A Study of LY3209590 in Participants With Type 1 Diabetes
NCT ID: NCT04450407
Last Updated: 2022-10-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
266 participants
INTERVENTIONAL
2020-07-06
2021-10-01
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 (Paper)
Algorithm 1 is a paper-based algorithm where dose adjustments were manually determined by the investigator based on fasting glucose and hypoglycemia data. LY3209590 was provided in a 20 milligram (mg) vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by subcutaneous (SC) injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 milligrams per deciliter (mg/dL).
LY3209590
Administered SC
LY3209590 Algorithm 2 (Digital)
Algorithm 2 is a computer-based algorithm to determine dose adjustments. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 mg/dL.
As per protocol amendment (d) approved on 28-Oct-2020, this arm was terminated during the early enrollment phase due to technical issues with data entry.
LY3209590
Administered SC
Insulin Degludec
Insulin degludec was provided as 100 units/milliliter (U/mL) in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose same as basal insulin dose prior randomization, during the 26-week treatment period, to achieve target fasting blood glucose of \<=100 mg/dL.
Insulin Degludec
Administered SC
Interventions
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LY3209590
Administered SC
Insulin Degludec
Administered SC
Eligibility Criteria
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Inclusion Criteria
* Participants must have been using multiple daily injections without interruption for at least 3 months
* Participants must have HbA1c values of 5.6% to 9.5%, inclusive
* Participants must have a body mass index (BMI) of ≤35 kilograms per meter squared (kg/m²)
Exclusion Criteria
* Have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
* Have any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
* Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
* Have an estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73 m²
* Have active or untreated cancer
* Are receiving 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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John Muir Physician Network Clinical Research Center
Concord, California, United States
Valley Endocrine, Fresno
Fresno, California, United States
Coastal Metabolic Research Centre
Ventura, California, United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
Denver Endocrinology, Diabetes & Thyroid Center
Englewood, Colorado, United States
East Coast Institute for Research at The Jones Center
Jacksonville, Florida, United States
Sun Coast Clinical Research, Inc
New Port Richey, Florida, United States
Bayside Clinical Research, LLC
New Port Richey, Florida, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
East Coast Institute for Research at The Jones Center
Macon, Georgia, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Diabetes and Metabolism Associates, APMC
Metairie, Louisiana, United States
Endocrine and Metabolic Consultants
Rockville, Maryland, United States
Palm Research Center Tenaya
Las Vegas, Nevada, United States
Southern Nh Diabetes and Endocrinology
Nashua, New Hampshire, United States
Suny Health Science Center at Syracuse
Syracuse, New York, United States
Lucas Research, Inc.
Morehead City, North Carolina, United States
PMG Research of Piedmont Healthcare
Statesville, North Carolina, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
Intend Research, LLC
Norman, Oklahoma, United States
Holston Medical Group
Bristol, Tennessee, United States
Univ Diab & Endo Consult
Chattanooga, Tennessee, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, United States
Research Institute of Dallas
Dallas, Texas, United States
Diabetes and Thyroid Center of Fort Worth
Fort Worth, Texas, United States
Endocrine and Psychiatry Center
Houston, Texas, United States
Southern Endocrinology Associates
Mesquite, Texas, United States
Texas Diabetes & Endocrinology, P.A.
Round Rock, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Rainier Clinical Research Center
Renton, Washington, United States
Universitätsklinikum Graz
Graz, Styria, Austria
Klinik Landstraße
Vienna, , Austria
Zentrum für klinische Studien Dr Hanusch Gmbh
Vienna, , Austria
Praxis Dr. Jörg Lüdemann
Falkensee, Brandenburg, Germany
InnoDiab Forschung Gmbh
Essen, North Rhine-Westphalia, Germany
Institut für Diabetesforschung GmbH Münster
Münster, North Rhine-Westphalia, Germany
Practice Dr.med. Denger and Dr.med. Pfitzner
Friedrichsthal, Saarland, Germany
Zentrum für klinische Studien
Saint Ingbert, Saarland, Germany
SMO.MD GmbH
Magdeburg, Saxony-Anhalt, Germany
RED-Institut GmbH
Oldenburg in Holstein, Schleswig-Holstein, Germany
Diabeteszentrum Hamburg West
Hamburg, , Germany
Dr Altagracia Aurora Alcantara Gonzalez
Bayamón, PR, Puerto Rico
Advanced Clinical Research, LLC
Bayamón, PR, Puerto Rico
Martha Gomez Cuellar M.D.
San Juan, PR, Puerto Rico
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, Spain
Hospital Quiron Infanta Luisa
Seville, Andalusia, Spain
Hospital Universitario de La Ribera
Alzira, Valencia, Spain
Complexo Hospitalario Universitario A Coruña, CHUAC
A Coruña, , Spain
Centro Periférico de Especialidades Bola Azul
Almería, , Spain
Clínica nuevas Tecnologías en Diabetes y Endocrinología
Seville, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Countries
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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 1 Diabetes
Other Identifiers
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I8H-MC-BDCP
Identifier Type: OTHER
Identifier Source: secondary_id
2019-003589-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17183
Identifier Type: -
Identifier Source: org_study_id
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