A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:8/26/2018
Start Date:December 2016
End Date:August 14, 2017

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A Phase 2, Double-Blind, Placebo-Controlled, 18-Week Trial of Investigational Dulaglutide Doses Versus Placebo in Patients With Type 2 Diabetes on Metformin Monotherapy

The purpose of this study is to evaluate the efficacy and safety of investigational doses of
dulaglutide in participants with type 2 diabetes on metformin monotherapy.


Inclusion Criteria:

- Have had type 2 diabetes (T2D) for ≥6 months according to the World Health
Organization (WHO) classification

- Have HbA1c of 7.0% to 10.0%, inclusive, as assessed by the central laboratory

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

- Have a body mass index (BMI) ≥25 kilograms per square meter

Exclusion Criteria:

- Have type 1 diabetes (T1D)

- Have used any glucose-lowering medication other than metformin 3 months prior to study
entry or during screening/lead-in period or have used any glucagon-like peptide-1
receptor agonists (GLP-1 RAs) at any time in the past

- Have had any of the following cardiovascular conditions: acute myocardial infarction
(MI), New York Heart Association Class III or Class IV heart failure, or
cerebrovascular accident (stroke)

- Have acute or chronic hepatitis, signs and symptoms of any other liver disease other
than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (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

- Have had chronic or acute pancreatitis any time prior to study entry

- Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 square
meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation

- Have serum calcitonin ≥20 picograms per milliliter, as determined by the central
laboratory at study entry
We found this trial at
39
sites
San Antonio, Texas 78258
Principal Investigator: Michelle Welch
Phone: 210-545-4900
1752
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San Antonio, TX
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11701 San Jose Blvd # 32
Jacksonville, Florida 32223
Principal Investigator: Mae Sheikh-Ali
Phone: 904-384-2240
1025
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Jacksonville, FL
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2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
Principal Investigator: Juan Frias
2589
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Los Angeles, CA
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500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
Principal Investigator: Joseph Soufer
115
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Waterbury, CT
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Beaver, Pennsylvania 15009
Principal Investigator: Michael Oliver
Phone: 724-774-7743
489
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Beaver, PA
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Blackfoot, Idaho 83221
Principal Investigator: Gary Soucie
Phone: 208-643-0006
2070
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Brandýs Nad Labem-Stará Boleslav, 25001
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Brandýs Nad Labem-Stará Boleslav,
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Columbus, Ohio 43213
Principal Investigator: Samir Arora
Phone: 614-501-6164
633
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Cooper City, Florida 33024
Principal Investigator: Lorena Lewy-Alterbaum
Phone: 754-263-2000
1240
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Cooper City, FL
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801 Monterey Street
Coral Gables, Florida 33134
Principal Investigator: Jeffrey Rosen
Phone: 305-445-5637
1259
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Coral Gables, FL
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Corvallis, Oregon 97330
Principal Investigator: Michael Chen
Phone: 541-754-1398
2574
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Dallas, Texas 75230
Principal Investigator: Julio Rosenstock
Phone: 972-566-7799
1542
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Des Moines, Iowa 50314
Principal Investigator: Anuj Bhargava
Phone: 515-643-5122
1154
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Glendale, California 91206
Principal Investigator: Hakop Gevorkyan
Phone: 818-254-1624
2583
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Greenbrae, California 94904
Principal Investigator: Linda Gaudiani
Phone: 415-461-9113
2690
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High Point, North Carolina 27265
Principal Investigator: Margarita Nunez
Phone: 336-841-0700
650
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Honolulu, Hawaii 96814
Principal Investigator: David Fitz-Patrick
Phone: 808-531-6886
5078
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Huntington Park, California 90255
Principal Investigator: Stanley Hsia
Phone: 323-588-1968
2589
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Indianapolis, Indiana 46254
Principal Investigator: Thomas Moretto
Phone: 317-387-3355
807
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Knoxville, Tennessee 37923
Principal Investigator: Evelyne Davidson
Phone: 865-200-8364
815
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Meridian, Idaho 83646
Principal Investigator: David Butuk
Phone: 208-288-0123
2263
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Meridian, ID
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Methuen, Massachusetts 01844
Principal Investigator: Michael McCartney
Phone: 978-655-7155
25
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Miami, Florida 33175
Principal Investigator: Francisco Miranda
Phone: 305-226-3933
1260
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Miami Lakes, Florida 33135
Principal Investigator: Mark Kutner
Phone: 305-631-6704
1251
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Miami Lakes, FL
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Montclair, California 91763
Principal Investigator: Gilbert Martinez
Phone: 909-445-8451
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New York Mills, New York 10016
Principal Investigator: Susan Zweig
Phone: 212-480-3333
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Norcross, Georgia 30071
Principal Investigator: Suresh Shah
Phone: 770-903-0148
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Palm Harbor, Florida 34684
Principal Investigator: Aron Schlau
Phone: 727-785-4540
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Renton, Washington 98057
Principal Investigator: Leslie Klaff
Phone: 425-251-1720
2479
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736 South 900 East
Saint George, Utah 84790
2261
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3862 Mexico Road
Saint Peters, Missouri 63303
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San Diego, California 92123
Principal Investigator: Purvi Mehra
Phone: 858-278-3647
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Spring Valley Lake, California 91978
Principal Investigator: Robert Lipetz
Phone: 619-660-9068
2581
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Springfield, Illinois 62711
Principal Investigator: Frank Mikell
Phone: 217-546-2064
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Topeka, Kansas 66606
Principal Investigator: Alan Wynne
Phone: 785-354-9591
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Tustin, California 92780
Principal Investigator: Jean-Louis Selam
Phone: 714-734-7944
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Van Nuys, California 91405
Principal Investigator: Dan Streja
Phone: 818-222-6868
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Walnut creek, California 94598
Principal Investigator: Mark Christiansen
Phone: 925-930-7267
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Waxahachie, Texas 75165
Principal Investigator: Thomas Ledbetter
Phone: 972-937-1640
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