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

Description

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.

Study Start Date

April, 05 2018

Estimated Completion Date

October 2019

Interventions

  • Drug: Dulaglutide

Study ID

Eli Lilly and Company -- 16877

Status

Recruiting

Trial ID

NCT03495102

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

1800

Sponsor

Eli Lilly and Company

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

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (71)

Study Location Distance Name Phone Email
Chase Medical Research LLC - Waterbury, Connecticut 25.2 miles None None None
Manhattan Medical Research - New York, New York 50.2 miles None None None
Sudir Bansal MD Inc - Warwick, Rhode Island 99.7 miles None None None
Premier Research - Trenton, New Jersey 105.4 miles None None None
NECCR PrimaCare Research LLC - Fall River, Massachusetts 113.5 miles None None None
Detweiler Family Medicine - Lansdale, Pennsylvania 126.8 miles None None None
InterMed PA - Portland, Maine 228.1 miles None None None
MedStar Health Research Institute - Hyattsville, Maryland 251.1 miles None None None
Manassas Clinical Research Center - Manassas, Virginia 282.0 miles None None None
Great Lakes Medical Research - Westfield, New York 335.2 miles None None None
Clinical Research Partners LLC - Richmond, Virginia 346.0 miles None None None
Preferred Primary Care Physicians - Pittsburgh, Pennsylvania 357.9 miles None None None
Heritage Valley Medical Group Inc - Beaver, Pennsylvania 373.2 miles None None None
Diabetes Endocrinology Consultants PC - Morehead City, North Carolina 488.8 miles None None None
Aventiv Research - Columbus, Ohio 513.1 miles None None None
Troy Internal Medicine PC - Troy, Michigan 520.3 miles None None None
AA Medical Research Center - Flint, Michigan 553.2 miles None None None
Metrolina Internal Medicine PA - Charlotte, North Carolina 586.2 miles None None None
PMG Research of Charleston LLC - Moncks Corner, South Carolina 672.0 miles None None None
Midwest Institute for Clinical Research - Indianapolis, Indiana 686.2 miles None None None
Chattanooga Research and Medicine CHARM - Chattanooga, Tennessee 781.8 miles None None None
InQuest Medical Research LLC Peachtree Corners - Peachtree City, Georgia 783.6 miles None None None
Prevea Clinic Inc - Green Bay, Wisconsin 784.7 miles None None None
SynexusClinical Research Advantage - Evansville, Indiana 793.5 miles None None None
Urban Family Practice Associates PC - Marietta, Georgia 795.1 miles None None None
Prairie Education and Research Cooperative - Springfield, Illinois 868.3 miles None None None
Clinical Research Professionals - Saint Louis, Missouri 929.1 miles None None None
StudyMetrix Research LLC - Saint Peters, Missouri 931.7 miles None None None
Oviedo Medical Research - Oviedo, Florida 979.9 miles None None None
Iderc PLC - West Des Moines, Iowa 1,045.1 miles None None None
ALL Medical Research LLC - Cooper City, Florida 1,126.8 miles None None None
Arkansas Clinical Research - Little Rock, Arkansas 1,131.5 miles None None None
Suncoast Research Group LLC - Miami, Florida 1,143.0 miles None None None
Clinical Research of South Florida - Coral Gables, Florida 1,144.4 miles None None None
New Horizon Research Center - Miami, Florida 1,148.7 miles None None None
IPS Research Company - Oklahoma City, Oklahoma 1,371.6 miles None None None
Intend Research - Norman, Oklahoma 1,375.4 miles None None None
Southern Endocrinology and Associates PA - Mesquite, Texas 1,413.0 miles None None None
Dallas Diabetes Endocrine Center - Dallas, Texas 1,417.3 miles None None None
ClinPoint Trials LLC - Waxahachie, Texas 1,436.0 miles None None None
Martin Diagnostic Clinic - Tomball, Texas 1,470.0 miles None None None
Consano Clinical Research - Shavano Park, Texas 1,631.2 miles None None None
Montana Health Research - Billings, Montana 1,788.1 miles None None None
Elite Clinical Trials LLLP - Blackfoot, Idaho 1,994.2 miles None None None
Advanced Research Institute - Ogden, Utah 2,001.1 miles None None None
Progressive Clinical Research - Bountiful, Utah 2,002.0 miles None None None
Glacier View Research Institute - Kalispell, Montana 2,051.7 miles None None None
SynexusCentral Arizona Medical Associates PC - Mesa, Arizona 2,169.1 miles None None None
Synexus Chandler - Chandler, Arizona 2,179.2 miles None None None
Central Phoenix Med Clinic LLC - Phoenix, Arizona 2,181.4 miles None None None
Saltzer Medical Group PA - Nampa, Idaho 2,197.7 miles None None None
Columbia Medical Associates dba Northside Endocrinology - Spokane, Washington 2,199.3 miles None None None
Walla Walla Clinic - Walla Walla, Washington 2,253.8 miles None None None
Confluence Health Clinical Research Department - Wenatchee, Washington 2,335.6 miles None None None
Catalina Research Institute LLC - Montclair, California 2,460.1 miles None None None
Encompass Clinical Research - Spring Valley, California 2,461.9 miles None None None
Capital Clincial Research Center - Olympia, Washington 2,462.6 miles None None None
Summit Research Network Inc - Portland, Oregon 2,468.8 miles None None None
Artemis Institute for Clinical Research - San Diego, California 2,472.6 miles None None None
University Clinical Investigators Inc - Tustin, California 2,476.5 miles None None None
Anaheim Clinical Trials LLC - Anaheim, California 2,480.1 miles None None None
National Research Institute - Huntington Park, California 2,489.6 miles None None None
Valley Research - Fresno, California 2,491.0 miles None None None
Care Access Research - Santa Clara, California 2,494.0 miles None None None
Valley Clinical Trials Inc - Northridge, California 2,498.1 miles None None None
The Corvallis Clinic PC - Corvallis, Oregon 2,508.9 miles None None None
Sierra Clinical Research - Roseville, California 2,520.1 miles None None None
Diablo Clinical Research - Walnut Creek, California 2,580.4 miles None None None
Pacific Research Partners LLC - Oakland, California 2,596.5 miles None None None
East West Medical Institute - Honolulu, Hawaii 5,002.8 miles None None None
The Queens Medical Center - 'Ewa Beach, Hawaii 5,010.5 miles None None None

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