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

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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
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Cleveland, Ohio 44122
Principal Investigator: Toby J Briskin
Phone: 216-682-0320
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Iowa City, Iowa 52242
Principal Investigator: JENNIFER G. ROBINSON
Phone: 319-384-5030
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2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
Principal Investigator: Juan P Frias
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2128 W Flagler St # 201
Miami, Florida 33144
Principal Investigator: Mark E. Kutner
Phone: 305-631-6704
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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...
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500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
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Anaheim, California 92805
Principal Investigator: Patrick Walsh
Phone: 714-999-6688
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Atlanta, Georgia 30312
Principal Investigator: Courtney Shelton
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Beaver, Pennsylvania 15009
Principal Investigator: Michael J Oliver
Phone: 724-774-7743
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Burke, Virginia 22015
Principal Investigator: Nashwa Gabra
Phone: 703-455-9711
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Caba, Buenos Aires
Principal Investigator: Elizabeth Gelersztein
Phone: 541148238701
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Camp Hill, Pennsylvania 17011
Principal Investigator: Venkatesh Nadar
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Chesterfield, Missouri 63141
Principal Investigator: Timothy W. Jennings
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Chicago, Illinois 60611
Principal Investigator: Grazia Aleppo
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Clarksville, Tennessee 37040
Principal Investigator: Jacqueline Milam
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Columbus, Ohio 43210
Principal Investigator: Kathleen Dungan
Phone: 614-688-6885
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Columbus, Ohio 43213
Principal Investigator: Samir Arora
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Cooper City, Florida 33024
Principal Investigator: Lorena Lewy-Alterbaum
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Corvallis, Oregon 97330
Principal Investigator: Michael C Chen
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Cutler Bay, Florida 33189
Principal Investigator: Miguel Mujica-Baella
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Dallas, Texas 75230
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Fall River, Massachusetts 02721
Principal Investigator: Ehab Sorial
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Fargo, North Dakota 58103
Principal Investigator: Michael Lillestol
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Flint, Michigan 48504
Principal Investigator: Ahmed Arif
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Principal Investigator: Linda M Gaudiani
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Principal Investigator: Paul Rosenblit
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Principal Investigator: Stanley Hsia
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Principal Investigator: Carl D Vance
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Principal Investigator: Jose de Souza
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Knoxville, Tennessee 37923
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1970 North Broad Street
Lansdale, Pennsylvania 19446
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Louisville, Kentucky 40202
Principal Investigator: Sathya S Krishnasamy
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Mauldin, South Carolina 29662
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875 Poplar Church Road
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1031 Office Park Road
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