A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
NCT ID: NCT04450394
Last Updated: 2022-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
278 participants
INTERVENTIONAL
2020-07-01
2021-10-08
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 baseline median fasting glucose and body weight 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 baseline median fasting glucose and body weight 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 of 10 units, 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 a HbA1c value of 7.0% to 9.5%, inclusive
* Participants must have a body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m²), inclusive
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
75 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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Syed Research Consultants Llc
Sheffield, Alabama, United States
National Research Institute - Huntington Park
Huntington Park, California, United States
National Research Institute - Wilshire
Los Angeles, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Encompass Clinical Research
Spring Valley, California, United States
CMR of Greater New Haven
Waterbury, Connecticut, United States
ALL Medical Research, LLC
Cooper City, Florida, United States
Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, United States
Suncoast Research Group
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Rophe Adult and Pediatric Medicine
Union City, Georgia, United States
Elite Clinical Trials
Blackfoot, Idaho, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States
Elite Clinical Trials
Rexburg, Idaho, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, United States
L-MARC Research Center
Louisville, Kentucky, United States
Endocrine and Metabolic Consultants
Rockville, Maryland, United States
Sky Clin Resch - Quinn HC
Ridgeland, Mississippi, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Intend Research, LLC
Norman, Oklahoma, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, United States
Holston Medical Group
Bristol, Tennessee, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, United States
Dallas Diabetes Research Center
Dallas, Texas, United States
Juno Research
Houston, Texas, United States
Juno Research - Gessner
Houston, Texas, United States
Southern Endocrinology Associates
Mesquite, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Rainier Clinical Research Center
Renton, Washington, United States
Centro Médico Viamonte
CABA, Buenos Aires, Argentina
Investigaciones Medicas Imoba Srl
CABA, Buenos Aires, Argentina
Fundacion Sanatorio Guemes
CABA, Buenos Aires, Argentina
Consultorio de Investigación Clínica EMO SRL
Caba, Buenos Aires, Argentina
CEDIC
CABA, Buenos Aires, Argentina
Instituto Médico Catamarca
Rosario, Santa Fe Province, Argentina
CEMEDIC
Buenos Aires, , Argentina
Asociación de Beneficencia Hospital Sirio Libanés
Buenos Aires, , Argentina
Instituto Centenario
Ciudad Autonoma de Buenos Aire, , Argentina
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
Córdoba, , Argentina
Clínica Mayo
San Miguel de Tucumán, , Argentina
Diabetes- und Stoffwechselpraxis Bochum
Bochum, North Rhine-Westphalia, 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
Private Practice - Dr. Christine Kosch
Pirna, Saxony, Germany
SMO.MD GmbH
Magdeburg, Saxony-Anhalt, Germany
RED-Institut GmbH
Oldenburg in Holstein, Schleswig-Holstein, Germany
Diabeteszentrum Hamburg West
Hamburg, , Germany
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
Krakow, Lesser Poland Voivodeship, Poland
Instytut Diabetologii Sp. z o.o
Warsaw, Masovian Voivodeship, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, Poland
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
Ruda Śląska, Silesian Voivodeship, Poland
Centrum Kliniczno-Badawcze
Elblag, , Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, , Poland
Gabinety TERPA
Lublin, , Poland
OMEDICA Medical Center
Poznan, , Poland
Praktyka Lekarska
Poznan, , Poland
Poradnia Chorob Metabolicznych
Wierzchosławice, , Poland
NZOZ Regionalna Poradnia Diabetologiczna
Wroclaw, , Poland
Research and Cardiovascular Corp.
Ponce, PR, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
San Juan, PR, Puerto Rico
Centro Profesional de Endocrinologia del Este
Yabucoa, PR, Puerto Rico
Countries
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References
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Bue-Valleskey JM, Kazda CM, Ma C, Chien J, Zhang Q, Chigutsa E, Landschulz W, Haupt A, Frias JP. Once-Weekly Basal Insulin Fc Demonstrated Similar Glycemic Control to Once-Daily Insulin Degludec in Insulin-Naive Patients With Type 2 Diabetes: A Phase 2 Randomized Control Trial. Diabetes Care. 2023 May 1;46(5):1060-1067. doi: 10.2337/dc22-2396.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
Other Identifiers
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I8H-MC-BDCL
Identifier Type: OTHER
Identifier Source: secondary_id
2019-003339-53
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17056
Identifier Type: -
Identifier Source: org_study_id
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