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A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk (SURPASS-4)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03730662
Recruitment Status : Completed
First Posted : November 5, 2018
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of the trial is to assess the efficacy and safety of tirzepatide taken once a week to insulin glargine taken once daily in participants with type 2 diabetes and increased cardiovascular risk. The study will last about 108 weeks and may include up to 30 visits.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2002 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of LY3298176 Once Weekly Versus Insulin Glargine in Patients With Type 2 Diabetes and Increased Cardiovascular Risk (SURPASS-4)
Actual Study Start Date : November 20, 2018
Actual Primary Completion Date : January 22, 2021
Actual Study Completion Date : April 22, 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 Glargine
Insulin glargine administered SC once a day.
Drug: Insulin Glargine
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 (5 mg) [ Time Frame: Baseline, Week 52 ]
    Change from baseline in HbA1c (5 mg)

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

  3. Percentage of Participants with HbA1c of <7.0% [ Time Frame: Week 52 ]
    Percentage of participants with HbA1c of <7.0%

  4. Change from Baseline in Fasting Serum Glucose [ Time Frame: Baseline, Week 52 ]
    Change from baseline in fasting serum glucose

  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. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide [ Time Frame: Baseline through Week 52 ]
    PK: Steady state AUC of tirzepatide

  7. Rate of Total Hypoglycemia [ Time Frame: Baseline through Week 52 ]
    Rate of total hypoglycemia



Information from the National Library of Medicine

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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 ≥7.5% and ≤10.5%
  • Be on stable treatment with unchanged dose of at least 1 and no more than 3 types of oral antihyperglycemic drugs, which may only include metformin, SGLT-2 inhibitors, and/or sulfonylureas for at least 3 months before screening
  • Have increased risk for cardiovascular (CV) events
  • Be of stable weight (± 5%)
  • 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 immediate or urgent 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 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, SGLT-2 inhibitors, and/or sulfonylureas 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): NCT03730662


Locations
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United States, California
Advanced Research Center
Anaheim, California, United States, 92805
Valley Clinical Trials, Inc.
Covina, California, United States, 91723
Marin Endocrine Associates
Greenbrae, California, United States, 94904
National Research Institute
Huntington Park, California, United States, 90255
Scripps Whittier Diabetes Institute
La Jolla, California, United States, 92037
First Valley Medical Group
Lancaster, California, United States, 93534
National Research Institute
Los Angeles, California, United States, 90057
Catalina Research Institute, LLC
Montclair, California, United States, 91763
Monterey Endocrine & Diabetes Institute, Inc.
Monterey, California, United States, 93940
Valley Clinical Trials, Inc.
Northridge, California, United States, 91325
Desert Medical Group Inc
Palm Springs, California, United States, 92262
Havana Research Institute
Pasadena, California, United States, 91105
Western University of Health Sciences
Pomona, California, United States, 91766
LCGK Research
San Carlos, California, United States, 94070
Olive View Medical Center
Sylmar, California, United States, 91342
University Clinical Investigators, Inc.
Tustin, California, United States, 92780
Touro University
Vallejo, California, United States, 94592
Coastal Metabolic Research Centre
Ventura, California, United States, 93003
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Connecticut
Chase Medical Research, LLC
Waterbury, Connecticut, United States, 06708
United States, Florida
ALL Medical Research, LLC
Cooper City, Florida, United States, 33024
Advanced Pharma Research
Cutler Bay, Florida, United States, 33189
South Florida Wellness & Clinical Research Institute
Margate, Florida, United States, 33063
Suncoast Research Group, LLC
Miami, Florida, United States, 33135
New Horizon Research Center
Miami, Florida, United States, 33165
Clinical Neuroscience Solutions Inc
Orlando, Florida, United States, 32801
Progressive Medical Research
Port Orange, Florida, United States, 32127
United States, Georgia
Primary Care Specialists, LLC
Atlanta, Georgia, United States, 30312
United States, Idaho
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States, 83404
Solaris Clinical Research
Meridian, Idaho, United States, 83646
Saltzer Medical Group. P.A.
Nampa, Idaho, United States, 83686
United States, Illinois
Northwestern Feinberg School of Medicine
Chicago, Illinois, United States, 60611
NorthShore University HealthSystem
Skokie, Illinois, United States, 60077
United States, Iowa
University of Iowa Hospital & Clinic
Iowa City, Iowa, United States, 52242
Iowa Diabetes Research
West Des Moines, Iowa, United States, 50265
United States, Kansas
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, United States, 66606
United States, Kentucky
Robley Rex VAMC
Louisville, Kentucky, United States, 40206
United States, Massachusetts
NECCR PrimaCare Research, LLC
Fall River, Massachusetts, United States, 02721
United States, Michigan
AA Medical Research Center
Flint, Michigan, United States, 48504
Troy Internal Medicine, PC
Troy, Michigan, United States, 48098
United States, Missouri
Clinical Research Professionals
Chesterfield, Missouri, United States, 63005
United States, Montana
Glacier View Research Institute
Kalispell, Montana, United States, 59901
Montana Medical Research, Inc
Missoula, Montana, United States, 59808
United States, Nevada
Palm Research Center
Las Vegas, Nevada, United States, 89128
Palm Research Center
Las Vegas, Nevada, United States, 89148
United States, New Hampshire
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, United States, 03063
United States, North Carolina
PharmQuest
Greensboro, North Carolina, United States, 27408
United States, North Dakota
Lillestol Research LLC
Fargo, North Dakota, United States, 58104
United States, Ohio
Rapid Medical Research Inc
Cleveland, Ohio, United States, 44122
Ohio State Univ College Of Medicine
Columbus, Ohio, United States, 43210
Aventiv Research
Columbus, Ohio, United States, 43213
United States, Oklahoma
Intend Research
Norman, Oklahoma, United States, 73069
United States, Oregon
The Corvallis Clinic P.C.
Corvallis, Oregon, United States, 97330
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, United States, 15009
Capital Area Research
Camp Hill, Pennsylvania, United States, 17011
Detweiler Family Medicine
Lansdale, Pennsylvania, United States, 19446
Capital Area Research
Newport, Pennsylvania, United States, 17074
Parkside Family Medical
Philadelphia, Pennsylvania, United States, 19144
Preferred Primary Care Physicians- Bower Hill
Pittsburgh, Pennsylvania, United States, 15243
United States, South Carolina
Mountain View Clinical Research, Inc.
Greer, South Carolina, United States, 29651
The Research Center of the Upstate
Mauldin, South Carolina, United States, 29662
United States, Tennessee
Holston Medical Group Clinical Research
Kingsport, Tennessee, United States, 37660
New Phase Research & Development
Knoxville, Tennessee, United States, 37909
United States, Texas
Dallas Diabetes Endocrine Center
Dallas, Texas, United States, 75230
PCP for Life
Houston, Texas, United States, 77070
BFHC Research
San Antonio, Texas, United States, 78249
Consano Clinical Research
Shavano Park, Texas, United States, 78231
Martin Diagnostic Clinic
Tomball, Texas, United States, 77375
United States, Utah
Alpine Research Organization
Farmington, Utah, United States, 84025
United States, Virginia
Burke Internal Medicine & Research
Burke, Virginia, United States, 22015
United States, Washington
Private: Dr. Larry Stonesifer
Federal Way, Washington, United States, 98003
Capital Clinical Research Center
Olympia, Washington, United States, 98502
Walla Walla Clinic
Walla Walla, Washington, United States, 99362
Argentina
Centro de Investigaciones Metabólicas (CINME)
Caba, Buenos Aires, Argentina, C1056ABJ
Mautalen Salud e Investigación - Servicio de Endocrinología
Caba, Buenos Aires, Argentina, C1128AAF
Investigaciones Medicas IMOBA S.R.L.
Caba, Buenos Aires, Argentina, C1179AAB
CEDIC-Centro de Investigaciones Clinicas
Caba, Buenos Aires, Argentina, C1425DES
CEMEDIC
Caba, Buenos Aires, Argentina, C1440CFD
Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1425AGC
Centro de Investigacion y Prevencion Cardiovascular (CIPREC)
Ciudad Autonoma de, Buenos Aires, Argentina, C1119ACN
CIPADI
Godoy Cruz, Mendoza, Argentina, M5501ARP
AXISMED SRL - Bioclinica Research Network
Buenos Aires, Argentina, C1430CKE
Centro Médico Viamonte
Ciudad Autonoma de Buenos Aire, Argentina, C1120AAC
Instituto Centenario
Ciudad Autonoma de Buenos Aire, Argentina, C1204AAD
Cemediab - Centro Médico Diabetológico Dr. Alejandro Chertkoff
Ciudad Autonoma de Buenos Aire, Argentina, C1205AAO
Centro Diabetologico Dr Waitman
Cordoba, Argentina, 5000
Centro Medico Privado San Vicente Diabetes
Cordoba, Argentina, X5006CBI
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
Cordoba, Argentina, X5008HHW
Australia, New South Wales
Paratus Clinical Blacktown Clinic
Blacktown, New South Wales, Australia, 2148
Campbelltown Medical & Dental Centre
Campbelltown, New South Wales, Australia, 2560
Paratus Clinical Kanwal Clinic
Kanwal, New South Wales, Australia, 2259
The AIM Centre
Merewether, New South Wales, Australia, 2291
Royal North Shore Hospital
St. Leonards, New South Wales, Australia, 2065
Australia, Queensland
CORE Research Group Pty Ltd
Brisbane, Queensland, Australia, 4064
Morayfield Medical and Dental Centre
Morayfield, Queensland, Australia, 4506
AusTrials Pty Ltd
Sherwood, Queensland, Australia, 4075
Victoria Point Medical and Dental Centre
Victoria Point, Queensland, Australia, 4165
Australia, South Australia
GP Plus Marion
Oaklands Park, South Australia, Australia, 5046
Australia, Victoria
Eastern Clinical Research Unit
Box Hill, Victoria, Australia, 3128
Forest Hill Medical and Dental Centre
Forest Hill, Victoria, Australia, 3131
Barwon Health - The Geelong Hospital
Geelong, Victoria, Australia, 3220
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Fremantle Hospital
Fremantle, Western Australia, Australia, 6160
Brazil
Instituto de Ensino e Pesquisa Clinica do Ceara
Fortaleza, Ceara, Brazil, 60170-195
Centro de Pesquisa Clinica do Brasil
Brasilia, Distrito Federal, Brazil, 71625-009
Cedoes Centro Diagnostico Pequisa Osteoporose E Santo Ltd
Vitoria, ES, Brazil, 29055-450
Centro de Diabetes Curitiba
Curitiba, Parana, Brazil, 80810-040
CCBR Brasil Centro de Analises e Pesquisas Clínicas LTDA
Rio de Janeiro, RJ, Brazil, 22271-100
CPQuali Pesquisa Clínica Ltda.
São Paulo, SP, Brazil, 01228-000
Cpclin Centro de Pesquisas Clinicas
São Paulo, SP, Brazil, 01228-200
Centro de Pesq. em Diabetes e Doencas Endocrino Metabol.
Fortaleza, Brazil, 60430-350
Dr. Consulta Clínica Médica LTDA
São Paulo, Brazil, 01141-020
Canada, Alberta
LMC Manna Research
Calgary, Alberta, Canada, T2H 2G4
C-Health Diabetes and Endocrinology Clinic Calgary
Calgary, Alberta, Canada, T2V 4J2
Synergy Medical Research
Sherwood Park, Alberta, Canada, T8H 0N2
Canada, Ontario
LMC Endocrinology Centres Ltd.
Barrie, Ontario, Canada, L4N 7L3
LMC Endocrinology Centers Brampton
Brampton, Ontario, Canada, L6S 0C6
Aggarwal and Associates Ltd
Brampton, Ontario, Canada, L6T 0G1
LMC Endocrinology Centres Ltd.
Concord, Ontario, Canada, L4K 4M2
Milestone Research Inc.
London, Ontario, Canada, N5W6A2
LMC Endocrinology Centres Ltd.
Nepean, Ontario, Canada, K2J 0V2
Bluewater Clinical Research Group Inc
Sarnia, Ontario, Canada, N7T 4X3
Canadian Centre for Research on Diabetes
Smiths Falls, Ontario, Canada, K7A 4W8
Manna Research, Inc.
Stoney Creek, Ontario, Canada, L8J 3W2
Medicor Research Inc
Sudbury, Ontario, Canada, P3A 1W8
LMC Endocrinology Centres Ltd.
Toronto, Ontario, Canada, M4G 3E8
Sameh Fikry Medicine Professional Corporation
Waterloo, Ontario, Canada, N2J 1C4
Canada, Quebec
Q & T Research Outaouais
Gatineau, Quebec, Canada, J8Y 6S8
Centre De Recherche Clinique De Laval
Laval, Quebec, Canada, H7T 2P5
Manna Research (Quebec)
Levis, Quebec, Canada, G6W 0M5
LMC Endocrinology Centres Ltd.
Ville St-Laurent, Quebec, Canada, H4T 1Z9
Greece
Iatriko Palaiou Falirou, Medical Center
Palaio Faliro, Athens, Greece, 17562
Thermi Clinic
Thermi, Thessaloniki, Greece, 57001
University General Hospital of Larissa
Larissa, Greece, 41110
AHEPA Hospital
Thessaloniki, Greece, 54636
Euromedica - General Clinic of Thessaloniki
Thessaloniki, Greece, 54645
Israel
Ha'Emek Medical Center
Afula, Israel, 1834111
Soroka Medical Center
Beer Sheva, Israel, 8410101
Rambam Medical Center
Haifa, Israel, 3109601
Wolfson Medical Center
Holon, Israel, 5822012
Hadassah Medical Center
Jerusalem, Israel, 911201
Rabin Medical Center
Petach Tikva, Israel, 4941492
Sheba Medical Center
Ramat Gan, Israel, 5266202
Sakhnin Community Clinic, Clalit Health Services
Sakhnin, Israel, 3081000
Tel Aviv Sourasky Medical Center
Tel Aviv Jaffa, Israel, 6423906
Mexico
Instituto Jalisciense de Investigacion en Diabetes y Obesida
Guadalajara, Jalisco, Mexico, 04460
Diseno y Planeacion en Investigacion Medica S.C.
Guadalajara, Jalisco, Mexico, 44130
St. Lucas Clinical Research Center
Merida, Mexico State, Mexico, 97217
Unidad Medica para la Salud Integral (UMSI)
Monterrey, Nuevo León, Mexico, 66465
Centro de Estudios de Investigacion Metabolicos y Cardiovasc
Tampico, Tamaulipas, Mexico, 89000
Investigacion en Salud y Metabolismo S.C
Chihuahua, Mexico, 31217
Poland
Centralny Szpital Kliniczny MSWiA Klinika Dermatologiczna
Warszawa, Mazowieckie, Poland, 02-507
Poradnia Diabetologiczna SN ZOZ Lege Artis
Bialystok, Poland, 15-404
NZOZ Diab-Endo-Met
Krakow, Poland, 31-261
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Lodz, Poland, 90-242
NZOZ CenterMed Lublin
Lublin, Poland, 20-044
Gabinety Terpa
Lublin, Poland, 20-333
NZOZ Przychodnia Specjalistyczna MEDICA
Lublin, Poland, 20-538
Praktyka Lekarska
Poznan, Poland, 61-655
Nzoz Neuro - Kard
Poznan, Poland, 61-853
NZOZ Przychodnia Specjalistyczna Henryk RudzkiAndrzej Wittek
Ruda Slaska, Poland, 41-709
Woj. Zesp. Spec. Opieki Zdrowotnej
Wroclaw, Poland, 50-403
Puerto Rico
Emanuelli Research & Development Center, LLC
Arecibo, Puerto Rico, 00612
Manati Center for Clinical Research Inc
Manati, Puerto Rico, 00674
Ponce School of Medicine CAIMED Center
Ponce, Puerto Rico, 00716
Research and Cardiovascular Corp.
Ponce, Puerto Rico, 00717
University Of Puerto Rico
Rio Pedras, Puerto Rico, 00936
GCM Medical Group PSC
San Juan, Puerto Rico, 00909
Consultorio Medico
San Juan, Puerto Rico, 00921
Romania
SC Gama Diamed SRL
Mangalia, Constanta, Romania, 905500
Spitalul Judetean de Urgenta Satu Mare
Satu-Mare, Jud Satu-Mare, Romania, 440055
CMI DNBM Dr. Pop Lavinia
Baia Mare, Maramures, Romania, 430222
Cosamext SRL
Targu Mures, Mures, Romania, 540098
Centrul Medical Dr. Negrisanu
Timisoara, Timis, Romania, 300456
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
Brasov, Romania, 500283
Cabinetul Medical Nicodiab SRL
Bucharest, Romania, 010507
SC Nutrilife SRL
Bucuresti, Romania, 013671
Milena Sante SRL
Galati, Romania, 800001
Russian Federation
Arkhangelsk the first city clinical hospital
Arkhangelsk, Russian Federation, 163045
FSBI Endocrinological Research Center of the MOH of the ROF
Moscow, Russian Federation, 117036
Novosibirsk Regional Clinical Hospital
Novosibirsk, Russian Federation, 630087
Ryazan Regional Clinincal Cardiology Dispensary
Ryazan, Russian Federation, 390026
City Hospital of Saint Martyr Elizabeth
Saint Petersburg, Russian Federation, 193257
Medical Military Academy
Saint Petersburg, Russian Federation, 194044
SPb GUZ "Diagnostic Center #85"
Saint Petersburg, Russian Federation, 198255
City Consultative and Diagnostic Center
Saint-Petersburg, Russian Federation, 194354
Regional Clinical Hospital
Saratov, Russian Federation, 410053
Research & Practice Ltd
Yaroslavl, Russian Federation, 150003
Slovakia
Human care s.r.o.
Kosice, Slovak Republic, Slovakia, 04012
MediVet s.r.o.
Malacky, Slovak Republic, Slovakia, 90101
Areteus s.r.o.
Trebisov, Slovak Republic, Slovakia, 07501
DIA-MED CENTRUM s.r.o.
Puchov, Slovakia, 02001
Tatratrial s.r.o.
Roznava, Slovakia, 04801
MEDI-DIA s.r.o.
Sabinov, Slovakia, 08301
Spain
Hospital Universitario Marques De Valdecilla
Santander, Cantabria, Spain, 39011
Hospital Universitario Quiron Madrid
Pozuelo de Alarcon, Madrid, Spain, 28223
Hospital de la Ribera
Alcira, Valencia, Spain, 46600
Instituto de Ciencias medicas
Alicante, Spain, 03004
Centro Periférico de Especialidades Bola Azul
Almeria, Spain, 04009
Hospital Quironsalud Barcelona- END
Barcelona, Spain, 08023
Hospital Clinico Universitario San Cecilio
Granada, Spain, 18016
Complexo Hospitalario Universitario A Coruña, CHUAC
La Coruña, Spain, 15006
Centro Especialidades San Jose Obrero (Barbarela)
Malaga, Spain, 29006
Clinica Juaneda
Palma de Mallorca, Spain, 07014
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41009
Clinica Nuevas Tecnologias en Diabetes y Endocrinologia
Seville, Spain, 41003
Taiwan
Cardinal Tien Hospital
Sindian City, Taipei County, Taiwan, 23148
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City, Taiwan, 833
Chung Shan Medical University Hospital
Taichung City, Taiwan, 40201
Kuang Tien General Hospital
Taichung County, Taiwan, 433
China Medical University Hospital
Taichung, Taiwan, 40447
Chi-Mei Medical Center
Tainan City, Taiwan, 71004
National Cheng Kung University Hospital
Tainan, Taiwan, 70403
National Taiwan University Hospital
Taipei City, Taiwan, 10048
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
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: NCT03730662    
Other Study ID Numbers: 17072
I8F-MC-GPGM ( Other Identifier: Eli Lilly and Company )
2018-002618-11 ( EudraCT Number )
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: June 11, 2021
Last Verified: June 2021
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: https://vivli.org/

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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:
GIP
GLP-1
glucose metabolism disorders
metabolic diseases
endocrine system diseases
cardiovascular risk
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Glargine
LY3298176
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists