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A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes (SURPASS-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03882970
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to compare the effect of the study drug tirzepatide to insulin degludec on blood sugar levels in participants with type 2 diabetes. The study will last about 59 weeks and may include up to 22 visits.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Tirzepatide Drug: Insulin Degludec Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Phase 3, Open-Label Trial Comparing the Effect of LY3298176 Versus Titrated Insulin Degludec on Glycemic Control in Patients With Type 2 Diabetes
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : October 19, 2020
Estimated Study Completion Date : January 8, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 5 mg Tirzepatide
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Experimental: 10 mg Tirzepatide
10 mg tirzepatide administered SC once a week.
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Experimental: 15 mg Tirzepatide
15 mg tirzepatide administered SC once a week.
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Active Comparator: Insulin Degludec
Insulin degludec administered SC once a day.
Drug: Insulin Degludec
Administered SC




Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in HbA1c (10 mg and 15 mg)


Secondary Outcome Measures :
  1. Change from Baseline in HbA1c [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in HbA1c

  2. Change from Baseline in Body Weight [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in Body Weight

  3. Change from Baseline in Fasting Serum Glucose [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in Fasting Serum Glucose

  4. Percentage of Participants Achieving an HbA1c Target Value of <7% [ Time Frame: Week 52 ]
    Percentage of Participants Achieving an HbA1c Target Value of <7%

  5. Change from Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in 7-Point SMBG Values

  6. Percentage of Participants who Achieved Weight Loss ≥5% [ Time Frame: Week 52 ]
    Percentage of Participants who Achieved Weight Loss ≥5%

  7. Change from Baseline in Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ) [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in Diabetes Treatment Satisfaction as Measured by the DTSQ

  8. Rate of Documented Symptomatic Hypoglycemic Episodes [ Time Frame: Baseline through Week 52 ]
    Rate of Documented Symptomatic Hypoglycemic Episodes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must:

    • Have been diagnosed with type 2 diabetes mellitus (T2DM)
    • Have HbA1c between ≥7.0% and ≤10.5%
    • Be on stable treatment with unchanged dose of metformin or metformin plus an SGLT-2 inhibitor for at least 3 months before screening
    • Be of stable weight (± 5%) for at least 3 months before screening
    • Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening

Exclusion Criteria:

  • Participants must not:

    • Have type 1 diabetes mellitus
    • Have had chronic or acute pancreatitis any time prior to study entry
    • Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment
    • Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss
    • Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level >3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if there ALT level is ≤3.0 the ULN for the reference range
    • Have an estimated glomerular filtration rate <45 mL/minute/1.73 m2 (or lower than the country specific threshold for using the protocol required dose of metformin per local label)
    • Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months
    • Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
    • Have been taking any other diabetes medicines other than metformin, or metformin plus an SGLT-2 inhibitor during the last 3 months
    • Have been taking weight loss drugs, including over-the-counter medications during the last 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03882970


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com

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Locations
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United States, Arkansas
Arkansas Clinical Research Recruiting
Little Rock, Arkansas, United States, 72205
Contact    501-907-9170      
Principal Investigator: Kevin D Roberts         
United States, California
Valley Research Recruiting
Fresno, California, United States, 93720
Contact    559-261-0992      
Principal Investigator: Paul C Norwood         
National Research Institute Recruiting
Huntington Park, California, United States, 90255
Contact    323-588-1968      
Principal Investigator: Stanley Hsia         
National Research Institute Recruiting
Los Angeles, California, United States, 90057
Contact    213-413-2500      
Principal Investigator: Juan P Frias         
Catalina Research Institute, LLC Recruiting
Montclair, California, United States, 91763
Contact    909-590-8409      
Principal Investigator: Rizwana H. Mohseni         
Valley Clinical Trials, Inc. Recruiting
Northridge, California, United States, 91325
Contact    818-280-4220      
Principal Investigator: Christopher Chow         
National Research Institute Recruiting
Panorama City, California, United States, 91402
Contact    818-532-6880      
Principal Investigator: Parvin D Syal         
Encompass Clinical Research Recruiting
Spring Valley, California, United States, 91978
Contact    619-660-9068      
Principal Investigator: Hanid Audish         
University Clinical Investigators, Inc. Recruiting
Tustin, California, United States, 92780
Contact    714-734-7944      
Principal Investigator: Joanna T Van         
United States, Connecticut
Chase Medical Research, LLC Recruiting
Waterbury, Connecticut, United States, 06708
Contact    203-419-4420      
Principal Investigator: Joseph Soufer         
United States, Florida
Indago Research & Health Center, Inc. Recruiting
Hialeah, Florida, United States, 33012
Contact    305-825-6588      
Principal Investigator: Jose Cardona         
East Coast Clinical Research Recruiting
Jacksonville, Florida, United States, 32204
Contact    904-384-2240      
Principal Investigator: James S Magee         
East Coast Institute For Research Recruiting
Jacksonville, Florida, United States, 32216
Contact    904-854-1354      
Principal Investigator: Mae Sheikh-Ali         
Bayside Clinical Research, LLC Recruiting
New Port Richey, Florida, United States, 34655
Contact    727-853-1800      
Principal Investigator: Tatiana Hernandez         
United States, Georgia
East Coast Institute For Research Recruiting
Macon, Georgia, United States, 31210
Contact    478-746-8626      
Principal Investigator: Thomas C Jones         
Sky Clinical Research Network Recruiting
Union City, Georgia, United States, 30291
Contact    888-659-4363      
Principal Investigator: Dwight Blake         
United States, Idaho
Elite Clinical Trials LLLP Recruiting
Blackfoot, Idaho, United States, 83221
Contact    208-643-0006      
Principal Investigator: Gary Soucie         
Humphreys Diabetes Center Recruiting
Boise, Idaho, United States, 83702
Contact    208-287-9429      
Principal Investigator: Sherwin D'Souza         
Rocky Mountain Diabetes and Osteoporosis Center Recruiting
Idaho Falls, Idaho, United States, 83404
Contact    208-542-6005      
Principal Investigator: Carl D Vance         
United States, Illinois
Springfield Diabetes & Endocrine Center Recruiting
Springfield, Illinois, United States, 62711
Contact    217-787-8870      
Principal Investigator: Diana Widicus         
United States, Louisiana
Crescent City Clinical Research Recruiting
Metairie, Louisiana, United States, 70006
Contact    985-273-5158      
Principal Investigator: Harold Miller         
United States, Maryland
Endocrine and Metabolic Consultants Recruiting
Rockville, Maryland, United States, 20852
Contact    301-770-7373      
Principal Investigator: Michael Dempsey         
United States, Michigan
Troy Internal Medicine, PC Recruiting
Troy, Michigan, United States, 48098
Contact    248-312-0025      
Principal Investigator: Neil Fraser         
United States, Minnesota
International Diabetes Center Recruiting
Minneapolis, Minnesota, United States, 55416
Contact    952-993-1517      
Principal Investigator: Thomas Martens         
United States, Missouri
Clinical Research Professionals Recruiting
Chesterfield, Missouri, United States, 63005
Contact    636-220-1200      
Principal Investigator: Timothy W. Jennings         
United States, Nevada
Palm Research Center Recruiting
Las Vegas, Nevada, United States, 89128
Contact    702-826-2795      
Principal Investigator: Samer Nakhle         
Palm Research Center Recruiting
Las Vegas, Nevada, United States, 89148
Contact    702-736-5163      
Principal Investigator: Betsy M Palal         
United States, Ohio
Aventiv Research Recruiting
Columbus, Ohio, United States, 43213
Contact    614-501-6164      
Principal Investigator: Samir Arora         
United States, Oregon
The Corvallis Clinic P.C. Recruiting
Corvallis, Oregon, United States, 97330
Contact    541-754-1398      
Principal Investigator: Michael C Chen         
United States, Pennsylvania
Heritage Valley Medical Group, Inc. Recruiting
Beaver, Pennsylvania, United States, 15009
Contact    724-774-7743      
Principal Investigator: Michael J Oliver         
Detweiler Family Medicine Recruiting
Lansdale, Pennsylvania, United States, 19446
Contact    215-368-1900      
Principal Investigator: Evan Kessler         
United States, Texas
Office of Dr. Osvaldo Brusco Recruiting
Corpus Christi, Texas, United States, 78414
Contact    361-885-0448      
Principal Investigator: Osvaldo A Brusco         
Consano Clinical Research Recruiting
Shavano Park, Texas, United States, 78231
Contact    210-545-4900      
Principal Investigator: Michelle Welch         
Argentina
Mautalen Salud e Investigación - Servicio de Endocrinología Recruiting
Caba, Buenos Aires, Argentina, C1128AAF
Contact    541145143406      
Principal Investigator: Jose Osvaldo Fretes         
Investigaciones Medicas IMOBA S.R.L. Recruiting
Caba, Buenos Aires, Argentina, C1179AAB
Contact    00541149831589      
Principal Investigator: Silvia Orio         
CEDIC-Centro de Investigaciones Clinicas Recruiting
Caba, Buenos Aires, Argentina, C1425DES
Contact    541148238701      
Principal Investigator: Elizabeth Gelersztein         
Centro de Investigacion y Prevencion Cardiovascular (CIPREC) Recruiting
Ciudad Autonoma de, Buenos Aires, Argentina, C1119ACN
Contact    541148273866      
Principal Investigator: Cesar Javier Zaidman         
CIPADI Recruiting
Godoy Cruz, Mendoza, Argentina, M5501ARP
Contact    542614200345      
Principal Investigator: Pedro Calella         
AXISMED SRL - Bioclinica Research Network Recruiting
Buenos Aires, Argentina, C1430CKE
Contact    541145445522      
Principal Investigator: Jorge Glenny         
Centro Médico Viamonte Recruiting
Ciudad Autonoma de Buenos Aire, Argentina, C1120AAC
Contact    541149640500      
Principal Investigator: Diego Aizenberg         
Instituto Centenario Recruiting
Ciudad Autonoma de Buenos Aire, Argentina, C1204AAD
Contact    541149810256      
Principal Investigator: Susana Salzberg         
CENUDIAB Recruiting
Ciudad Autonoma de Buenos Aire, Argentina, C1440AAD
Contact    541146820269      
Principal Investigator: Alejandra Oviedo         
Austria
Landesklinikum Korneuburg-Stockerau, Standort Stockerau Active, not recruiting
Stockerau, Niederösterreich, Austria, 2000
Universitätsklinikum Graz Active, not recruiting
Graz, Steiermark, Austria, 8036
Universitätsklinikum Salzburg Active, not recruiting
Salzburg, Austria, 5020
KA Rudolfstiftung Active, not recruiting
Wien, Austria, 1030
Greece
Iatriko Palaiou Falirou, Medical Center Recruiting
Palaio Faliro, Athens, Greece, 17562
Contact    00302109892300      
Principal Investigator: Ioannis Doupis         
Laiko General Hospital of Athens Recruiting
Ampelokipoi, Attica, Greece, 11527
Contact    00302107462683      
Principal Investigator: Nikolaos Tentolouris         
Gen Hospital of Athens G Gennimatas Recruiting
Athens, Attiki, Greece, 11527
Contact    0030213203491      
Principal Investigator: Theodora Kounadi         
General Hospital of Thessaloniki Papageorgiou Recruiting
N. Efkarpia, Thessaloniki, Greece, 56403
Contact    00302313323181      
Principal Investigator: Glykeria Tzatzagou         
Thermi Clinic Recruiting
Thermi, Thessaloniki, Greece, 57001
Contact    00302310024800      
Principal Investigator: Emmanouil Pagkalos         
Athens Euroclinic Recruiting
Athens, Greece, 11521
Contact    302106416600      
Principal Investigator: Mariana Benroubi         
University General Hospital of Larissa Recruiting
Larissa, Greece, 41110
Contact    00302413501942      
Principal Investigator: Alexandra Bargiota         
AHEPA Hospital Recruiting
Thessaloniki, Greece, 54636
Contact    00302310994706      
Principal Investigator: Kalliopi Kotsa         
Ippokrateio General Hospital of Thessaloniki Recruiting
Thessaloniki, Greece, 54639
Contact    0030310837921      
Principal Investigator: Christos Sampanis         
Euromedica - General Clinic of Thessaloniki Recruiting
Thessaloniki, Greece, 54645
Contact    00302310895100      
Principal Investigator: Zadalla Mouslech         
Hungary
Kenezy Gyula Korhaz es Rendelointezet Active, not recruiting
Debrecen, Hajdu-Bihar, Hungary, 4031
Szent Margit Rendelointezet Active, not recruiting
Budapest, Hungary, 1032
ClinDiab Kft. Active, not recruiting
Budapest, Hungary, 1089
XIII.ker Onkormanyzat Egeszsegugyi Szolgalat Active, not recruiting
Budapest, Hungary, 1139
Strazsahegy Medicina Bt. Active, not recruiting
Budapest, Hungary, 1171
TRANTOR 99 Bt. Active, not recruiting
Budapest, Hungary, 1213
Kanizsai Dorottya Korhaz Active, not recruiting
Nagykanizsa, Hungary, 8800
Zala Megyei Szent Rafael Korhaz Active, not recruiting
Zalaegerszeg, Hungary, 8900
Italy
Azienda ospedaliero-universitaria Mater Domini Active, not recruiting
Germaneto, Catanzaro, Italy, 88100
Policlinico Univ. Agostino Gemelli Active, not recruiting
Roma, Lazio, Italy, 00168
Centro Cardiologico Monzino, IRCCS Active, not recruiting
Milano, MI, Italy, 20138
Azienda Ospedaliera Policlinico Consorziale Active, not recruiting
Bari, Italy, 70124
Azienda Ospedaliera Papa Giovanni XXIII Active, not recruiting
Bergamo, Italy, 24128
Ospedale Santa Maria Goretti Active, not recruiting
Latina, Italy, 04100
Korea, Republic of
Bucheon St. Mary's Hospital Recruiting
Bucheon,, Gyeonggi-do, Korea, Republic of, 14647
Contact    323402024      
Principal Investigator: Soon jib Yoo         
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact    82317877035      
Principal Investigator: Soo Lim         
Hanyang University Guri Hospital Recruiting
Guri-si, Gyeonggido, Korea, Republic of, 11923
Contact    821052825285      
Principal Investigator: Chang Beom Lee         
Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Korea, Republic of, 06591
Contact    82222586007      
Principal Investigator: Kun-Ho Yoon         
Korea University Ansan Hospital Recruiting
Ansan-si, Korea, Republic of, 15355
Contact    82314125952      
Principal Investigator: Nan Hee Kim         
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 02841
Contact    8229205890      
Principal Investigator: Sin Gon Kim         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact    82220721965      
Principal Investigator: Young Min Cho         
Severance Hospital Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Contact    82222280516      
Principal Investigator: Byung Wan Lee         
Kyunghee University Hospital at Gangdong Recruiting
Seoul, Korea, Republic of, 05278
Contact    8224406125      
Principal Investigator: Kyu Jeung Ahn         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact    82234103431      
Principal Investigator: Moon-Kyu Lee         
Poland
Ambulatorium Barbara Bazela Active, not recruiting
Elblag, Warminsko-Mazurki, Poland, 82300
NZOZ ZDROWIE Osteo-Medic Active, not recruiting
Bialystok, Poland, 15-351
Poradnia Diabetologiczna SN ZOZ Lege Artis Active, not recruiting
Bialystok, Poland, 15-404
NZOZ Diab-Endo-Met Active, not recruiting
Krakow, Poland, 31-261
Gabinet Lekarski Malgorzata Saryusz-Wolska Active, not recruiting
Lodz, Poland, 90-132
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. Active, not recruiting
Lodz, Poland, 90-242
NZOZ Przychodnia Specjalistyczna MEDICA Active, not recruiting
Lublin, Poland, 20-538
NZOZ Przychodnia Specjalistyczna Henryk RudzkiAndrzej Wittek Active, not recruiting
Ruda Slaska, Poland, 41-709
Puerto Rico
Latin Clinical Trial Center Recruiting
San Juan, Puerto Rico, 00909
Contact    7872494763      
Principal Investigator: Carlos A Sariol-Curbelo         
GCM Medical Group PSC Recruiting
San Juan, Puerto Rico, 00917
Contact    7877268396      
Principal Investigator: Gregorio A. Cortes-Maisonet         
San Miguel Medical Recruiting
Trujillo Alto, Puerto Rico, 00976
Contact    7875032699      
Principal Investigator: Elba A Perez Vargas         
Romania
S. C. Grandmed S.R.L., Str. Active, not recruiting
Oradea, Bihor, Romania, 410159
Spitalul Judetean de Urgenta Satu Mare Active, not recruiting
Satu-Mare, Jud Satu-Mare, Romania, 440055
SC Diamed Obesity SRL Active, not recruiting
Galati, Judetul Galati, Romania, 800291
CMI DNBM Dr. Pop Lavinia Active, not recruiting
Baia Mare, Maramures, Romania, 430222
Cosamext SRL Active, not recruiting
Targu Mures, Mures, Romania, 540098
Societatea Civila Medicala "Dr. Paveliu" Active, not recruiting
Bucuresti, Sect.5, Romania, 050538
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL Active, not recruiting
Brasov, Romania, 500283
Cabinetul Medical Nicodiab SRL Active, not recruiting
Bucharest, Romania, 010507
SC Nutrilife SRL Active, not recruiting
Bucuresti, Romania, 013671
Consultmed SRL Active, not recruiting
Iasi, Romania, 700547
Spain
Hospital Infanta Luisa Active, not recruiting
Sevilla, Andalucía, Spain, 41010
Hospital Universitario Marques De Valdecilla Active, not recruiting
Santander, Cantabria, Spain, 39011
Hospital Universitario Quiron Madrid Active, not recruiting
Pozuelo de Alarcon, Madrid, Spain, 28223
Instituto de Ciencias medicas Active, not recruiting
Alicante, Spain, 03004
Hospital Clinico Universitario San Cecilio Active, not recruiting
Granada, Spain, 18016
Clinica Juaneda Active, not recruiting
Palma de Mallorca, Spain, 07014
Clinica Nuevas Tecnologias en Diabetes y Endocrinologia Active, not recruiting
Seville, Spain, 41003
Policlinica Galileo Active, not recruiting
Teruel, Spain, 44002
Taiwan
Changhua Christian Hospital Recruiting
Changhua, Taiwan, 500
Contact    8867238595 ext.3239      
Principal Investigator: Shih-Te Tu         
Chang Gung Memorial Hospital - Kaohsiung Recruiting
Kaohsiung City, Taiwan, 833
Contact    88677317123 ext. 3035      
Principal Investigator: Jung-Fu Chen         
Taipei Medical University- Shuang Ho Hospital Recruiting
New Taipei, Taiwan, 23561
Contact    886222490088      
Principal Investigator: Chung-Ze Wu         
Chung Shan Medical University Hospital Recruiting
Taichung City, Taiwan, 40201
Contact    886424739595 ext.34111      
Principal Investigator: Chien-Ning Huang         
Kuang Tien General Hospital Recruiting
Taichung County, Taiwan, 433
Contact    886426625111 ext 2189      
Principal Investigator: Shih-Ting Tseng         
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705, ROC
Contact    886423592525 ext.3061      
Principal Investigator: I-Te Lee         
Chi-Mei Medical Center Recruiting
Tainan City, Taiwan, 71004
Contact    88662812811 ext.55910      
Principal Investigator: Kai-Jen Tien         
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 70403
Contact    88662353535 ext 4577      
Principal Investigator: Horng-Yih Ou         
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Contact    886228757516      
Principal Investigator: Liang-Yu Lin         
Ukraine
Dnipro City Clinical Hospital #9 Active, not recruiting
Dnipro, Ukraine, 49023
V.P. Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine Active, not recruiting
Kyiv, Ukraine, 04114
Communal Institution "Poltava Reg.Cl.H. n.a.M.V.Sklifosovskogo" Active, not recruiting
Poltava, Ukraine, 36011
Vinnytsia Regional Clinical Highly Specialized Endocrinology Center Active, not recruiting
Vinnytsia, Ukraine, 21000
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03882970     History of Changes
Other Study ID Numbers: 16997
I8F-MC-GPGH ( Other Identifier: Eli Lilly and Company )
2018-003422-84 ( EudraCT Number )
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
T2DM
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs