A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
A Phase 2, Parallel, Comparator-Controlled Trial to Evaluate the Safety and Efficacy of LY3209590 in Insulin-Naïve Patients With Type 2 Diabetes Mellitus
3 other identifiers
interventional
278
5 countries
64
Brief Summary
The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes-mellitus
Started Jul 2020
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2020
CompletedFirst Posted
Study publicly available on registry
June 29, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2021
CompletedResults Posted
Study results publicly available
November 2, 2022
CompletedNovember 2, 2022
October 1, 2022
1.3 years
June 26, 2020
October 6, 2022
October 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of haemoglobin A. It is measured to identify average blood glucose concentration over prolonged periods of time. Least squares (LS) mean change from baseline was analysed by mixed model repeated measures (MMRM) model with treatment, country, Dipeptidyl peptidase IV (DPPIV) (yes/no), Sodium-glucose Cotransporter-2 (SGLT2) (yes/no), baseline body mass index (BMI) \[\<30, \>=30\]), visit, and treatment by visit interaction as fixed effects and the baseline HbA1c as a covariate.
Baseline, Week 26
Secondary Outcomes (3)
Change From Baseline in Fasting Serum Glucose
Baseline, Week 26
Rate of Documented Hypoglycemia
Baseline through Week 26
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590
Week 26
Study Arms (3)
LY3209590 Algorithm 1 (Paper)
EXPERIMENTALAlgorithm 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 Algorithm 2 (Digital)
EXPERIMENTALAlgorithm 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.
Insulin Degludec
ACTIVE COMPARATORInsulin 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.
Interventions
Eligibility Criteria
You may qualify if:
- Participants must have type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with a stable dose of metformin in combination with a stable dose of Dipeptidyl Peptidase IV (DPPIV) inhibitor and/or a Sodium-glucose co-transporter-2 (SGLT2) inhibitor for at least 3 months prior to screening
- 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
You may not qualify if:
- Have type 1 diabetes mellitus or latent autoimmune diabetes
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (64)
Syed Research Consultants Llc
Sheffield, Alabama, 35660, United States
National Research Institute - Huntington Park
Huntington Park, California, 90255, United States
National Research Institute - Wilshire
Los Angeles, California, 90057, United States
Catalina Research Institute, LLC
Montclair, California, 91763, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
CMR of Greater New Haven
Waterbury, Connecticut, 06708, United States
ALL Medical Research, LLC
Cooper City, Florida, 33024, United States
Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, 33312, United States
Suncoast Research Group
Miami, Florida, 33135, United States
New Horizon Research Center
Miami, Florida, 33165 3338, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
Rophe Adult and Pediatric Medicine
Union City, Georgia, 30291, United States
Elite Clinical Trials
Blackfoot, Idaho, 83221, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404, United States
Elite Clinical Trials
Rexburg, Idaho, 83440, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265, United States
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, 66606, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Endocrine and Metabolic Consultants
Rockville, Maryland, 20852, United States
Sky Clin Resch - Quinn HC
Ridgeland, Mississippi, 39157, United States
Lillestol Research LLC
Fargo, North Dakota, 58104, United States
Intend Research, LLC
Norman, Oklahoma, 73069, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401, United States
Holston Medical Group
Bristol, Tennessee, 37620, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78731-4309, United States
Dallas Diabetes Research Center
Dallas, Texas, 75230, United States
Juno Research
Houston, Texas, 77040, United States
Juno Research - Gessner
Houston, Texas, 77074, United States
Southern Endocrinology Associates
Mesquite, Texas, 75149, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Centro Médico Viamonte
CABA, Buenos Aires, C1120AAC, Argentina
Investigaciones Medicas Imoba Srl
CABA, Buenos Aires, C1179AAB, Argentina
Fundacion Sanatorio Guemes
CABA, Buenos Aires, C1180AAX, Argentina
Consultorio de Investigación Clínica EMO SRL
Caba, Buenos Aires, C1405BUB, Argentina
CEDIC
CABA, Buenos Aires, C1425DES, Argentina
Instituto Médico Catamarca
Rosario, Santa Fe Province, 2000, Argentina
CEMEDIC
Buenos Aires, 1407, Argentina
Asociación de Beneficencia Hospital Sirio Libanés
Buenos Aires, C1419AHN, Argentina
Instituto Centenario
Ciudad Autonoma de Buenos Aire, C1204AAD, Argentina
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
Córdoba, X5008HHW, Argentina
Clínica Mayo
San Miguel de Tucumán, T4000IHE, Argentina
Diabetes- und Stoffwechselpraxis Bochum
Bochum, North Rhine-Westphalia, 44869, Germany
InnoDiab Forschung Gmbh
Essen, North Rhine-Westphalia, 45136, Germany
Institut für Diabetesforschung GmbH Münster
Münster, North Rhine-Westphalia, 48145, Germany
Practice Dr.med. Denger and Dr.med. Pfitzner
Friedrichsthal, Saarland, 66299, Germany
Private Practice - Dr. Christine Kosch
Pirna, Saxony, 01796, Germany
SMO.MD GmbH
Magdeburg, Saxony-Anhalt, 39120, Germany
RED-Institut GmbH
Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany
Diabeteszentrum Hamburg West
Hamburg, 22607, Germany
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
Krakow, Lesser Poland Voivodeship, 31-261, Poland
Instytut Diabetologii Sp. z o.o
Warsaw, Masovian Voivodeship, 02-117, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80-546, Poland
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
Ruda Śląska, Silesian Voivodeship, 41-709, Poland
Centrum Kliniczno-Badawcze
Elblag, 82-300, Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, 90242, Poland
Gabinety TERPA
Lublin, 20-333, Poland
OMEDICA Medical Center
Poznan, 60-111, Poland
Praktyka Lekarska
Poznan, 61-655, Poland
Poradnia Chorob Metabolicznych
Wierzchosławice, 33-122, Poland
NZOZ Regionalna Poradnia Diabetologiczna
Wroclaw, 50-127, Poland
Research and Cardiovascular Corp.
Ponce, PR, 00717, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
San Juan, PR, 00917, Puerto Rico
Centro Profesional de Endocrinologia del Este
Yabucoa, PR, 00767, Puerto Rico
Related Publications (1)
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.
PMID: 36944059DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was initially designed as 3 arms: LY3209590 Algorithm 1 (Paper), LY3209590 Algorithm 2 (Digital), and Insulin Degludec. However, it was amended to terminate the "LY3209590 Algorithm 2 (Digital)" arm during early enrollment phase due to technical issues with data entry. Thus, this arm was excluded from the outcome measure analyses, but safety data was analysed and reported.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2020
First Posted
June 29, 2020
Study Start
July 1, 2020
Primary Completion
October 8, 2021
Study Completion
October 8, 2021
Last Updated
November 2, 2022
Results First Posted
November 2, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.