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
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 | |
|---|---|---|---|---|
| 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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