A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
NCT ID: NCT03736785
Last Updated: 2021-03-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
399 participants
INTERVENTIONAL
2018-11-15
2020-02-18
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
NONE
Study Groups
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LY3209590 Algorithm 1
Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of \<140 milligram per deciliter (mg/dL).
LY3209590
Administered SC
LY3209590 Algorithm 2
Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of \<120 mg/dL.
LY3209590
Administered SC
Insulin Degludec
Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C \<7%.
Insulin Degludec
Administered SC
Interventions
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LY3209590
Administered SC
Insulin Degludec
Administered SC
Eligibility Criteria
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Inclusion Criteria
* dipeptidyl peptidase-4 (DPP-4) inhibitors
* sodium-glucose cotransporter (SGLT-2) inhibitors
* biguanides
* alpha-glucosidase inhibitors
* sulfonlyureas
* HbA1c value of 6.5% to 10%, inclusive
* Body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m2), inclusive
Exclusion Criteria
* Any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
* Any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
* Acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
* Estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73 m2
* Active or untreated malignancy
* Chronic (\>14 days) systemic glucocorticoid therapy
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 - 5hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Central Research Associates, Inc.
Birmingham, Alabama, United States
Arkansas Clinical Research
Little Rock, Arkansas, United States
John Muir Physician Network Clinical Research Center
Concord, California, United States
AMCR Institute INC
Escondido, California, United States
Valley Endocrine, Fresno
Fresno, California, United States
Marin Endocrine Associates
Greenbrae, California, United States
National Research Institute
Huntington Park, California, United States
First Valley Medical Group
Lancaster, California, United States
National Research Institute
Los Angeles, California, United States
University Clinical Investigators, Inc.
Tustin, California, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
ALL Medical Research, LLC
Cooper City, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Metabolic Research Institute Inc.
West Palm Beach, Florida, United States
East West Medical Institute
Honolulu, Hawaii, United States
Elite Clinical Trials LLLP
Blackfoot, Idaho, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States
Iderc, P.L.C.
West Des Moines, Iowa, United States
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, United States
Endocrine and Metabolic Consultants
Rockville, Maryland, United States
NECCR PrimaCare Research, LLC
Fall River, Massachusetts, United States
Palm Research Center
Las Vegas, Nevada, United States
Palm Research Center
Las Vegas, Nevada, United States
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, United States
Metrolina Internal Medicine, P.A.
Charlotte, North Carolina, United States
Intend Research
Norman, Oklahoma, United States
The Corvallis Clinic P.C.
Corvallis, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians - Jacob Murphy Lane
Uniontown, Pennsylvania, United States
Internal Medicine Associates of Anderson
Anderson, South Carolina, United States
The Research Center of the Upstate
Mauldin, South Carolina, United States
Texas Diabetes and Endocrinology
Austin, Texas, United States
Dallas Diabetes Endocrine Center
Dallas, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Rainier Clinical Research Center
Renton, Washington, United States
Confluence Health Clinical Research Department
Wenatchee, Washington, United States
Hospital Universitario UANL
Monterrey, Nuevo León, Mexico
Investigacion en Salud y Metabolismo S.C
Chihuahua City, , Mexico
Advanced Clinical Research, LLC
Bayamón, PR, Puerto Rico
Manati Center for Clinical Research Inc
Manatí, PR, Puerto Rico
GCM Medical Group PSC
San Juan, PR, Puerto Rico
Martha Gomez Cuellar M.D.
San Juan, PR, Puerto Rico
Centro de Endocrinologia del Este
Yabucoa, , Puerto Rico
Countries
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References
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Frias J, Chien J, Zhang Q, Chigutsa E, Landschulz W, Syring K, Wullenweber P, Haupt A, Kazda C. Safety and efficacy of once-weekly basal insulin Fc in people with type 2 diabetes previously treated with basal insulin: a multicentre, open-label, randomised, phase 2 study. Lancet Diabetes Endocrinol. 2023 Mar;11(3):158-168. doi: 10.1016/S2213-8587(22)00388-6. Epub 2023 Feb 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
Other Identifiers
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I8H-MC-BDCM
Identifier Type: OTHER
Identifier Source: secondary_id
17059
Identifier Type: -
Identifier Source: org_study_id
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