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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)

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ClinicalTrials.gov Identifier: NCT03730662
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : February 19, 2019
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1878 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
Estimated Primary Completion Date : May 15, 2021
Estimated Study Completion Date : June 15, 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


Contacts
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
United States, Alabama
Alabama Medical Group Recruiting
Mobile, Alabama, United States, 36608
Contact    251-402-2101      
Principal Investigator: Judson K Menefee         
United States, California
Advanced Research Center Recruiting
Anaheim, California, United States, 92805
Contact    714-999-6688      
Principal Investigator: Patrick Walsh         
Marin Endocrine Associates Recruiting
Greenbrae, California, United States, 94904
Contact    415-461-9113      
Principal Investigator: Linda M Gaudiani         
Diabetes/Lipid Management Center Not yet recruiting
Huntington Beach, California, United States, 92648
Contact    714-375-7386      
Principal Investigator: Paul Rosenblit         
National Research Institute Recruiting
Huntington Park, California, United States, 90255
Contact    323-588-1968      
Principal Investigator: Stanley Hsia         
Scripps Whittier Diabetes Institute Not yet recruiting
La Jolla, California, United States, 92037
Contact    858-678-7077      
Principal Investigator: Athena Philis-Tsimikas         
First Valley Medical Group Recruiting
Lancaster, California, United States, 93534
Contact    646-642-6189      
Principal Investigator: Kanagaratnam Sivalingam         
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    909-203-4707      
Principal Investigator: Rizwana H. Mohseni         
Monterey Endocrine & Diabetes Institute, Inc. Recruiting
Monterey, California, United States, 93940
Contact    831-375-6334      
Principal Investigator: James W Chu         
Valley Clinical Trials, Inc. Recruiting
Northridge, California, United States, 91325
Contact    818-280-4220      
Principal Investigator: Christopher Chow         
Desert Medical Group Inc Recruiting
Palm Springs, California, United States, 92262
Contact    760-320-9505      
Principal Investigator: Michael R Jardula         
Havana Research Institute Recruiting
Pasadena, California, United States, 91105
Contact    626-395-7732      
Principal Investigator: John K De Beixedon         
Western University of Health Sciences Not yet recruiting
Pomona, California, United States, 91766
Contact    909-706-3818      
Principal Investigator: Airani Sathananthan         
LCGK Research Recruiting
San Carlos, California, United States, 94070
Contact    650-591-9933      
Principal Investigator: Leila Chaychi         
Olive View Medical Center Not yet recruiting
Sylmar, California, United States, 91342
Contact    747-210-3205      
Principal Investigator: Vahid Mahabadi         
University Clinical Investigators, Inc. Recruiting
Tustin, California, United States, 92780
Contact    714-760-9317      
Principal Investigator: Joanna T Van         
Touro University Recruiting
Vallejo, California, United States, 94592
Contact    707-638-5969      
Principal Investigator: Jay Shubrook         
Coastal Metabolic Research Centre Recruiting
Ventura, California, United States, 93003
Contact    805-658-8460      
Principal Investigator: Ronald H Chochinov         
Diablo Clinical Research Recruiting
Walnut Creek, California, United States, 94598
Contact    925-930-7267      
Principal Investigator: Helen L. Stacey         
United States, Connecticut
Chase Medical Research, LLC Recruiting
Waterbury, Connecticut, United States, 06708
Contact    203-419-4420      
Principal Investigator: Joseph Soufer         
United States, Florida
Advanced Pharma Research Recruiting
Cutler Bay, Florida, United States, 33189
Contact    786-234-3709      
Principal Investigator: Miguel Mujica-Baella         
South Florida Wellness & Clinical Research Institute Recruiting
Margate, Florida, United States, 33063
Contact    954-582-7007      
Principal Investigator: Juan P Loy         
Suncoast Research Group, LLC Recruiting
Miami, Florida, United States, 33135
Contact    305-631-6704      
Principal Investigator: Mark E. Kutner         
New Horizon Research Center Recruiting
Miami, Florida, United States, 33175
Contact    305-226-3933      
Principal Investigator: Lazaro Nunez         
Clinical Neuroscience Solutions Inc Recruiting
Orlando, Florida, United States, 32806
Contact    407-425-1000      
Principal Investigator: Michael E Dever         
United States, Georgia
Primary Care Specialists, LLC Recruiting
Atlanta, Georgia, United States, 30312
Contact    678-705-2355      
Principal Investigator: Courtney Shelton         
Herman Clinical Research, LLC Recruiting
Suwanee, Georgia, United States, 30024
Contact    6782053456      
Principal Investigator: Lee Edward Herman         
United States, Idaho
Rocky Mountain Diabetes and Osteoporosis Center Recruiting
Idaho Falls, Idaho, United States, 83404
Contact    208-542-6005      
Principal Investigator: Carl D Vance         
Solaris Clinical Research Recruiting
Meridian, Idaho, United States, 83646
Contact    208-288-0123      
Principal Investigator: David Butuk         
Saltzer Medical Group. P.A. Recruiting
Nampa, Idaho, United States, 83686
Contact    208-463-3081      
Principal Investigator: Stanley Stringam         
United States, Illinois
Northwestern Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact    312-695-7970      
Principal Investigator: Grazia Aleppo         
NorthShore University HealthSystem Not yet recruiting
Skokie, Illinois, United States, 60077
Contact    847-570-2956      
Principal Investigator: Liana Billings         
United States, Iowa
Iderc, P.L.C. Recruiting
West Des Moines, Iowa, United States, 50265
Contact    515-329-6800      
Principal Investigator: Anuj Bhargava         
United States, Kansas
Cotton O'Neil Diabetes and Endocrinology Center Recruiting
Topeka, Kansas, United States, 66606
Contact    785-368-0490      
Principal Investigator: Alan G Wynne         
United States, Kentucky
Robley Rex VAMC Not yet recruiting
Louisville, Kentucky, United States, 40206
Contact    502-287-5128      
Principal Investigator: Sathya S Krishnasamy         
United States, Massachusetts
NECCR PrimaCare Research, LLC Recruiting
Fall River, Massachusetts, United States, 02721
Contact    508-672-7450      
Principal Investigator: Ehab Sorial         
United States, Michigan
AA Medical Research Center Recruiting
Flint, Michigan, United States, 48504
Contact    810-237-1125      
Principal Investigator: Ahmed Arif         
Troy Internal Medicine, PC Recruiting
Troy, Michigan, United States, 48098
Contact    248-312-0025      
Principal Investigator: Neil Fraser         
United States, Missouri
Clinical Research Professionals Recruiting
Chesterfield, Missouri, United States, 63005
Contact    636-220-1200      
Principal Investigator: Timothy W. Jennings         
United States, Montana
Glacier View Research Institute Recruiting
Kalispell, Montana, United States, 59901
Contact    406-751-5309      
Principal Investigator: Jose de Souza         
Montana Medical Research, Inc Recruiting
Missoula, Montana, United States, 59808
Contact    406-549-1124      
Principal Investigator: Clancy L Cone         
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    702-736-5161      
Principal Investigator: Betsy M Palal         
United States, New Hampshire
Southern New Hampshire Diabetes and Endocrinology Recruiting
Nashua, New Hampshire, United States, 03063
Contact    603-577-5760      
Principal Investigator: Robert J Silver         
United States, North Carolina
PharmQuest Recruiting
Greensboro, North Carolina, United States, 27408
Contact    336-574-8020      
Principal Investigator: Alexander V. Murray         
United States, Ohio
Rapid Medical Research Inc Recruiting
Cleveland, Ohio, United States, 44122
Contact    216-682-0320      
Principal Investigator: Toby J Briskin         
Ohio State Univ College Of Medicine Recruiting
Columbus, Ohio, United States, 43210
Contact    614-688-6885      
Principal Investigator: Kathleen Dungan         
Aventiv Research Recruiting
Columbus, Ohio, United States, 43213
Contact    614-501-6164      
Principal Investigator: Samir Arora         
United States, Oklahoma
Intend Research Recruiting
Norman, Oklahoma, United States, 73069
Contact    405-701-8999      
Principal Investigator: Lisa Connery         
United States, Oregon
The Corvallis Clinic P.C. Recruiting
Corvallis, Oregon, United States, 97330
Contact    541-754-1398      
Principal Investigator: Michael C Chen         
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact    503-494-4704      
Principal Investigator: Andrew J Ahmann         
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: Michael Parke         
Preferred Primary Care Physicians- Bower Hill Recruiting
Pittsburgh, Pennsylvania, United States, 15243
Contact    412-942-0023      
Principal Investigator: Raman Purighalla         
United States, South Carolina
The Research Center of the Upstate Recruiting
Mauldin, South Carolina, United States, 29662
Contact    864-680-0762      
Principal Investigator: Anne Tuggle         
United States, Tennessee
Premier Medical Group, PC Recruiting
Clarksville, Tennessee, United States, 37040
Contact    931-245-8444      
Principal Investigator: Jacqueline Milam         
New Phase Research & Development Recruiting
Knoxville, Tennessee, United States, 37909
Contact    865-200-8364      
Principal Investigator: Evelyne Davidson         
United States, Texas
Dallas Diabetes Endocrine Center Recruiting
Dallas, Texas, United States, 75230
Contact    972-566-7799      
Principal Investigator: Julio Rosenstock         
PCP for Life Recruiting
Houston, Texas, United States, 77070
Contact    281-370-7272      
Principal Investigator: Najmuddin Karimjee         
BFHC Research Recruiting
San Antonio, Texas, United States, 78249
Contact    210-695-1900      
Principal Investigator: Ramon Reyes         
Consano Clinical Research Recruiting
Shavano Park, Texas, United States, 78231
Contact    210-545-4900      
Principal Investigator: Michelle Welch         
Martin Diagnostic Clinic Recruiting
Tomball, Texas, United States, 77375
Contact    832-843-0200      
Principal Investigator: Earl E Martin         
United States, Virginia
Burke Internal Medicine & Research Recruiting
Burke, Virginia, United States, 22015
Contact    703-455-9711      
Principal Investigator: Nashwa Gabra         
United States, Washington
Private: Dr. Larry Stonesifer Recruiting
Federal Way, Washington, United States, 98003
Contact    253-927-7256      
Principal Investigator: Larry Stonesifer         
Capital Clincial Research Center Recruiting
Olympia, Washington, United States, 98502
Contact    360-786-0692      
Principal Investigator: Eric J. Klein         
Walla Walla Clinic Recruiting
Walla Walla, Washington, United States, 99362
Contact    509-525-3720      
Principal Investigator: Eric M. Ball         
Argentina
CEDIC-Centro de Investigaciones Clinicas Recruiting
Caba, Buenos Aires, Argentina, 1425
Contact    541148238701      
Principal Investigator: Elizabeth Gelersztein         
Investigaciones Medicas IMOBA S.R.L. Recruiting
Caba, Buenos Aires, Argentina, C1179AAB
Contact    541149831589      
Principal Investigator: Silvia Orio         
Centro de Investigaciones Metabólicas (CINME) Recruiting
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1056ABJ
Contact    541150319914      
Principal Investigator: Monica Marcela Meritano         
Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada Recruiting
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1425AGC
Contact    541148019001      
Principal Investigator: Sonia Sassone         
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         
Mautalen Salud e Investigación - Servicio de Endocrinología Recruiting
Ciudad Autonoma De Buenos Air, Argentina, C1128AAF
Contact    541145143406      
Principal Investigator: Jose Osvaldo Fretes         
Centro Diabetologico Dr Waitman Not yet recruiting
Cordoba, Argentina, 5000
Contact    543514245162      
Principal Investigator: Silvana Ernestina Solis         
Centro Medico Privado San Vicente Diabetes Not yet recruiting
Cordoba, Argentina, X5006CBI
Contact    543514558041      
Principal Investigator: Andrea Steinacher         
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC Recruiting
Cordoba, Argentina, X5008HHW
Contact    5403514766837      
Principal Investigator: Lucrecia Nardone         
Australia, New South Wales
The AIM Centre Recruiting
Merewether, New South Wales, Australia, 2291
Contact    61249576754      
Principal Investigator: Claire Morbey         
Royal North Shore Hospital Recruiting
St. Leonards, New South Wales, Australia, 2065
Contact    61299268388      
Principal Investigator: Greg Fulcher         
Australia, Queensland
CORE Research Group Pty Ltd Recruiting
Brisbane, Queensland, Australia, 4064
Contact    61733719477      
Principal Investigator: David Martin Colquhoun         
Australia, South Australia
GP Plus Marion Recruiting
Oaklands Park, South Australia, Australia, 5046
Contact    61874258690      
Principal Investigator: Stephen Stranks         
Australia, Victoria
Eastern Clinical Research Unit Recruiting
Box Hill, Victoria, Australia, 3128
Contact    61398906472      
Principal Investigator: Richard Walter Simpson         
Barwon Health - The Geelong Hospital Recruiting
Geelong, Victoria, Australia, 3220
Contact    61342152880      
Principal Investigator: Shannon McCarthy         
Royal Melbourne Hospital Recruiting
Parkville, Victoria, Australia, 3050
Contact    61293427428      
Principal Investigator: Peter G Colman         
Australia, Western Australia
Fremantle Hospital Recruiting
Fremantle, Western Australia, Australia, 6160
Contact    61894313228      
Principal Investigator: Timothy Davis         
Brazil
Instituto de Ensino e Pesquisa Clinica do Ceara Not yet recruiting
Fortaleza, Ceara, Brazil, 60170-195
Contact    558532579646      
Principal Investigator: Maria José Araujo Gomes Cerqueira         
Centro de Pesquisa Clinica do Brasil Not yet recruiting
Brasilia, Distrito Federal, Brazil, 71625-009
Contact    556133643364      
Principal Investigator: Joao L C Borges         
Cedoes Centro Diagnostico Pequisa Osteoporose E Santo Ltd Not yet recruiting
Vitoria, Espirito Santo, Brazil, 29055-450
Contact    552721250220      
Principal Investigator: Camila Pitanga Calil Salim         
Centro de Diabetes Curitiba Not yet recruiting
Curitiba, Parana, Brazil, 80810-040
Contact    554130231252      
Principal Investigator: Luciana Muniz Pechmann         
CCBR Brasil Centro de Analises e Pesquisas Clínicas LTDA Not yet recruiting
Rio de Janeiro, RJ, Brazil, 22271-100
Contact    552125277979      
Principal Investigator: Luis Russo         
Cpclin Centro de Pesquisas Clinicas Not yet recruiting
Sao Paulo, São Paulo, Brazil, 01244-030
Contact    551127110251      
Principal Investigator: Denise R Franco         
Centro de Pesq. em Diabetes e Doencas Endocrino Metabol. Not yet recruiting
Fortaleza, Brazil, 60430-350
Contact    558530327044      
Principal Investigator: Miguel Nasser Hissa         
Dr. Consulta Clínica Médica LTDA Recruiting
São Paulo, Brazil, 01141-020
Contact    551140901510      
Principal Investigator: Tatiana Franco Hirakawa         
CPQuali Pesquisa Clínica Ltda. Not yet recruiting
São Paulo, Brazil, 01228-000
Contact    551127766801      
Principal Investigator: Gustavo Akerman Augusto         
Canada, Alberta
LMC Manna Research Not yet recruiting
Calgary, Alberta, Canada, T2H 2G4
Contact    4032883224      
Principal Investigator: Buki Ajala         
C-Health Diabetes and Endocrinology Clinic Calgary Not yet recruiting
Calgary, Alberta, Canada, T2V 4J2
Contact    4037053636      
Principal Investigator: Sue Pedersen         
Canada, Ontario
LMC Endocrinology Centres Ltd. Recruiting
Barrie, Ontario, Canada, L4N 7L3
Contact    7057370830      
Principal Investigator: Hani Ghalib Mohammed Al-Assad         
LMC Endocrinology Centers Brampton Recruiting
Brampton, Ontario, Canada, L6S 0C6
Contact    9055950560      
Principal Investigator: Harpreet Bajaj         
Aggarwal and Associates Ltd Recruiting
Brampton, Ontario, Canada, L6T 0G1
Contact    9054589033      
Principal Investigator: Naresh Kumar Aggarwal         
LMC Endocrinology Centres Ltd. Recruiting
Concord, Ontario, Canada, L4K 4M2
Contact    9057638660      
Principal Investigator: Ronald M Goldenberg         
LMC Endocrinology Centres Ltd. Recruiting
Nepean, Ontario, Canada, K2J 0V2
Contact    6135059704      
Principal Investigator: Chetna Tailor         
Manna Research, Inc. Recruiting
Stoney Creek, Ontario, Canada, L8J 3W2
Contact    4162940724      
Principal Investigator: Sudip Datta         
LMC Endocrinology Centres Ltd. Recruiting
Toronto, Ontario, Canada, M4G 3E8
Contact    4166452929      
Principal Investigator: Oren Steen         
Sameh Fikry Medicine Professional Corporation Recruiting
Waterloo, Ontario, Canada, N2J 1C4
Contact    5195697592      
Principal Investigator: Fadia El Boreky         
Canada, Quebec
Q & T Research Outaouais Recruiting
Gatineau, Quebec, Canada, J8Y 6S8
Contact    8197777890      
Principal Investigator: Eric St-Amour         
Manna Research (Quebec) Recruiting
Levis, Quebec, Canada, G6W OM5
Contact    4188398572      
Principal Investigator: Francois Blouin         
LMC Endocrinology Centres Ltd. Recruiting
Montreal, Quebec, Canada, H4A 2C6
Contact    4388024526      
Principal Investigator: Jean Francois Yale         
LMC Endocrinology Centres Ltd. Recruiting
Ville St-Laurent, Quebec, Canada, H4T 1Z9
Contact    5147445620      
Principal Investigator: Zeina Yared         
Greece
Iatriko Palaiou Falirou, Medical Center Not yet recruiting
Palaio Faliro, Athens, Greece, 17562
Principal Investigator: Ioannis Doupis         
Thermi Clinic Not yet recruiting
Thermi, Thessaloniki, Greece, 57001
Principal Investigator: Emmanouil Pagkalos         
University General Hospital of Larissa Not yet recruiting
Larissa, Greece, 41110
Principal Investigator: Alexandra Bargiota         
AHEPA Hospital Not yet recruiting
Thessaloniki, Greece, 54636
Contact    3031993111      
Principal Investigator: Kalliopi Kotsa         
Euromedica - General Clinic of Thessaloniki Not yet recruiting
Thessaloniki, Greece, 54645
Contact    +302310895100      
Principal Investigator: Zadalla Mouslech         
Israel
Ha'Emek Medical Center Not yet recruiting
Afula, Israel, 1834111
Contact    97246495556      
Principal Investigator: Avraham Ishay         
Soroka Medical Center Not yet recruiting
Beer Sheva, Israel, 8410101
Contact    97286400583      
Principal Investigator: Idit Liberty         
Rambam Medical Center Not yet recruiting
Haifa, Israel, 3109601
Contact    97249016300      
Principal Investigator: Naim Shehadeh         
Wolfson Medical Center Recruiting
Holon, Israel, 5822012
Contact    97235028716      
Principal Investigator: Julio Wainstein         
Hadassah Medical Center Not yet recruiting
Jerusalem, Israel, 911201
Contact    97226776927      
Principal Investigator: Ofri Mosenzon         
Meir Medical Center Not yet recruiting
Kfar Saba, Israel, 4428164
Contact    97297472559      
Principal Investigator: Victor Vishlitzky         
Rabin Medical Center Not yet recruiting
Petach Tikva, Israel, 4941492
Contact    039377182      
Principal Investigator: Ilan Shimon         
Sheba Medical Center Recruiting
Ramat Gan, Israel, 5266202
Contact    97235302802      
Principal Investigator: Amir Tirosh         
Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv Jaffa, Israel, 6423906
Contact    036973732      
Principal Investigator: Naftali Stern         
Mexico
Instituto Jalisciense de Investigacion en Diabetes y Obesida Recruiting
Guadalajara, Jalisco, Mexico, 04460
Contact    523311991124      
Principal Investigator: Guillermo Gonzalez Galvez         
Diseno y Planeacion en Investigacion Medica S.C. Recruiting
Guadalajara, Jalisco, Mexico, 44130
Contact    52333306212      
Principal Investigator: Cesar Gonzalo Calvo Vargas         
St. Lucas Clinical Research Center Recruiting
Merida, Mexico State, Mexico, 97217
Contact    529994610519      
Principal Investigator: Ruy David Arjona         
Unidad Medica para la Salud Integral (UMSI) Recruiting
Monterrey, Nuevo León, Mexico, 66465
Contact    528183488973      
Principal Investigator: Ramiro Banda         
Centro de Estudios de Investigacion Metabolicos y Cardiovasc Recruiting
Tampico, Tamaulipas, Mexico, 89000
Contact    528332142554      
Principal Investigator: Rafael M Violante Ortiz         
Investigacion en Salud y Metabolismo S.C Recruiting
Chihuahua, Mexico, 31217
Contact    526144398618      
Principal Investigator: Luis A Nevarez         
Poland
Poradnia Diabetologiczna SN ZOZ Lege Artis Not yet recruiting
Bialystok, Poland, 15-404
Contact    48856545520      
Principal Investigator: Anna Modzelewska         
NZOZ Diab-Endo-Met Not yet recruiting
Krakow, Poland, 31-261
Contact    48126237122      
Principal Investigator: Andrzej Stankiewicz         
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. Not yet recruiting
Lodz, Poland, 90-242
Contact    48422300609      
Principal Investigator: Malgorzata Jozefowska         
Gabinety Terpa Not yet recruiting
Lublin, Poland, 20-333
Contact    48814427272      
Principal Investigator: Beata Matyjaszek-Matuszek         
NZOZ Przychodnia Specjalistyczna MEDICA Not yet recruiting
Lublin, Poland, 20-538
Contact    48815268441      
Principal Investigator: Ewa Skokowska         
Praktyka Lekarska Not yet recruiting
Poznan, Poland, 61-655
Contact    48504211981      
Principal Investigator: Ewa Krzyzagorska         
Nzoz Neuro - Kard Not yet recruiting
Poznan, Poland, 61-853
Principal Investigator: Andrzej Koscianski         
NZOZ Przychodnia Specjalistyczna Henryk RudzkiAndrzej Wittek Not yet recruiting
Ruda Slaska, Poland, 41-709
Contact    48322442300      
Principal Investigator: Henryk Rudzki         
Centralny Szpital Kliniczny MSW Not yet recruiting
Warszawa, Poland, 02-507
Contact    48226021300      
Principal Investigator: Edward Franek         
Woj. Zesp. Spec. Opieki Zdrowotnej Not yet recruiting
Wroclaw, Poland, 50-403
Contact    48717747700      
Principal Investigator: Dariusz Sowinski         
Puerto Rico
Emanuelli Research & Development Center, LLC Recruiting
Arecibo, Puerto Rico, 00612
Contact    7878897722      
Principal Investigator: Luis Hernandez-Vazquez         
Manati Center for Clinical Research Inc Recruiting
Manati, Puerto Rico, 00674
Contact    7879047700      
Principal Investigator: Ramon Ortiz-Carrasquillo         
Ponce School of Medicine CAIMED Center Recruiting
Ponce, Puerto Rico, 00716
Contact    7878402505      
Principal Investigator: Elizabeth A Barranco-Santana         
Research and Cardiovascular Corp. Recruiting
Ponce, Puerto Rico, 00717
Contact    7872908585      
Principal Investigator: Jose B Vazquez-Tanus         
University Of Puerto Rico Not yet recruiting
Rio Pedras, Puerto Rico, 00935
Contact    7877590306      
Principal Investigator: Rafael Burgos Calderon         
GCM Medical Group PSC Recruiting
San Juan, Puerto Rico, 00909
Contact    7877268396      
Principal Investigator: Gregorio A. Cortes-Maisonet         
Consultorio Medico Not yet recruiting
San Juan, Puerto Rico, 00921
Contact    7877925566      
Principal Investigator: Luis A Rivera Colon         
Romania
SC Gama Diamed SRL Recruiting
Mangalia, Constanta, Romania, 905500
Contact    40241740581      
Principal Investigator: Amalia Thury-Burileanu         
Spitalul Judetean de Urgenta Satu Mare Not yet recruiting
Satu-Mare, Jud Satu-Mare, Romania, 440055
Contact    40261712849      
Principal Investigator: Iosif Szilagyi         
CMI DNBM Dr. Pop Lavinia Not yet recruiting
Baia Mare, Maramures, Romania, 430222
Contact    40362803230      
Principal Investigator: Lavinia Pop         
Cosamext SRL Not yet recruiting
Targu Mures, Mures, Romania, 540098
Contact    40265435422      
Principal Investigator: Daniela Ciomos         
SC Diabmed Dr Popescu Alexandrina SRL Recruiting
Ploiesti, Prahova, Romania, 100163
Contact    40244523484      
Principal Investigator: Alexandrina Popescu         
Centrul Medical Dr. Negrisanu Not yet recruiting
Timisoara, Timis, Romania, 300456
Contact    40256240609      
Principal Investigator: Gabriela Doina Negrisanu         
SC CMI Dr. Pletea Noemi SRL Not yet recruiting
Bacau, Romania, 600154
Contact    40234546915      
Principal Investigator: Noemi Nicoleta Pletea         
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL Not yet recruiting
Brasov, Romania, 500283
Contact    40368424168      
Principal Investigator: Valentina Neacsu         
Cabinetul Medical Nicodiab SRL Not yet recruiting
Bucharest, Romania, 010507
Contact    40212116046      
Principal Investigator: Nicoleta Mihaela Mindrescu         
SC Nutrilife SRL Recruiting
Bucuresti, Romania, 013682
Contact    40212323445      
Principal Investigator: Marlena Pascu         
Cabinet Medical Urodiamed S.R.L. Not yet recruiting
Craiova, Romania, 200349
Contact    40251510384      
Principal Investigator: Camelia Panus         
Milena Sante SRL Not yet recruiting
Galati, Romania, 800001
Contact    40236464546      
Principal Investigator: Cristina Mistodie         
Russian Federation
Arkhangelsk the first city clinical hospital Not yet recruiting
Arkhangelsk, Russian Federation, 163045
Contact    78182632996      
Principal Investigator: Irina Dvoryashina         
FSBI Endocrinological Research Center of the MOH of the ROF Not yet recruiting
Moscow, Russian Federation, 117036
Contact    74957190932      
Principal Investigator: GAGIK GALSTYAN         
City Hospital of Saint Martyr Elizabeth Not yet recruiting
Saint Petersburg, Russian Federation, 193257
Contact    78129872913      
Principal Investigator: Natalia V. Vorokhobina         
Medical Military Academy Not yet recruiting
Saint Petersburg, Russian Federation, 194044
Contact    78125426201      
Principal Investigator: Yury Khalimov         
SPb GUZ "Diagnostic Center #85" Not yet recruiting
Saint Petersburg, Russian Federation, 198255
Contact    78127521371      
Principal Investigator: Olga A Miroshnichenko         
City Consultative and Diagnostic Center Not yet recruiting
Saint-Petersburg, Russian Federation, 194354
Contact    78122963605      
Principal Investigator: Irina Karpova         
Regional Clinical Hospital Not yet recruiting
Saratov, Russian Federation, 410053
Contact    78452491454      
Principal Investigator: Marina Kunitsyna         
Slovakia
Human care s.r.o. Not yet recruiting
Kosice, Slovak Republic, Slovakia, 04012
Contact    421556802410      
Principal Investigator: Viera Donicova         
MediVet s.r.o. Not yet recruiting
Malacky, Slovak Republic, Slovakia, 90101
Contact    421347723225      
Principal Investigator: Eva Pavleova         
Areteus s.r.o. Not yet recruiting
Trebisov, Slovak Republic, Slovakia, 07501
Contact    421903603981      
Principal Investigator: Dasa Skripova         
DIA-MED CENTRUM s.r.o. Not yet recruiting
Puchov, Slovakia, 02001
Contact    421424605326      
Principal Investigator: Ludmila Kubincova         
Tatratrial s.r.o. Not yet recruiting
Roznava, Slovakia, 04801
Contact    421587329625      
Principal Investigator: Dalibor Sosovec         
MEDI-DIA s.r.o. Not yet recruiting
Sabinov, Slovakia, 08301
Contact    421917174804      
Principal Investigator: Martina Merciakova         
Spain
Hospital Universitario Marques De Valdecilla Not yet recruiting
Santander, Cantabria, Spain, 39011
Principal Investigator: Luis Vazquez         
Hospital Universitario Quiron Madrid Not yet recruiting
Pozuelo de Alarcon, Madrid, Spain, 28223
Principal Investigator: Esteban Jodar Gimeno         
Instituto de Ciencias medicas Not yet recruiting
Alicante, Spain, 03004
Principal Investigator: Luis de Teresa Parreño         
Clinica San Pedro Not yet recruiting
Almeria, Spain, 04001
Principal Investigator: Pedro Mezquita Raya         
Hospital Quironsalud Barcelona- END Not yet recruiting
Barcelona, Spain, 08023
Principal Investigator: Fernando Cereto         
Hospital Clinico Universitario San Cecilio Not yet recruiting
Granada, Spain, 18012
Principal Investigator: Miguel Quesada Charneco         
Centro Especialidades San Jose Obrero (Barbarela) Not yet recruiting
Malaga, Spain, 29006
Principal Investigator: Francisco Tinahones Madueño         
Clinica Juaneda Not yet recruiting
Palma de Mallorca, Spain, 07014
Principal Investigator: Santiago Tofe Povedano         
Hospital Universitario Virgen Macarena Not yet recruiting
Sevilla, Spain, 41009
Contact    34955693429      
Principal Investigator: Cristobal Morales         
Clinica Nuevas Tecnologias en Diabetes y Endocrinologia Not yet recruiting
Seville, Spain, 41003
Principal Investigator: Maria Del Carmen Cuesta Mayor         
Taiwan
Cardinal Tien Hospital Recruiting
Sindian City, Taipei County, Taiwan, 23148
Contact    886222193391 ext.66802      
Principal Investigator: Te-Lin Hsia         
Chang Gung Memorial Hospital - Kaohsiung Not yet recruiting
Kaohsiung City, Taiwan, 833
Contact    88677317123 ext. 3035      
Principal Investigator: Jung-Fu Chen         
Chung Shan Medical University Hospital Recruiting
Taichung City, Taiwan, 40201
Contact    886424739595 ext.34111      
Principal Investigator: Chien-Ning Huang         
Kuang Tien General Hospital Not yet recruiting
Taichung County, Taiwan, 433
Contact    886426625111 ext.2189      
Principal Investigator: Shih-Ting Tseng         
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
Contact    886422052121 ext.2010      
Principal Investigator: Ching-Chu Chen         
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, 704
Contact    88662353535 ext 4577      
Principal Investigator: Horng-Yih Ou         
National Taiwan University Hospital Recruiting
Taipei City, Taiwan, 10048
Contact    886223123456 ext. 65038      
Principal Investigator: Lee-Ming Chuang         
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Contact    886228757516      
Principal Investigator: Chii-Min Hwu         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03730662     History of Changes
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: February 19, 2019
Last Verified: February 1, 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

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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs