A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes



Status:Not yet recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:April 1, 2019
End Date:November 19, 2020
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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A Randomized, Phase 3, Open-Label Trial Comparing the Effect of LY3298176 Versus Titrated Insulin Degludec on Glycemic Control in Patients With Type 2 Diabetes

The purpose of this study is to compare the effect of the study drug tirzepatide to insulin
degludec on blood sugar levels in participants with type 2 diabetes. The study will last
about 59 weeks and may include up to 22 visits.


Inclusion Criteria:

- Participants must:

- 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 or metformin plus an
SGLT-2 inhibitor for at least 3 months before screening

- Be of stable weight (± 5%) for at least 3 months before screening

- 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 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 mL/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, or metformin
plus an SGLT-2 inhibitor 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
34
sites
Las Vegas, Nevada 89102
Principal Investigator: Betsy M Palal
Phone: 702-736-5163
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11701 San Jose Blvd # 32
Jacksonville, Florida 32223
Principal Investigator: Mae Sheikh-Ali
Phone: 904-854-1354
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Jacksonville, FL
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2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
Principal Investigator: Juan P Frias
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Los Angeles, CA
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500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
Principal Investigator: Joseph Soufer
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Beaver, Pennsylvania 15009
Principal Investigator: Michael J Oliver
Phone: 724-774-7743
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Blackfoot, Idaho 83221
Principal Investigator: Gary Soucie
Phone: 208-643-0006
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Boise, Idaho 83701
Principal Investigator: Sherwin D'Souza
Phone: 208-287-9429
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Caba, Buenos Aires
Principal Investigator: Elizabeth Gelersztein
Phone: 541148238701
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Chesterfield, Missouri 63141
Principal Investigator: Timothy W. Jennings
Phone: 636-220-1200
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Columbus, Ohio 43213
Principal Investigator: Samir Arora
Phone: 614-501-6164
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Corpus Christi, Texas 78414
Principal Investigator: Osvaldo A Brusco
Phone: 361-885-0448
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Corvallis, Oregon 97330
Principal Investigator: Michael C Chen
Phone: 541-754-1398
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Fresno, California 93720
Principal Investigator: Paul C Norwood
Phone: 559-261-0992
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Hialeah, Florida 33012
Principal Investigator: Jose Cardona
Phone: 305-825-6588
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Huntington Park, California 90255
Principal Investigator: Stanley Hsia
Phone: 323-588-1968
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Idaho Falls, Idaho 83404
Principal Investigator: Carl D Vance
Phone: 208-542-6005
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Jacksonville, Florida 32204
Principal Investigator: James S Magee
Phone: 904-384-2240
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1970 North Broad Street
Lansdale, Pennsylvania 19446
Principal Investigator: Evan Kessler
Phone: 215-368-1900
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Little Rock, Arkansas 72205
Principal Investigator: Kevin D Roberts
Phone: 501-907-9170
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Macon, Georgia 31210
Principal Investigator: Thomas C Jones
Phone: 478-746-8626
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Metairie, Louisiana 70006
Principal Investigator: Harold Miller
Phone: 985-273-5158
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Minneapolis, Minnesota 55416
Principal Investigator: Thomas Martens
Phone: 952-993-1517
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Montclair, California 91763
Principal Investigator: Rizwana H. Mohseni
Phone: 909-590-8409
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New Orleans, Louisiana 70121
Principal Investigator: Lawrence Blonde
Phone: 504-894-2863
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7114 Congress Street
New Port Richey, Florida 34655
Principal Investigator: Tatiana Hernandez Guerrero
Phone: 727-853-1800
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Northridge, California 91325
Principal Investigator: Christopher Chow
Phone: 818-280-4220
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2010 Wilshire Boulevard
Panorama City, California 91402
Principal Investigator: Parvin D Syal
Phone: 818-532-6880
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3200 Tower Oaks Boulevard
Rockville, Maryland 20852
Principal Investigator: Michael Dempsey
Phone: 301-770-7373
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Shavano Park, Texas 78231
Principal Investigator: Michelle Welch
Phone: 210-545-4900
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Spring Valley, California 91978
Principal Investigator: Hanid Audish
Phone: 619-660-9068
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Springfield, Illinois 62704
Principal Investigator: Frank L Mikell
Phone: 217-787-8870
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Troy, Michigan 48098
Principal Investigator: Neil Fraser
Phone: 248-312-0025
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Tustin, California 92780
Principal Investigator: Joanna T Van
Phone: 714-734-7944
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Union City, Georgia 30291
Principal Investigator: Dwight Blake
Phone: 888-659-4363
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