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



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:November 20, 2018
End Date:June 15, 2021
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:clinicaltrials.gov@lilly.com
Phone:1-317-615-4559

Use our guide to learn which trials are right for you!

Efficacy and Safety of LY3298176 Once Weekly Versus Insulin Glargine in Patients With Type 2 Diabetes and Increased Cardiovascular Risk (SURPASS-4)

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.


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
We found this trial at
74
sites
Topeka, Kansas 66606
Principal Investigator: Alan G Wynne
Phone: 785-368-0490
?
mi
from
Topeka, KS
Click here to add this to my saved trials
Iowa City, Iowa 52242
Principal Investigator: JENNIFER G. ROBINSON
Phone: 319-384-5030
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
Principal Investigator: Juan P Frias
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
2128 W Flagler St # 201
Miami, Florida 33144
Principal Investigator: Mark E. Kutner
Phone: 305-631-6704
?
mi
from
Miami, FL
Click here to add this to my saved trials
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Andrew J Ahmann
Phone: 503-494-4704
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
?
mi
from
Portland, OR
Click here to add this to my saved trials
500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
Principal Investigator: Joseph Soufer
?
mi
from
Waterbury, CT
Click here to add this to my saved trials
Anaheim, California 92805
Principal Investigator: Patrick Walsh
Phone: 714-999-6688
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Atlanta, Georgia 30312
Principal Investigator: Courtney Shelton
Phone: 678-705-2355
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Beaver, Pennsylvania 15009
Principal Investigator: Michael J Oliver
Phone: 724-774-7743
?
mi
from
Beaver, PA
Click here to add this to my saved trials
Burke, Virginia 22015
Principal Investigator: Nashwa Gabra
Phone: 703-455-9711
?
mi
from
Burke, VA
Click here to add this to my saved trials
Caba, Buenos Aires
Principal Investigator: Elizabeth Gelersztein
Phone: 541148238701
?
mi
from
Caba,
Click here to add this to my saved trials
Camp Hill, Pennsylvania 17011
Principal Investigator: Venkatesh Nadar
Phone: 717-441-1725
?
mi
from
Camp Hill, PA
Click here to add this to my saved trials
Chesterfield, Missouri 63141
Principal Investigator: Timothy W. Jennings
Phone: 636-220-1200
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
Chicago, Illinois 60611
Principal Investigator: Grazia Aleppo
Phone: 312-695-7970
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Clarksville, Tennessee 37040
Principal Investigator: Jacqueline Milam
Phone: 931-245-8444
?
mi
from
Clarksville, TN
Click here to add this to my saved trials
Cleveland, Ohio 44122
Principal Investigator: Toby J Briskin
Phone: 216-682-0320
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Columbus, Ohio 43210
Principal Investigator: Kathleen Dungan
Phone: 614-688-6885
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Columbus, Ohio 43213
Principal Investigator: Samir Arora
Phone: 614-501-6164
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Cooper City, Florida 33024
Principal Investigator: Lorena Lewy-Alterbaum
Phone: 754-263-2000
?
mi
from
Cooper City, FL
Click here to add this to my saved trials
Corvallis, Oregon 97330
Principal Investigator: Michael C Chen
Phone: 541-754-1398
?
mi
from
Corvallis, OR
Click here to add this to my saved trials
Cutler Bay, Florida 33189
Principal Investigator: Miguel Mujica-Baella
Phone: 786-234-3709
?
mi
from
Cutler Bay, FL
Click here to add this to my saved trials
Dallas, Texas 75230
Principal Investigator: Julio Rosenstock
Phone: 972-566-7799
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Fall River, Massachusetts 02721
Principal Investigator: Ehab Sorial
Phone: 508-672-7450
?
mi
from
Fall River, MA
Click here to add this to my saved trials
Fargo, North Dakota 58103
Principal Investigator: Michael Lillestol
Phone: 701-232-7705
?
mi
from
Fargo, ND
Click here to add this to my saved trials
Farmington, Utah 84025
Principal Investigator: Daniel J Humiston
Phone: 801-292-1315
?
mi
from
Farmington, UT
Click here to add this to my saved trials
Federal Way, Washington 98003
Principal Investigator: Larry Stonesifer
Phone: 253-927-7256
?
mi
from
Federal Way, WA
Click here to add this to my saved trials
Flint, Michigan 48504
Principal Investigator: Ahmed Arif
Phone: 810-237-1125
?
mi
from
Flint, MI
Click here to add this to my saved trials
Greenbrae, California 94904
Principal Investigator: Linda M Gaudiani
Phone: 415-461-9113
?
mi
from
Greenbrae, CA
Click here to add this to my saved trials
Greensboro, North Carolina 27408
Principal Investigator: Alexander V. Murray
Phone: 336-574-8020
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Houston, Texas 77070
Principal Investigator: Najmuddin Karimjee
Phone: 281-370-7272
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntington Beach, California 92648
Principal Investigator: Paul Rosenblit
Phone: 714-375-7386
?
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
Huntington Park, California 90255
Principal Investigator: Stanley Hsia
Phone: 323-588-1968
?
mi
from
Huntington Park, CA
Click here to add this to my saved trials
Idaho Falls, Idaho 83404
Principal Investigator: Carl D Vance
Phone: 208-542-6005
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
Kalispell, Montana 59901
Principal Investigator: Jose de Souza
Phone: 406-751-5309
?
mi
from
Kalispell, MT
Click here to add this to my saved trials
Knoxville, Tennessee 37923
Principal Investigator: Evelyne Davidson
Phone: 865-200-8364
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
La Jolla, California
Principal Investigator: Athena Philis-Tsimikas
Phone: 858-678-7077
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Lancaster, California 93534
Principal Investigator: Kanagaratnam Sivalingam
Phone: 646-642-6189
?
mi
from
Lancaster, CA
Click here to add this to my saved trials
1970 North Broad Street
Lansdale, Pennsylvania 19446
Principal Investigator: Michael Parke
Phone: 215-368-1900
?
mi
from
Lansdale, PA
Click here to add this to my saved trials
Las Vegas, Nevada 89102
Principal Investigator: Betsy M Palal
Phone: 702-736-5161
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Louisville, Kentucky 40202
Principal Investigator: Sathya S Krishnasamy
Phone: 502-287-5128
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Margate, Florida 33063
Principal Investigator: Juan P Loy
Phone: 954-582-7007
?
mi
from
Margate, FL
Click here to add this to my saved trials
Mauldin, South Carolina 29662
Principal Investigator: Anne Tuggle
Phone: 864-680-0762
?
mi
from
Mauldin, SC
Click here to add this to my saved trials
Meridian, Idaho 83646
Principal Investigator: David Butuk
Phone: 208-288-0123
?
mi
from
Meridian, ID
Click here to add this to my saved trials
Miami, Florida 33175
Principal Investigator: Lazaro Nunez
Phone: 305-226-3933
?
mi
from
Miami, FL
Click here to add this to my saved trials
Missoula, Montana
Principal Investigator: Clancy L Cone
Phone: 406-549-1124
?
mi
from
Missoula, MT
Click here to add this to my saved trials
6001 Airport Boulevard
Mobile, Alabama 36608
Principal Investigator: Judson K Menefee
Phone: 251-410-3081
?
mi
from
Mobile, AL
Click here to add this to my saved trials
Montclair, California 91763
Principal Investigator: Rizwana H. Mohseni
Phone: 909-203-4707
?
mi
from
Montclair, CA
Click here to add this to my saved trials
Monterey, California 93940
Principal Investigator: James W Chu
Phone: 831-375-6334
?
mi
from
Monterey, CA
Click here to add this to my saved trials
Nampa, Idaho 83686
Principal Investigator: Stanley Stringam
Phone: 208-463-3081
?
mi
from
Nampa, ID
Click here to add this to my saved trials
Nashua, New Hampshire 03063
Principal Investigator: Robert J Silver
Phone: 603-577-5760
?
mi
from
Nashua, NH
Click here to add this to my saved trials
875 Poplar Church Road
Newport, Pennsylvania 17074
Principal Investigator: Albert B Knouse
Phone: 717-513-9171
?
mi
from
Newport, PA
Click here to add this to my saved trials
1010 24th Avenue Northwest
Norman, Oklahoma 73069
Principal Investigator: Lisa Connery
Phone: 405-701-8999
?
mi
from
Norman, OK
Click here to add this to my saved trials
Northridge, California 91325
Principal Investigator: Christopher Chow
Phone: 818-280-4220
?
mi
from
Northridge, CA
Click here to add this to my saved trials
Olympia, Washington 98502
Principal Investigator: Eric J. Klein
Phone: 360-786-0692
?
mi
from
Olympia, WA
Click here to add this to my saved trials
Orlando, Florida 32806
Principal Investigator: Michael E Dever
Phone: 407-425-5100
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Palm Springs, California 92262
Principal Investigator: Michael R Jardula
Phone: 760-320-9505
?
mi
from
Palm Springs, CA
Click here to add this to my saved trials
Pasadena, California 91105
Principal Investigator: John K De Beixedon
Phone: 626-395-7732
?
mi
from
Pasadena, CA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15243
Principal Investigator: Raman Purighalla
Phone: 412-942-0023
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Pomona, California 91766
Principal Investigator: Airani Sathananthan
Phone: 909-706-3818
?
mi
from
Pomona, CA
Click here to add this to my saved trials
Port Orange, Florida 32127
Principal Investigator: Alexander J White
Phone: 386-304-7070
?
mi
from
Port Orange, FL
Click here to add this to my saved trials
San Antonio, Texas 78249
Principal Investigator: Ramon Reyes
Phone: 210-695-1900
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Carlos, California 94070
Principal Investigator: Leila Chaychi
Phone: 650-591-9933
?
mi
from
San Carlos, CA
Click here to add this to my saved trials
Shavano Park, Texas 78231
Principal Investigator: Michelle Welch
Phone: 210-545-4900
?
mi
from
Shavano Park, TX
Click here to add this to my saved trials
Skokie, Illinois 60076
Principal Investigator: Liana Billings
Phone: 847-570-2956
?
mi
from
Skokie, IL
Click here to add this to my saved trials
Suwanee, Georgia 30024
Principal Investigator: Lee Edward Herman
Phone: 6782053456
?
mi
from
Suwanee, GA
Click here to add this to my saved trials
Sylmar, California 91342
Principal Investigator: Vahid Mahabadi
Phone: 747-210-3205
?
mi
from
Sylmar, CA
Click here to add this to my saved trials
Tomball, Texas 77375
Principal Investigator: Earl E Martin
Phone: 832-843-0200
?
mi
from
Tomball, TX
Click here to add this to my saved trials
Troy, Michigan 48098
Principal Investigator: Neil Fraser
Phone: 248-312-0025
?
mi
from
Troy, MI
Click here to add this to my saved trials
Tustin, California 92780
Principal Investigator: Joanna T Van
Phone: 714-760-9317
?
mi
from
Tustin, CA
Click here to add this to my saved trials
Vallejo, California 94592
Principal Investigator: Jay Shubrook
Phone: 707-638-5969
?
mi
from
Vallejo, CA
Click here to add this to my saved trials
Ventura, California 93003
Principal Investigator: Ronald H Chochinov
Phone: 805-658-8460
?
mi
from
Ventura, CA
Click here to add this to my saved trials
Walla Walla, Washington 99362
Principal Investigator: Eric M. Ball
Phone: 509-525-3720
?
mi
from
Walla Walla, WA
Click here to add this to my saved trials
Walnut creek, California 94598
Principal Investigator: Helen L. Stacey
Phone: 925-930-7267
?
mi
from
Walnut creek, CA
Click here to add this to my saved trials
1031 Office Park Road
West Des Moines, Iowa 50265
Principal Investigator: Anuj Bhargava
Phone: 515-329-6800
?
mi
from
West Des Moines, IA
Click here to add this to my saved trials