A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy
NCT ID: NCT02973100
Last Updated: 2019-09-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
318 participants
INTERVENTIONAL
2016-12-31
2017-08-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dulaglutide 4.5mg
4.5mg of Dulaglutide administered subcutaneously (SC)
Dulaglutide
Administered SC
Dulaglutide 3.0mg
3.0mg of Dulaglutide administered SC
Dulaglutide
Administered SC
Dulaglutide 1.5mg
1.5mg of Dulaglutide administered SC
Dulaglutide
Administered SC
Placebo
Placebo administered SC
Placebo
Administered SC
Interventions
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Dulaglutide
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Parexel Early Phase Unit at Glendale
Glendale, California, United States
Marin Endocrine Associates
Greenbrae, California, United States
National Research Institute
Huntington Park, California, United States
National Research Institute
Los Angeles, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Encompass Clinical Research
Spring Valley Lake, California, United States
University Clinical Investigators, Inc.
Tustin, California, United States
Infosphere
Van Nuys, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Axes Medical Research, LLC
Cooper City, Florida, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
East Coast Institute For Research
Jacksonville, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Suncoast Research Group, LLC
Miami Lakes, Florida, United States
Palm Harbor Medical Associates
Palm Harbor, Florida, United States
In-Quest Medical Research, LLC - Norcross
Norcross, Georgia, United States
East West Medical Institute
Honolulu, Hawaii, United States
Elite Cilnical Trials LLLP
Blackfoot, Idaho, United States
Solaris Clinical Research
Meridian, Idaho, United States
HSHS Medical Group Diabetes Research
Springfield, Illinois, United States
American Health Network
Indianapolis, Indiana, United States
Iderc, P.L.C.
Des Moines, Iowa, United States
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, United States
ActivMed Practices & Research, Inc
Methuen, Massachusetts, United States
StudyMetrix Research, LLC
City of Saint Peters, Missouri, United States
Manhattan Medical Research
New York Mills, New York, United States
High Point Clinical Trials Center
High Point, North Carolina, United States
Aventiv Research
Columbus, Ohio, United States
The Corvallis Clinic P.C.
Corvallis, Oregon, United States
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, United States
New Phase Research & Development
Knoxville, Tennessee, United States
Dallas Diabetes Endocrine Center
Dallas, Texas, United States
Consano Clinical Research
San Antonio, Texas, United States
Clinpoint Trial, LLC
Waxahachie, Texas, United States
Chrysalis Clinical Research
St. George, Utah, United States
Rainier Clinical Research Center
Renton, Washington, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Brandýs nad Labem-Stará Boleslav, , Czechia
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Krnov, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Praha 4 - Krc, , Czechia
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Chihuahua City, , Mexico
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Cuernavaca, , Mexico
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Guadalajara, , Mexico
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Monterrey, , Mexico
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Tampico, , Mexico
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Bialystok, , Poland
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Bialystok, , Poland
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Gdansk, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Ruda Śląska, , Poland
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Szczecin, , Poland
Marginal Doctor's Center
Manatí, , Puerto Rico
American Telemedicine Center
San Juan, , Puerto Rico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Alba Iulia, , Romania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Baia Mare, , Romania
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Iași, , Romania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Oradea, , Romania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Satu Mare, , Romania
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy
Other Identifiers
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H9X-MC-GBGJ
Identifier Type: OTHER
Identifier Source: secondary_id
2016-002494-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16568
Identifier Type: -
Identifier Source: org_study_id
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