A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes



Status:Active, not recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:1/17/2019
Start Date:April 5, 2018
End Date:October 7, 2019

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A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Investigational Dulaglutide Doses When Added to Metformin in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the efficacy and safety of investigational doses of
once weekly dulaglutide when added to metformin in participants with type 2 diabetes with
inadequate blood sugar control.


Inclusion Criteria:

- Have type 2 diabetes mellitus (T2DM) for at least 6 months

- Have been treated with stable metformin dose for at least 3 months

- Have HbA1c ≥7.5% and ≤11.0% at study entry

- Have body mass index (BMI) ≥25 kilograms per meter squared (kg/m^2)

Exclusion Criteria:

- Have type 1 diabetes mellitus

- Have used any glucagon-like peptide-1 receptor agonist (GLP-1 RA) or insulin, not
including prior short term insulin use (≤14 days)

- Have been taking any other medicine for diabetes (other than metformin) during the
last 3 months

- Have used in the last 3 months (or plan to use) prescription weight loss medications

- Have disorders associated with slowed emptying of the stomach contents, or have had
any stomach surgeries for the purpose of weight loss

- Current participation in or intent to begin during the study an organized diet and/or
exercise weight reduction program (other than the lifestyle and dietary measures for
diabetes)

- Have acute or chronic hepatitis, signs and symptoms of any other liver disease other
than nonalcoholic fatty liver disease (NAFLD), or alanine transaminase (ALT) level
>2.5 times the upper limit of the reference range, as determined by the central
laboratory at study entry; participants with NAFLD are eligible for participation in
this trial

- Had chronic or acute pancreatitis any time prior to study entry

- Have had a heart attack or stroke in the past 2 months, or have heart failure that
significantly limits their physical activity

- Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73m^2 (or lower
than the country-specific threshold for discontinuing metformin therapy per local
label), calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as
determined by the central laboratory at study entry and confirmed at lead-in

- Have a personal or family history of medullary thyroid carcinoma or personal history
of multiple endocrine neoplasia syndrome type 2

- Have proliferative retinopathy or maculopathy requiring acute treatment according to
the opinion of the investigator
We found this trial at
73
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Pittsburgh, Pennsylvania 15243
Principal Investigator: Bryce A Palchick
Phone: 412-650-6155
2119
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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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500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
Principal Investigator: Joseph Soufer
Phone: 203-419-4404
2478
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Principal Investigator: Amina Z Haggag
Phone: 714-774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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Beaver, Pennsylvania 15009
Principal Investigator: Michael J Oliver
Phone: 724-774-7743
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Billings, Montana 59102
Principal Investigator: Michael Hagan
Phone: 406-652-6630
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Blackfoot, Idaho 83221
Principal Investigator: Gary Soucie
Phone: 208-643-0006
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Bountiful, Utah 84010
Principal Investigator: Ralph Wade
Phone: 801-298-9155
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Caba, Buenos Aires
Principal Investigator: Pablo Costanzo
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Chandler, Arizona 85224
Principal Investigator: Randall J Severance
Phone: 480-775-1115
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Charlotte, North Carolina 28204
Principal Investigator: Karlton S Pettis
Phone: 704-372-9393
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2205 McCallie Avenue
Chattanooga, Tennessee 37404
Principal Investigator: Eugene Ryan
Phone: 423-643-2253
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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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Cooper City, Florida 33024
Principal Investigator: Lorena Lewy-Alterbaum
Phone: 754-263-2000
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801 Monterey Street
Coral Gables, Florida 33134
Principal Investigator: Jeffrey B Rosen
Phone: 305-445-5637
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Corvallis, Oregon 97330
Principal Investigator: Michael C Chen
Phone: 541-754-1398
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Dallas, Texas 75230
Principal Investigator: Julio Rosenstock
Phone: 972-566-7799
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985C South Kenmore Drive
Evansville, Indiana 47714
Principal Investigator: Mohammed A Allaw
Phone: 812-477-2760
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Fall River, Massachusetts 02721
Principal Investigator: Ehab Sorial
Phone: 508-672-7450
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1201 Flushing Road
Flint, Michigan 48504
Principal Investigator: Ahmed Arif
Phone: 810-237-1125
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Fresno, California 93720
Principal Investigator: Paul Norwood
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Green Bay, Wisconsin 54303
Principal Investigator: Thomas Knutson
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Honolulu, Hawaii 96814
Principal Investigator: David Fitz-Patrick
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Honolulu, Hawaii 96813
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Huntington Park, California 90255
Principal Investigator: Stanley Hsia
Phone: 323-588-1968
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Hyattsville, Maryland 20782
Principal Investigator: Marc Shepard
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Indianapolis, Indiana 46260
Principal Investigator: Phillip D. Toth
Phone: 317-705-7050
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Kalispell, Montana 59901
Principal Investigator: Jose de Souza
Phone: 406-751-5309
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1970 North Broad Street
Lansdale, Pennsylvania 19446
Principal Investigator: Michael Parke
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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Manassas, Virginia 20110
Principal Investigator: Nabil Andrawis
Phone: 703-330-1112
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Marietta, Georgia 30067
Principal Investigator: Cedrice N Davis
Phone: 770-450-9308
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Mesa, Arizona 85206
Principal Investigator: Tami Bruce
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Mesquite, Texas 75149
Principal Investigator: Sumana Gangi
Phone: 214-909-8903
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Miami, Florida 33175
Principal Investigator: Francisco G Miranda
Phone: 305-226-3933
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180 Wingo Way
Moncks Corner, South Carolina 29461
Principal Investigator: Jeremy J. Ackermann
Phone: 843-849-1880
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Montclair, California 91763
Principal Investigator: Rizwana H. Mohseni
Phone: 909-203-4707
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Morehead City, North Carolina 28557
Principal Investigator: Kathryn Jean Lucas
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Nampa, Idaho 83686
Principal Investigator: Stanley Stringam
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New York, New York 10016
Principal Investigator: Susan Zweig
Phone: 212-480-3333
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1010 24th Avenue Northwest
Norman, Oklahoma 73069
Principal Investigator: Lisa Connery
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Northridge, California 91325
Principal Investigator: Christopher Chow
Phone: 818-280-4220
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Oakland, California 94612
Principal Investigator: Anand Y Mehta
Phone: 510-444-2877
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Ogden, Utah 84405
Principal Investigator: Jack D Wahlen
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Oklahoma City, Oklahoma 73103
Principal Investigator: Louise M Thurman
Phone: 405-235-8188
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Olympia, Washington 98502
Principal Investigator: Eric J. Klein
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Oviedo, Florida 32765
Principal Investigator: Bradley M. Block
Phone: 407-977-2705
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2010 Wilshire Boulevard
Panorama City, California 91402
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Peachtree Corners, Georgia 30071
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Roseville, California 95661
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3862 Mexico Road
Saint Peters, Missouri 63303
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San Diego, California 92123
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Shavano Park, Texas 78231
Principal Investigator: Michelle Welch
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Spring Valley, California 91978
Principal Investigator: Hanid Audish
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Springfield, Illinois 62701
Principal Investigator: Frank L Mikell
Phone: 217-787-8870
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Tomball, Texas 77375
Principal Investigator: Earl E Martin
Phone: 832-843-0200
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Trenton, New Jersey 08611
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Troy, Michigan 48098
Principal Investigator: Neil Fraser
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Tustin, California 92780
Principal Investigator: Joanna T Van
Phone: 714-760-9317
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Walla Walla, Washington 99362
Principal Investigator: Eric M. Ball
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Walnut creek, California 94598
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215 Toll Gate Road
Warwick, Rhode Island 02886
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Waxahachie, Texas 75165
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Wenatchee, Washington 98801
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1031 Office Park Road
West Des Moines, Iowa 50265
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Westfield, New York 14787
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