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
sites
215 Toll Gate Road
Warwick, Rhode Island 02886
Principal Investigator: Sudhir Bansal
Phone: 401-773-7855
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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
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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
Phone: 541149013929
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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
Phone: 559-261-0992
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Green Bay, Wisconsin 54303
Principal Investigator: Thomas Knutson
Phone: 920-272-1050
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Honolulu, Hawaii 96814
Principal Investigator: David Fitz-Patrick
Phone: 808-531-6886
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Honolulu, Hawaii 96813
Principal Investigator: Alan Parsa
Phone: 808-526-0303
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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
Phone: 301-560-2929
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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
Phone: 480-751-2480
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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
Phone: 2522225700
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Nampa, Idaho 83686
Principal Investigator: Stanley Stringam
Phone: 208-463-3081
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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
Phone: 405-701-8999
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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
Phone: 801-409-2040
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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
Phone: 360-786-0692
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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
Principal Investigator: Parvin D Syal
Phone: 818-532-6880
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Peachtree Corners, Georgia 30071
Principal Investigator: Suresh Shah
Phone: 770-903-0148
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Phoenix, Arizona 85020
Principal Investigator: Ernie Riffer
Phone: 602-200-3814
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Pittsburgh, Pennsylvania 15243
Principal Investigator: Bryce A Palchick
Phone: 412-650-6155
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Portland, Maine 04101
Principal Investigator: William Ervin
Phone: 207-774-5816
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Portland, Oregon 97210
Principal Investigator: James H. Bergthold
Phone: 503-279-8252
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Richmond, Virginia
Principal Investigator: Jerome Daniel
Phone: 804-308-8659
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Roseville, California 95661
Principal Investigator: Jakkidi Reddy
Phone: 916-782-6337
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3862 Mexico Road
Saint Peters, Missouri 63303
Principal Investigator: Timothy R Smith
Phone: 636-387-5100
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San Diego, California 92123
Principal Investigator: Purvi Mehra
Phone: 858-278-3647
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Santa Clarita, California 91321
Principal Investigator: Sina Tebi
Phone: 661-286-2360
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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 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
Principal Investigator: Jane L Rohlf
Phone: 609-392-6666
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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: 714-760-9317
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Walla Walla, Washington 99362
Principal Investigator: Eric M. Ball
Phone: 509-525-3720
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Walnut creek, California 94598
Principal Investigator: Helen L. Stacey
Phone: 925-930-7267
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Waxahachie, Texas 75165
Principal Investigator: Thomas Glenn Ledbetter
Phone: 9729613949
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Wenatchee, Washington 98801
Principal Investigator: Steven R Kaster
Phone: 509-665-5800
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1031 Office Park Road
West Des Moines, Iowa 50265
Principal Investigator: Anuj Bhargava
Phone: 515-643-5122
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Westfield, New York 14787
Principal Investigator: Donald Brautigam
Phone: 716-326-4890
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