a hemoglobin A1c (HbA1c) ≤10 for T1D and HbA1c ≤11 forparticipants with T2D at time of screening.
Have a history of daily peripheral neuropathic pain for at least 12 weeks based onparticipant report or medical history.
Have a visual analog scale (VAS) pain value ≥40 and <95 during screening.
Have presence of diabetic peripheral neuropathy of symmetrical nature and in lowerextremities for ≥6 months and diagnosed by a score of Part B ≥3 on MichiganNeuropathy Screening Instrument
Are willing to maintain a consistent regimen of any ongoing nonpharmacologicpain-relieving therapies (for example, physical therapy) and will not start any newnonpharmacologic pain-relieving therapies during study participation.
Are willing to discontinue all medications taken for chronic pain conditions, exceptallowed concomitant pain medication permitted per protocol, for the duration of thestudy
Have a body mass index ≤45 kilogram/square meter (kg/m²) (inclusive).
Are men, or women able to abide by reproductive and contraceptive requirements.
Exclusion
Exclusion Criteria:
History of other potentially causative and/or confounding sources of pain that mayimpair self-assessment of pain due to DPNP.
Have had a procedure within the past 6 months intended to produce permanent sensoryloss in the target area of interest (for example, ablation techniques.
Have had cancer within 2 years of baseline, except for cutaneous basal cell orsquamous cell carcinoma resolved by excision.
Are, in the judgment of the investigator, actively suicidal and therefore deemed tobe at significant risk for suicide.
Have in the judgement of the investigator, an acute, serious, or unstable medicalcondition or a history or presence of any other medical illness that would precludestudy participation.
Have a positive HIV test result at screening.
Have a surgery planned during the study for any reason.
Have a substance use disorder as defined by the Diagnostic and Statistical Manual ofMental Disorders (5th edition; DSM-5; American Psychiatric Association)
Study Design
Connect with a study center
EDUMED - Broumov
Broumov, Královéhradecký Kraj 550 01
CzechiaActive - Recruiting
Diabet2 s.r.o., diabetologicka a interni ambulance
Praha, Praha 1 11000
CzechiaActive - Recruiting
DiaVize s.r.o.
Praha, Praha 4 140 00
CzechiaSite Not Available
Neurologická Ambulance - Forbeli
Praha, Praha 6 160 00
CzechiaActive - Recruiting
FLEDIP - Na dlouhem lanu
Prague, Praha, Hlavní Mešto 160 00
CzechiaActive - Recruiting
FLEDIP s.r.o.
Prague, Praha, Hlavní Mešto 160 00
CzechiaActive - Recruiting
DiaVize s.r.o.
Praha 4, Praha, Hlavní Mešto 140 00
CzechiaActive - Recruiting
Vestra Clinics
European Union, Rychnov Nad Kněžnou 516 01
CzechiaActive - Recruiting
Agentura Science Pro
Olomouc, 779 00
CzechiaActive - Recruiting
Matsuyama Shimin Hospital
Matsuyama, Ehime 790-0067
JapanActive - Recruiting
Kikuchi Naika Clinic
Maebashi, Gunma 370-3573
JapanActive - Recruiting
Kure Medical Center
Kure, Hiroshima 737-0023
JapanActive - Recruiting
Japanese Red Cross Asahikawa Hospital
Asahikawa, Hokkaido 070-8530
JapanActive - Recruiting
Yokohama Minoru Clinic
Yokohama, Kanagawa 232-0064
JapanActive - Recruiting
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka 565-0853
JapanActive - Recruiting
Sugiura Internal Medicine Clinic
Soka, Saitama 340-0034
JapanSite Not Available
Sugiura Internal Medicine Clinic
Sokashi, Saitama 340-0015
JapanActive - Recruiting
Suruga Clinic
Shizuoka-city, Shizuoka 424-0855
JapanActive - Recruiting
Medical Corporation Sato Medical clinic
Ootaku, Tokyo 143-0015
JapanActive - Recruiting
Heishinkai Medical Group ToCROM Clinic
Shinjuku-ku, Tokyo 160-0008
JapanActive - Recruiting
Medical Corporation Sato Medical clinic
Ōtake, Tokyo 143-0015
JapanSite Not Available
Kunisaki Makoto Clinic
Fukuoka, 819-0168
JapanActive - Recruiting
Minamiosaka Hospital
Osaka, 559-0012
JapanActive - Recruiting
Plumeria DM Clinic
Shizuoka, 422-8006
JapanActive - Recruiting
Jeonbuk National University Hospital
Jeonju, Jeonrabugdo 54907
Korea, Republic ofSite Not Available
Jeonbuk National University Hospital
Jeonju-si, Jeonrabugdo 54907
Korea, Republic ofActive - Recruiting
Kangwon National University Hospital
Chuncheon-si, Kang-won-do 24289
Korea, Republic ofSite Not Available
Sejong General Hospital
Sosa, Kyǒnggi-do 14754
Korea, Republic ofSite Not Available
Sejong General Hospital
Sosa-gu, Kyǒnggi-do 14754
Korea, Republic ofActive - Recruiting
Konkuk University Medical Center
Seoul, Seoul-teukbyeolsi [Seoul] 05030
Korea, Republic ofActive - Recruiting
Nowon Eulji Medical Center, Eulji University
Seoul, Seoul-teukbyeolsi [Seoul] 01830
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul] 06351
Korea, Republic ofActive - Recruiting
Eulji University Hospital
Daejeon, Taejǒn-Kwangyǒkshi 01830
Korea, Republic ofActive - Recruiting
Centrum Badań Klinicznych Piotr Napora lekarze sp.p.
Wroclaw, Dolnośląskie 51-162
PolandActive - Recruiting
MICS Centrum Medyczne Torun
Torun, Kujawsko-pomorskie 87-100
PolandActive - Recruiting
MICS Centrum Medyczne Warszawa
Warszawa, Mazowieckie 00-874
PolandActive - Recruiting
Medycyna Kliniczna
Warszawa, Mazowieckie 00-874
PolandActive - Recruiting
Samodzielny Publiczny Zespol Opieki Zdrowotnej w Wyszkow
Wyszkow, Mazowieckie 07-200
PolandActive - Recruiting
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
Krakow, Małopolskie 31-261
PolandActive - Recruiting
NZOZ Diab-Endo-Met
Krakow, Małopolskie 31-261
PolandActive - Recruiting
Osteo Medic sc A. Racewicz, J. Supronik
Biaystok, Podlaskie 15-351
PolandActive - Recruiting
Zdrowie Osteo-Medic
Biaystok, Podlaskie 15-351
PolandActive - Recruiting
Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
Poznan, Wielkopolskie 61-853
PolandActive - Recruiting
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, Łódzkie 90-338
PolandActive - Recruiting
Centrum Medyczne Pratia Katowice
Katowice, Śląskie 40-081
PolandActive - Recruiting
Pro Familia Altera
Katowice, Śląskie 40-648
PolandActive - Recruiting
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
Ruda Slaska, Śląskie 41-709
PolandActive - Recruiting
Samodzielny Publiczny Szpital Kliniczny nr 1 SUM
Zabrze, Śląskie 41-800
PolandSite Not Available
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Chandler, Arizona 85225
United StatesActive - Recruiting
The Institute for Liver Health dba Arizona Clinical Trials
Chandler, Arizona 85225
United StatesActive - Recruiting
The Institute for Liver Health dba Arizona Clinical Trials
Mesa, Arizona 85210
United StatesSite Not Available
Headlands Research - Scottsdale
Scottsdale, Arizona 85260
United StatesActive - Recruiting
Orange Grove Family Practice
Tucson, Arizona 85741
United StatesActive - Recruiting
Synexus Clinical Research US, Inc.//Orange Grove Family Practice
Tucson, Arizona 85741
United StatesActive - Recruiting
Preferred Research Partners
Little Rock, Arkansas 72211
United StatesActive - Recruiting
Hope Clinical Research, Inc.
Canoga Park, California 91303
United StatesActive - Recruiting
Valley Clinical Trials, Inc.
Northridge, California 91325
United StatesActive - Recruiting
Northern California Research - Sacramento
Sacramento, California 95821
United StatesActive - Recruiting
CMR of Greater New Haven, LLC
Hamden, Connecticut 06517
United StatesActive - Recruiting
New Horizon Research Center
Miami, Florida 33165
United StatesActive - Recruiting
Suncoast Research Group
Miami, Florida 33135
United StatesActive - Recruiting
Northwestern University
Chicago, Illinois 60611
United StatesActive - Recruiting
Alliance for Multispecialty Research, LLC
Wichita, Kansas 67205
United StatesCompleted
Alliance for Multispecialty Research, LLC
Lexington, Kentucky 40509
United StatesActive - Recruiting
Care Access - Lake Charles
Lake Charles, Louisiana 70601
United StatesActive - Recruiting
MedVadis Research Corporation
Waltham, Massachusetts 02451
United StatesActive - Recruiting
SKY Clinical Research Network Group-Quinn
Ridgeland, Mississippi 39157
United StatesActive - Recruiting
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi 39157
United StatesActive - Recruiting
Alliance for Multispecialty Research, LLC
Kansas City, Missouri 64114
United StatesActive - Recruiting
The Center for Pharmaceutical Research
Kansas City, Missouri 64114
United StatesActive - Recruiting
StudyMetrix Research
Saint Peters, Missouri 63303
United StatesActive - Recruiting
Clinvest Research LLC
Springfield, Missouri 65807
United StatesActive - Recruiting
Las Vegas Medical Research
Las Vegas, Nevada 89128
United StatesActive - Recruiting
UniMed Center
East Brunswick, New Jersey 08816
United StatesActive - Recruiting
North Suffolk Neurology
Port Jefferson Station, New York 11776
United StatesActive - Recruiting
Lucas Research - Hickory
Hickory, North Carolina 28601
United StatesActive - Recruiting
Lucas Research, Inc.
Hickory, North Carolina 28601
United StatesActive - Recruiting
Lucas Research, Inc
Morehead City, North Carolina 28557
United StatesActive - Recruiting
Velocity Clinical Research, Medford
Medford, Oregon 97504
United StatesActive - Recruiting
Tristar Clinical Investigations
Philadelphia, Pennsylvania 19114
United StatesActive - Recruiting
Suburban Research Associates
West Chester, Pennsylvania 19380
United StatesActive - Recruiting
Palmetto Clinical Research
Summerville, South Carolina 29485
United StatesSite Not Available
New Phase Research and Development
Knoxville, Tennessee 37909
United StatesActive - Recruiting
Trinity Clinical Research
Tullahoma, Tennessee 37388
United StatesSite Not Available
FutureSearch Trials of Neurology
Austin, Texas 78731
United StatesActive - Recruiting
Juno Research
Houston, Texas 77040
United StatesActive - Recruiting
Consano Clinical Research, LLC
Shavano Park, Texas 78231
United StatesActive - Recruiting
Velocity Clinical Research, Salt Lake City
West Jordan, Utah 84088
United StatesActive - Recruiting
Northwest Clinical Research Center
Bellevue, Washington 98007
United StatesActive - Recruiting
Rainier Clinical Research Center
Renton, Washington 98057
United StatesActive - Recruiting
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