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A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes (SURPASS-2)

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: NCT03987919
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The reason for this study is to compare the effect of the study drug tirzepatide to semaglutide on blood sugar levels in participants with type 2 diabetes. The study will last approximately 47 weeks and may include about 12 visits.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Tirzepatide Drug: Semaglutide Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1872 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of Tirzepatide Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
Actual Study Start Date : July 30, 2019
Estimated Primary Completion Date : March 23, 2021
Estimated Study Completion Date : April 23, 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: Semaglutide
Semaglutide administered SC once a week.
Drug: Semaglutide
Administered SC




Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) [ Time Frame: Baseline, Week 40 ]
    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 40 ]
    Change from Baseline in HbA1c

  2. Change from Baseline in Body Weight [ Time Frame: Baseline, Week 40 ]
    Change from Baseline in Body Weight

  3. Percentage of Participants Achieving an HbA1c Target Value of <7% [ Time Frame: Week 40 ]
    Percentage of Participants Achieving an HbA1c Target Value of <7%

  4. Change from Baseline in Fasting Serum Glucose [ Time Frame: Baseline, Week 40 ]
    Change from Baseline in Fasting Serum Glucose

  5. Mean Change from Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values [ Time Frame: Baseline, Week 40 ]
    Mean Change from Baseline in Daily Average 7-Point SMBG Values

  6. Percentage of Participants who Achieved Weight Loss ≥5% [ Time Frame: Week 40 ]
    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 40 ]
    Change from Baseline in Diabetes Treatment Satisfaction as Measured by the DTSQ

  8. Rate of Documented Symptomatic Hypoglycemic Episodes [ Time Frame: Baseline through Week 40 ]
    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:

  • 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 >1500 mg/day for at least 3 months prior to screening
  • Be of stable weight (±5%) for at least 3 months before screening
  • Have a body mass index (BMI) ≥25 kilograms per meter squared (kg/m²) at screening

Exclusion Criteria:

  • 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 milliliters/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 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): NCT03987919


Contacts
Layout table for location 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
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United States, Alabama
Cahaba Research Recruiting
Birmingham, Alabama, United States, 35242
Contact    205-408-4134      
Principal Investigator: Jordan Vaughn         
Syed Research Consultants, LLC Recruiting
Sheffield, Alabama, United States, 35660
Contact    256-383-4473      
Principal Investigator: Faizullah Syed         
United States, California
National Research Institute Recruiting
Huntington Park, California, United States, 90255
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    213-413-2500      
Principal Investigator: Robert A Jenders         
Artemis Institute for Clinical Research Recruiting
Riverside, California, United States, 92503
Contact    951-374-1190      
Principal Investigator: Sarah Lavery         
Artemis Institute for Clinical Research Recruiting
San Diego, California, United States, 92103
Contact    858-278-3674      
Principal Investigator: Purvi Mehra         
Artemis Institute for Clinical Research Recruiting
San Marcos, California, United States, 92078
Contact    760-266-4144      
Principal Investigator: Stacey L Layle         
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
Hamden, Connecticut, United States, 06517
Contact    203-419-4420      
Principal Investigator: Joseph Soufer         
United States, Florida
Clinical Research of South Florida Recruiting
Coral Gables, Florida, United States, 33134
Contact    305-445-5637      
Principal Investigator: Jeffrey B Rosen         
East Coast Institute For Research Recruiting
Lake City, Florida, United States, 32055
Contact    386-868-5625      
Principal Investigator: Minesh Patel         
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, 33165
Principal Investigator: Lazaro Nunez         
Oviedo Medical Research Recruiting
Oviedo, Florida, United States, 32765
Contact    407-977-2705      
Principal Investigator: Bradley M. Block         
South Broward Research LLC Recruiting
Pembroke Pines, Florida, United States, 33027
Contact    954-433-5867      
Principal Investigator: Kenneth Blaze         
United States, Georgia
United Osteoporosis Center Recruiting
Gainesville, Georgia, United States, 30501
Contact    770-534-5154      
Principal Investigator: Christopher P. Recknor         
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         
United States, Iowa
University of Iowa Hospital & Clinic Recruiting
Iowa City, Iowa, United States, 52242
Contact    319-384-9620      
Principal Investigator: Jennifer G. Robinson         
United States, Kansas
Cotton O'Neil Clinic Recruiting
Topeka, Kansas, United States, 66606
Contact    785-354-9591      
Principal Investigator: Michael Cox         
Cotton O'Neil Diabetes and Endocrinology Center Recruiting
Topeka, Kansas, United States, 66606
Contact    785-368-0491      
Principal Investigator: Alan G Wynne         
United States, Massachusetts
NECCR PrimaCare Research, LLC Recruiting
Fall River, Massachusetts, United States, 02721
Contact    508-679-6611      
Principal Investigator: Ehab Sorial         
ActivMed Practices & Research, Inc Recruiting
Methuen, Massachusetts, United States, 01844
Contact    978-927-5254      
Principal Investigator: Michael J McCartney         
United States, Mississippi
Olive Branch Family Medical Center Recruiting
Olive Branch, Mississippi, United States, 38654
Contact    662-893-8474      
Principal Investigator: Randall Huling         
United States, Missouri
ClinVest Recruiting
Springfield, Missouri, United States, 65810
Contact    417-883-7889      
Principal Investigator: David G. True         
United States, New Jersey
Premier Research Recruiting
Trenton, New Jersey, United States, 08611
Contact    609-392-6666      
Principal Investigator: Jane L Rohlf         
United States, New York
Endocrine Group, LLP Recruiting
Albany, New York, United States, 12206
Contact    518-461-9734      
Principal Investigator: Robert Busch         
United States, North Carolina
PharmQuest Recruiting
Greensboro, North Carolina, United States, 27408
Contact    336-574-8020      
Principal Investigator: Alexander V. Murray         
Diabetes & Endocrinology Consultants PC Recruiting
Morehead City, North Carolina, United States, 28557
Contact    2522225700      
Principal Investigator: Kathryn Jean Lucas         
PMG Research of Wilmington, LLC Recruiting
Wilmington, North Carolina, United States, 28401
Contact    910-815-6108      
Principal Investigator: John C Parker         
United States, North Dakota
Lillestol Research LLC Recruiting
Fargo, North Dakota, United States, 58104
Contact    701-232-7705      
Principal Investigator: Michael Lillestol         
United States, Ohio
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, Pennsylvania
Heritage Valley Medical Group, Inc. Recruiting
Beaver, Pennsylvania, United States, 15009
Contact    724-774-7743      
Principal Investigator: Michael J Oliver         
Capital Area Research Recruiting
Camp Hill, Pennsylvania, United States, 17011
Contact    717-441-1725      
Principal Investigator: Venkatesh Nadar         
Detweiler Family Medicine Recruiting
Lansdale, Pennsylvania, United States, 19446
Contact    215-368-1900      
Principal Investigator: Evan Kessler         
Green & Seidner Family Practice Associates PC Recruiting
Lansdale, Pennsylvania, United States, 19446
Contact    215-361-7164      
Principal Investigator: Jack C Rosenfeld         
Thomas Jefferson University Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact    215-955-1925      
Principal Investigator: Serge Jabbour         
Preferred Primary Care Physicians- Bower Hill Recruiting
Pittsburgh, Pennsylvania, United States, 15243
Contact    412-942-0023      
Principal Investigator: Raman Purighalla         
United States, Tennessee
Holston Medical Group Recruiting
Bristol, Tennessee, United States, 37620
Contact    423-990-2478      
Principal Investigator: Andrew Brockmyre         
United States, Texas
Dallas Diabetes Endocrine Center Recruiting
Dallas, Texas, United States, 75230
Contact    972-566-7799      
Principal Investigator: Julio Rosenstock         
Biopharma Informatic, Inc. Recruiting
Houston, Texas, United States, 77043
Contact    281-768-5879      
Principal Investigator: Donald F Gardner         
Consano Clinical Research Recruiting
Shavano Park, Texas, United States, 78231
Contact    210-545-4900      
Principal Investigator: Michelle Welch         
Carl R. Meisner Medical Clinic, PLLC Recruiting
Sugar Land, Texas, United States, 77478
Contact    8325005184      
Principal Investigator: Carl Roger Meisner         
Martin Diagnostic Clinic Recruiting
Tomball, Texas, United States, 77375
Contact    281-517-0550      
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
Capital Clinical Research Center Recruiting
Olympia, Washington, United States, 98502
Contact    360-786-0692      
Principal Investigator: Eric J. Klein         
Vancouver Clinic Recruiting
Vancouver, Washington, United States, 98664
Contact    360-253-3294      
Principal Investigator: Stacey Condren         
Argentina
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 Medico Dr Laura Maffei Investigacion Clinica Aplicada Recruiting
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1425AGC
Contact    541148019001      
Principal Investigator: Maria Jimena Coronel         
Mautalen Salud e Investigacion-Centro de Osteopatías Médicas Recruiting
Ciudad Autonoma De Buenos Air, Buenos Aires, Argentina, C1128AAF
Contact    541145143400      
Principal Investigator: Jose Osvaldo Fretes         
Centro de Investigacion y Prevencion Cardiovascular (CIPREC) Recruiting
Ciudad Autonoma de, Buenos Aires, Argentina, C1119ACN
Contact    5491144074402      
Principal Investigator: Cesar Javier Zaidman         
Instituto de Investigaciones Clinicas Mar del Plata Recruiting
Mar del Plata, Buenos Aires, Argentina, B7600FZN
Contact    542234963224      
Principal Investigator: Ignacio Mackinnon         
CIPADI Not yet recruiting
Godoy Cruz, Mendoza, Argentina, M5501ARP
Contact    542614200345      
Principal Investigator: Pedro Calella         
AXISMED SRL - Bioclinica Research Network Not yet recruiting
Buenos Aires, Argentina, C1430CKE
Contact    5491159465095      
Principal Investigator: Jorge Glenny         
Centro de Investigaciones Metabólicas (CINME) - Comite Recruiting
Ciudad Autonoma Buenos Aires, Argentina, C1056ABJ
Contact    541150319914      
Principal Investigator: Federico Perez Manghi         
Centro Médico Viamonte Recruiting
Ciudad Autonoma de Buenos Aire, Argentina, C1120AAC
Contact    541149635650      
Principal Investigator: Diego Aizenberg         
Instituto Centenario Recruiting
Ciudad Autonoma de Buenos Aire, Argentina, C1204AAD
Contact    5491140783327      
Principal Investigator: Susana Salzberg         
Cemediab - Centro Médico Diabetológico Dr. Alejandro Chertkoff Recruiting
Ciudad Autonoma de Buenos Aire, Argentina, C1205AAO
Contact    541149815688      
Principal Investigator: Alejandro Chertkoff         
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC Recruiting
Cordoba, Argentina, X5008HHW
Contact    5403514766837      
Principal Investigator: Lucrecia Nardone         
Sanatorio Norte Recruiting
Santiago del Estero, Argentina, 4200
Contact    0384154125573      
Principal Investigator: Franklin Hector Abalos         
Australia, New South Wales
Paratus Clinical Blacktown Clinic Recruiting
Blacktown, New South Wales, Australia, 2148
Contact    0419667015      
Principal Investigator: Christopher Argent         
Campbelltown Medical & Dental Centre Recruiting
Campbelltown, New South Wales, Australia, 2560
Contact    0246283777      
Principal Investigator: Nathan Dong Zhou         
Paratus Clinical Kanwal Clinic Recruiting
Kanwal, New South Wales, Australia, 2259
Contact    610413050782      
Principal Investigator: James Vandeleur         
Holdsworth House Medical Practice Recruiting
Sydney, New South Wales, Australia, 2010
Contact    61293317228      
Principal Investigator: Mark Bloch         
Australia, Queensland
GenesisCare - Bundaberg Recruiting
Bundaberg, Queensland, Australia, 4670
Contact    0422353853      
Principal Investigator: David Di Fiore         
Royal Brisbane and Womens Hospital Recruiting
Herston, Queensland, Australia, 4029
Contact    61736467780      
Principal Investigator: Michael D'Emden         
CORE Research Group Pty Ltd Recruiting
Milton, Queensland, Australia, 4064
Contact    61738765688      
Principal Investigator: David Martin Colquhoun         
AusTrials Pty Ltd Recruiting
Sherwood, Queensland, Australia, 4075
Contact    61732785255      
Principal Investigator: Fred Johan De Looze         
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    61352267450      
Principal Investigator: Shannon McCarthy         
Australia, Western Australia
GenesisCare Recruiting
Joondalup, Western Australia, Australia, 6027
Principal Investigator: Peter Walter Purnell         
GenesisCare Wexford Recruiting
Murdoch, Western Australia, Australia, 6150
Contact    61413010794      
Principal Investigator: Peter Walter Purnell         
Australia
Adelaide Medical Solutions Recruiting
Woodville South, Australia, 5011
Contact    61411100278      
Principal Investigator: Sepehr Shakib         
Brazil
Cedoes Centro Diagnostico Pequisa Osteoporose E Santo Ltd Not yet recruiting
Vitoria, ES, Brazil, 29055 450
Contact    552732351405      
Principal Investigator: Camila Pitanga Calil Salim         
Centro de Pesquisas em Diabetes Not yet recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90430-001
Contact    555137796400      
Principal Investigator: Luis Henrique S Canani         
CPQuali Pesquisa Clínica Ltda. Not yet recruiting
São Paulo, SP, Brazil, 01228-000
Contact    551127766801      
Principal Investigator: Gustavo Akerman Augusto         
Cpclin Centro de Pesquisas Clinicas Not yet recruiting
São Paulo, SP, Brazil, 01228-200
Contact    55 11 2711 0251      
Principal Investigator: Denise R Franco         
CEPIC-Centro Paulista de Investigacao Clinica Not yet recruiting
São Paulo, SP, Brazil, 04266-010
Contact    551122713452      
Principal Investigator: Luana Casari da Silva Lima         
ISPEM - Instituto São José dos Campos em Pesquisas Médicas Not yet recruiting
São José dos Campos, Brazil, 12243-280
Contact    12981550036      
Principal Investigator: Antonio D Pereira         
Dr. Consulta Clínica Médica LTDA Not yet recruiting
São Paulo, Brazil, 01141-020
Contact    5511999030078      
Principal Investigator: Tatiana Franco Hirakawa         
Canada, Ontario
Manna Research, Inc. Recruiting
Burlington, Ontario, Canada, L7M 4Y1
Contact    9055922262      
Principal Investigator: Huma Numair         
Milestone Research Inc. Recruiting
London, Ontario, Canada, N5W6A2
Contact    5196594040      
Principal Investigator: Peter Dzongowski         
Manna Research, Inc. Recruiting
Nepean, Ontario, Canada, K2J 4A7
Contact    6138431718      
Principal Investigator: Roozbeh Matin         
Bluewater Clinical Research Group Inc Recruiting
Sarnia, Ontario, Canada, N7T 4X3
Contact    5193446612      
Principal Investigator: John O'Mahony         
Manna Research, Inc. Recruiting
Stoney Creek, Ontario, Canada, L8J 3W2
Contact    4162940724      
Principal Investigator: Mehul Patel         
Dr. Anil K. Gupta Medicine Professional Corporation Recruiting
Toronto, Ontario, Canada, M9V 4B4
Contact    4167411500      
Principal Investigator: Anil Gupta         
Manna Research, Inc. Recruiting
Toronto, Ontario, Canada, M9W 4L6
Contact    4167402895      
Principal Investigator: Azhar Munir Toma         
Canada, Quebec
Manna Research (Quebec) Recruiting
Levis, Quebec, Canada, G6W 0M5
Contact    4188398572      
Principal Investigator: Francois Blouin         
Israel
Meir Medical Center Ethics Committee Recruiting
Kfar Saba, HaMerkaz, Israel, 4428164
Contact    972506264997      
Principal Investigator: Victor Vishlitzky         
Clalit Health Services - Shuali Clinic Recruiting
Raanana, HaMerkaz, Israel, 43405
Contact    972544510335      
Principal Investigator: Adiv Goldhaber         
Sheba Medical Center Recruiting
Ramat Gan, HaMerkaz, Israel, 5262100
Contact    972526666777      
Principal Investigator: Amir Tirosh         
Hadassah Medical Center Recruiting
Jerusalem, Yerushalayim, Israel, 9112001
Contact    972546883360      
Principal Investigator: Ofri Mosenzon         
Sakhnin Community Clinic, Clalit Health Services Recruiting
Sakhnin, Israel, 3081000
Contact    972544719456      
Principal Investigator: Mahmud Darawsha         
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv Jaffa, Israel, 6423906
Contact    97236973415      
Principal Investigator: Yael Sofer         
Diabetes Medical Center (DMC) Not yet recruiting
Tel Aviv, Israel, 6148002
Contact    9720506296940      
Principal Investigator: Julio Wainstein         
Rambam Health Care Campus Not yet recruiting
Haifa, Ḥeifā, Israel, 3109601
Contact    97247771606      
Principal Investigator: Naim Shehadeh         
Linn Medical Center Recruiting
Haifa, Ḥeifā, Israel, 3515209
Contact    97248568685      
Principal Investigator: Muhammad Sabbah         
Mexico
Centro Especializado en Diabetes Obesidad y Enfermedades Recruiting
Mexico, D.f., Mexico, 11650
Contact    525552824343      
Principal Investigator: Melchor Alpizar         
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    523333306212      
Principal Investigator: Cesar Gonzalo Calvo Vargas         
Unidad de Investigacion Clinica Recruiting
Guadalajara, Jalisco, Mexico, 44150
Contact    3331706956      
Principal Investigator: Maricela Vidrio         
Hospital Universitario Dr. Jose Eleuterio Gonzalez Not yet recruiting
Monterrey, N.l., Mexico, 64460
Contact    528183482015      
Principal Investigator: Pedro Alberto Garcia Hernandez         
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
Madero, Tamaulipas, Mexico, 89440
Contact    00528331260055      
Principal Investigator: Rafael M Violante Ortiz         
Centro de Investigacion Clinica Recruiting
Chihuahua, Mexico, 31238
Contact    526144392700      
Principal Investigator: Luis A Nevarez         
Puerto Rico
Paola Mansilla-Letelier, MD Recruiting
Guaynabo, Puerto Rico, 00970
Contact    7874000333      
Principal Investigator: Paola Mansilla-Letelier         
Ararat Research Center Recruiting
Ponce, Puerto Rico, 007171563
Contact    7872845884      
Principal Investigator: Ivan Melendez-Rivera         
Research and Cardiovascular Corp. Recruiting
Ponce, Puerto Rico, 00717
Contact    7872908585      
Principal Investigator: Jose B Vazquez-Tanus         
Clinical Research Puerto Rico, Inc. Recruiting
San Juan, Puerto Rico, 00909
Contact    7877235945      
Principal Investigator: Miguel Sosa-Padilla         
Martha Gomez Cuellar M.D. Recruiting
San Juan, Puerto Rico, 00921
Contact    7874842757      
Principal Investigator: Martha Gomez Cuellar         
United Kingdom
Oldfield Surgery Recruiting
Bath, Avon, United Kingdom, BA2 3HT
Contact    441225421137      
Principal Investigator: Timothy Johnson         
The Staploe Medical Centre Recruiting
Ely, Cambridgeshire, United Kingdom
Contact    07711326129      
Principal Investigator: Anthony Gunstone         
Fowey River Practice Recruiting
Fowey, Cornwall, United Kingdom, PL23 1DT
Contact    01726832451      
Principal Investigator: Paula-Jane Marrett         
Oak Tree Surgery Recruiting
Liskeard, Cornwall, United Kingdom, PL14 3XA
Contact    441579324252      
Principal Investigator: Rehan Symonds         
Rame Medical Ltd Recruiting
Torpoint, Cornwall, United Kingdom, PL 11 2TB
Contact    00441752817900      
Principal Investigator: Lawrence Barnes         
Ashgate Medical Practice Recruiting
Chesterfield, Derbyshire, United Kingdom, S40 4AA
Contact    01246 554835      
Principal Investigator: Mark Blagden         
Knowle House Surgery Recruiting
Plymouth, Devon, United Kingdom, PL5 3JB
Contact    01752705090      
Principal Investigator: TIMOTHY HALL         
Queen Alexandra Hospital Recruiting
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Contact    02392286044      
Principal Investigator: Michael Cummings         
Lister Hospital Recruiting
Stevenage, Herts, United Kingdom, SG1 4AB
Contact    +44 1438 314 333 (x4435)      
Principal Investigator: Adie Viljoen         
Oakenhurst Medical Practice Recruiting
Blackburn, Lancashire, United Kingdom, BB2 1AX
Contact    01254617101      
Principal Investigator: Amar Ali         
Leicester General Hospital Not yet recruiting
Leicester, Leicestershire, United Kingdom, LE5 4PW
Contact    01162586481      
Principal Investigator: Melanie J Davies         
University Hospitals Coventry and Warwickshire NHS Trust Recruiting
Coventry, Warwickshire, United Kingdom, CV2 2DX
Contact    02476965249      
Principal Investigator: Harpal Singh Randeva         
Rowden Surgery Recruiting
Chippenham, United Kingdom, SN15 2SB
Contact    07767620210      
Principal Investigator: Richard Dr Gaunt         
Wickersley Health Centre - Clifton Medical Centre Recruiting
Rotherham, United Kingdom, S65 1DA
Contact    08444773622      
Principal Investigator: Matthew Capehorn         
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: NCT03987919     History of Changes
Other Study ID Numbers: 17001
I8F-MC-GPGL ( Other Identifier: Eli Lilly and Company )
2018-004422-29 ( EudraCT Number )
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 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
GLP-1 RA
Glucose-dependent insulinotropic polypeptide (GIP)
glucagon-like peptide-1 (GLP-1)
GIP/GLP-1 dual receptor agonist
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs