beta
Trial Radar AI
One study matched filter criteria
Card View
Back to Search

A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin Phase 3 986

Completed
Clinical Trial NCT05275400 was designed to study Treatment for Type 2 Diabetes. This was a Phase 3 interventional study that is now completed. The study started on March 8, 2022, with plans to enroll 986 participants. Led by Eli Lilly and Company, the expected completion date was May 15, 2024. The latest data from ClinicalTrials.gov was last updated on June 3, 2025.
Brief Summary
The reason for this study is to see if the study drug insulin efsitora alfa (LY3209590) is safe and effective in participants with Type 2 diabetes that have already been treated with basal insulin. The study consists of a 3-week screening/lead-in period, a 78-week treatment period and a 5-week safety follow-up period. The study will last up to 86 weeks.
Official Title

A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin (QWINT-3)

Conditions
Type 2 Diabetes
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • 18237
  • I8H-MC-BDCU (Other Identifier) (Eli Lilly and Company)
  • 2021-002569-16 (EudraCT Number)
NCT ID Number
NCT05275400
Start Date (Actual)
2022-03-08
Last Update Posted
2025-06-03
Completion Date (Estimated)
2024-05-15
Enrollment (Estimated)
986
Study Type
Interventional
PHASE
Phase 3
Status
Completed
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimental500 U/mL - Insulin Efsitora
Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW).
Insulin Efsitora Alfa
Administered SC
Active Comparator100 U/mL - Insulin Degludec
Participants received 100 U/mL insulin degludec administered SC once daily (QD).
Insulin Degludec
Administered SC
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority]
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputation approach.
Baseline, Week 26
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change From Baseline in Hemoglobin A1c (HbA1c) [Superiority]
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputation approach.
Baseline, Week 26
Nocturnal Hypoglycemia Event Rate
The event rate of participant-reported clinically significant glucose \<54 mg/dL (3.0 mmol/L) or severe nocturnal hypoglycemia that occurs at night and presumably during sleep between midnight and 6:00 AM), measured during treatment period up to week 78. Group mean is reported here. Group mean is determined by Negative Binomial Model using Number of episodes = Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.
Baseline up to Week 78
Percentage of Time in Glucose Range Between 70 and 180 mg/dL (3.9 and 10.0 mmol/L)
Percentage of time in glucose range between 70 and 180 mg/dL (3.9 and 10.0 millimoles per liter (mmol/L)) inclusive measured by continued glucose monitoring (CGM) during CGM session prior to week 26. LS Mean was calculated using ANCOVA model with Baseline + Country + Hemoglobin A1c Stratum at Baseline + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data during CGM session prior to Week 26 were imputed by return-to-baseline multiple imputation approach.
Week 22 to Week 26
Change From Baseline in Fasting Glucose
Fasting glucose measured by Self-Monitoring of Blood Glucose (SMBG). LS Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment (Type III sum of squares) as variables. Missing data at baseline are imputed with multiple imputation under assumption of missing at random. Missing data at Week 26 are imputed by return-to-baseline multiple imputation approach.
Baseline, Week 26
Weekly Insulin Dose at Week 26
The average weekly insulin dose at Week 26 was reported. LS Mean was determined by mixed model repeated measures (MMRM) model using BASELINE + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.
Week 26
Hypoglycemia Event Rate
Patient reported events of hypoglycemia - Hypoglycemia with glucose \<54 mg/dL (Level 2) or Severe Hypoglycemia (Level 3) was reported. A severe hypoglycemic event is characterized by altered mental or physical status requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions for the treatment of hypoglycemia. Group mean was reported and determined by Negative binomial method using Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as variables.
Baseline up to Week 78
Change From Baseline in Body Weight
Change from baseline in body weight was reported. LS Mean was determined by MMRM model using BASELINE + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Baseline, Week 78
Percentage of Time in Hypoglycemia Range
Percentage of time in hypoglycemia range with glucose \<54 mg/dL (3.0 mmol/L) measured during CGM from 22-26 weeks. LS Mean was determined using ANCOVA model using Baseline + Country + Hemoglobin A1c Stratum at Baseline + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at baseline were imputed with multiple imputation under assumption of missing at random. Missing data at Week 22-26 were imputed by return-to-baseline multiple imputation approach.
Week 22 to Week 26
Percentage of Time in Hyperglycemia Range
Percentage of time in hyperglycemia range with glucose \>180 mg/dL (10.0 mmol/L) measured during the CGM session from 22-26 weeks. LS Mean was determined using ANCOVA model using Baseline + Country + Hemoglobin A1c Stratum at Baseline + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at baseline were imputed with multiple imputation under assumption of missing at random. Missing data at Week 22-26 were imputed by return-to-baseline multiple imputation approach.
Week 22 to Week 26
Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D)
The TRIM-D is a self-administered instrument, which assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatments. The TRIM-D consists of 28 items each assessed on a 5-point scale. TRIM-D items assess 5 domains of impact: * Treatment Burden (6 items) * Daily Life (5 items) * Diabetes Management (5 items) * Compliance (4 items), and * Psychological Health (8 items) Items within each domain are summed to obtain a raw domain score, which is then transformed to a 0-100 scale, where higher scores indicate a greater impact on participant's functioning and well-being. LS mean was determined using MMRM model with BASELINE + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Baseline, Week 26, Week 52, Week 78
Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 26
DTSQc treatment satisfaction score is a 6-item questionnaire which assesses relative change in overall treatment satisfaction. The treatment satisfaction score ranges from -18 to 18, where higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment.
Week 26
Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 52
DTSQc treatment satisfaction score is a 6-item questionnaire which assesses relative change in overall treatment satisfaction. The treatment satisfaction score ranges from -18 to 18, where higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment.
Week 52
Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 78
DTSQc treatment satisfaction score is a 6-item questionnaire which assesses relative change in overall treatment satisfaction. The treatment satisfaction score ranges from -18 to 18, where higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment.
Week 78
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  • Have been diagnosed with Type 2 diabetes according to the World Health Organization (WHO) criteria treated with basal insulin

  • Are receiving ≥10 units of basal insulin per day and ≤110 units per day at screening

  • Have HbA1c value of 6.5% - 10% inclusive, at screening

  • Have a Body mass index (BMI) less than or equal to 45 kilogram/square meter (kg/m²)

  • Have been treated with one of the following stable insulin regimens at least 90 days prior to screening:

    • once daily U100 or U200 of insulin degludec
    • once daily U100 or U300 of insulin glargine
    • once or twice daily U100 of insulin detemir, or
    • once or twice daily human insulin NPH

  • acceptable non insulin glucose lowering therapies may include 0 to up to 3 of the following:

    • dipeptidyl peptidase (DPP-4) IV inhibitors
    • SGLT2 inhibitors
    • metformin
    • alphaglucosidase inhibitors or,
    • Glucagon-Like Peptide-1 (GLP-1) receptor agonists
    • Participants must be willing to stay on stable dose throughout the study

  • Have Type 1 diabetes mellitus

  • Have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease, except Nonalcoholic Fatty Liver Disease (NAFLD)

  • Estimated glomerular filtration rate (eGFR) <20 milliliters/minute/1.73 square meter (m²)

  • Have active or untreated malignancy

  • Are pregnant

  • Have a significant weight gain or loss the past 3 months

  • Have received anytime in the past 6 months, any of the following insulin therapies:

    • prandial insulin
    • insulin mixtures
    • inhaled insulin
    • U-500 insulin, or
    • continuous subcutaneous insulin infusion therapy

  • Have had any of New York Heart Association Class IV heart failure or any of the following CV conditions in the past 3 months:

    • acute myocardial infarctions
    • cerebrovascular accident (stroke), or
    • coronary bypass surgery

  • Gastrointestinal: have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery (Lap-Band) or sleeve gastrectomy within 1 year prior to screening

Eli Lilly and Company logoEli Lilly and Company362 active studies to explore
No contact data.
127 Study Locations in 10 Countries

Arkansas

Medical Investigations, Little Rock, Arkansas, 72211, United States

California

John Muir Physician Network Research Center, Concord, California, 94520, United States
AMCR Institute, Escondido, California, 92025, United States
National Research Institute - Huntington Park, Huntington Park, California, 90255, United States
Scripps Whittier Diabetes Institute, La Jolla, California, 92037, United States
Diabetes Associates Medical Group, Orange, California, 92868, United States
University Clinical Investigators, Inc., Tustin, California, 92780, United States

Connecticut

Chase Medical Research, LLC, Waterbury, Connecticut, 06708, United States

Florida

Encore Medical Research, Hollywood, Florida, 33021, United States
New Horizon Research Center, Miami, Florida, 33165, United States
Suncoast Clinical Research, Inc., New Port Richey, Florida, 34652, United States
West Orange Endocrinology, Ocoee, Florida, 34761, United States

Georgia

Balanced Life Health Care Solutions/SKYCRNG, Lawrenceville, Georgia, 30046, United States

Idaho

Rocky Mountain Clinical Research, Idaho Falls, Idaho, 83404, United States

Iowa

Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50265, United States

Kentucky

L-MARC Research Center, Louisville, Kentucky, 40213, United States

Maryland

Endocrine and Metabolic Consultants, Rockville, Maryland, 20852, United States

Michigan

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division, Troy, Michigan, 48098, United States

Minnesota

HealthPartners Institute dba International Diabetes Center, Minneapolis, Minnesota, 55416, United States

Mississippi

SKY Clinical Research Network Group - Hall, Fayette, Mississippi, 39069, United States

Missouri

Clinvest Research LLC, Springfield, Missouri, 65807, United States

Nevada

Palm Research Center Tenaya, Las Vegas, Nevada, 89128, United States

New York

Albany Medical College, Division of Community Endocrinology, Albany, New York, 12203, United States
NYC Research, New York, New York, 10016, United States

North Dakota

Lillestol Research, Fargo, North Dakota, 58104, United States

Ohio

Aventiv Research Inc, Columbus, Ohio, 43213, United States

Oklahoma

Intend Research, LLC, Norman, Oklahoma, 73069, United States

Pennsylvania

Heritage Valley Medical Group, Inc., Beaver, Pennsylvania, 15009, United States
Jefferson Clinical Research Institute (JCRI), Philadelphia, Pennsylvania, 19114, United States
Preferred Primary Care Physicians, Uniontown, Pennsylvania, 15401, United States

Texas

Gadolin Research, Beaumont, Texas, 77702, United States
Dallas Diabetes Research Center, Dallas, Texas, 75230, United States
Juno Research, Houston, Texas, 77040, United States
Biopharma Informatic, LLC, Houston, Texas, 77043, United States
Southern Endocrinology Associates, Mesquite, Texas, 75149, United States
Texas Diabetes & Endocrinology, P.A., Round Rock, Texas, 78681, United States
Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States

Washington

Rainier Clinical Research Center, Renton, Washington, 98057, United States

PR

GCM Medical Group, PSC - Hato Rey Site, San Juan, PR, 00917, Puerto Rico
Mgcendo Llc, San Juan, 00921, Puerto Rico

Buenos Aires

Centro de Investigaciones Metabólicas (CINME), Ciudad Autónoma de Buenos Aire, Buenos Aires, 1056, Argentina
Instituto de Investigaciones Clínicas Mar del Plata, Mar del Plata, Buenos Aires, 7600, Argentina
Go Centro Medico San Nicolás, San Nicolás de los Arroyos, Buenos Aires, 2900, Argentina

Buenos Air

Consultorio de Investigación Clínica EMO SRL, Ciudad Autonoma de Buenos Aire, Buenos Air, C1405BUB, Argentina
Stat Research S.A., Ciudad Autónoma de Buenos Aire, Buenos Air, C1023AAB, Argentina

Ciudad Aut

Centro Médico Viamonte, Buenos Aires, Ciudad Aut, C1120AAC, Argentina
Mautalen Salud e Investigación, Buenos Aires, Ciudad Aut, C1128AAF, Argentina

Ciudad Autónoma de Buenos Aire

Instituto Centenario, CABA, Ciudad Autónoma de Buenos Aire, 1204, Argentina

Córdoba Province

Centro Medico Privado CEMAIC, Capital, Córdoba Province, X5008HHW, Argentina

Mendoza Province

CIPADI - Centro Integral de Prevencion y Atencion en Diabetes, Godoy Cruz, Mendoza Province, M5501ARP, Argentina

Santa Fe Province

Instituto Médico Catamarca IMEC, Rosario, Santa Fe Province, 2000, Argentina
CEMEDIC, Buenos Aires, 1407, Argentina
CENUDIAB, Ciudad Autónoma de Buenos Aire, C1440AAD, Argentina
Centro Diabetológico Dr. Waitman, Córdoba, 5000, Argentina

Veszprém megye

DRC Gyógyszervizsgáló Központ, Balatonfüred, Veszprém megye, 8230, Hungary

Zala County

Kanizsai Dorottya Korhaz, Nagykanizsa, Zala County, 8800, Hungary
Zala Megyei Szent Rafael Kórház, Zalaegerszeg, Zala County, 8900, Hungary
Szent Margit Rendelointézet, Budapest, 1032, Hungary
Szent János Kórház, Budapest, 1125, Hungary
Strazsahegy Medicina Bt., Budapest, H1171, Hungary

Chiba

Tokuyama Clinic, Mihama-ku,Chiba City, Chiba, 261-0004, Japan

Hokkaido

Yuri Ono Clinic, Sapporo, Hokkaido, 060-0001, Japan

Ibaraki

Nakamoto Internal Medicine Clinic, Mito, Ibaraki, 310-0826, Japan
Kozawa Eye Hospital and Diabetes Center, Mito, Ibaraki, 310-0845, Japan
Noritake Clinic, Ushiku, Ibaraki, 300-1207, Japan

Kanagawa

Matoba Internal Medicine Clinic, Ebina, Kanagawa, 243-0432, Japan
Takai Internal Medicine Clinic, Kamakura-shi, Kanagawa, 247-0056, Japan
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic, Yamato-shi, Kanagawa, 242-0004, Japan

Osaka

Shiraiwa Medical Clinic, Kashihara, Osaka, 582-0005, Japan
Takatsuki Red Cross Hospital, Takatsuki, Osaka, 569-1045, Japan

Saitama

Shimizu Clinic Fusa, Saitama-shi, Saitama, 336-0967, Japan

Tochigi

Oyama East Clinic, Oyama, Tochigi, 323-0022, Japan

Tokyo

Tokyo-Eki Center-building Clinic, Chuo Ku, Tokyo, 103-0027, Japan
The Institute of Medical Science, Asahi Life Foundation, Chuo-ku, Tokyo, 103-0002, Japan
Medical Corporation Chiseikai Tokyo Center Clinic, Chuo-ku, Tokyo, 103-0028, Japan
Fukuwa Clinic, Chuo-ku, Tokyo, 104-0031, Japan
Jinnouchi Hospital, Kumamoto, 862-0976, Japan
Heiwadai Hospital, Miyazaki, 880-0034, Japan
AMC Nishiumeda Clinic, Osaka, 530-0001, Japan
Abe Clinic, Ōita, 870-0039, Japan

Greater Poland Voivodeship

OMEDICA Medical Center, Poznan, Greater Poland Voivodeship, 60-111, Poland
Gaja Poradnie Lekarskie Maciej Wiza, Poznan, Greater Poland Voivodeship, 61-251, Poland

Lesser Poland Voivodeship

NZOZ Diab-Endo-Met, Krakow, Lesser Poland Voivodeship, 31-261, Poland
Private Practice - Dr. Robert Witek, Tarnów, Lesser Poland Voivodeship, 33-100, Poland

Lublin Voivodeship

CenterMed Lublin NZOZ, Lublin, Lublin Voivodeship, 20-044, Poland
Gabinety TERPA, Lublin, Lublin Voivodeship, 20-333, Poland
NZOZ Medica, Lublin, Lublin Voivodeship, 20-538, Poland

Pomeranian Voivodeship

Centrum Badan Klinicznych PI-House sp. z o.o., Gdansk, Pomeranian Voivodeship, 80-546, Poland

Silesian Voivodeship

NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki, Ruda Śląska, Silesian Voivodeship, 41-709, Poland

Łódź Voivodeship

Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna, Lodz, Łódź Voivodeship, 90338, Poland
IRMED, Piotrkow Trybunalski, Łódź Voivodeship, 97-300, Poland

Bratislava Region

MediVet s.r.o., Malacky, Bratislava Region, 901 01, Slovakia

Košice Region

Human Care s.r.o., Košice, Košice Region, 04012, Slovakia
Areteus s.r.o., Trebišov, Košice Region, 075 01, Slovakia

Presov

MEDI-DIA s.r.o., Sabinov, Presov, 083 01, Slovakia
Diacrin .s.ro., Bratislava, 84102, Slovakia
DIA-MED CENTRUM s.r.o., Púchov, 020 01, Slovakia

Žilina Region

ENDIAMED s.r.o, Dolný Kubín, Žilina Region, 026 01, Slovakia

Kang-won-do

Kangwon National University Hospital, Chuncheon, Kang-won-do, 24289, South Korea
Yonsei University-Wonju Severance Christian Hospital, Wŏnju, Kang-won-do, 26426, South Korea

Kyǒnggi-do

Korea University Ansan Hospital, Ansan-si, Kyǒnggi-do, 15355, South Korea
Hanyang University Guri Hospital, Guri-si, Kyǒnggi-do, 11923, South Korea

Kyǒngsangbuk-do

Yeungnam Univeristy Medical Center, Gyeongsan-si, Kyǒngsangbuk-do, 42415, South Korea

Seoul-teukbyeolsi [Seoul]

Inje University Sanggye Paik Hospital, Seoul, Seoul-teukbyeolsi [Seoul], 01757, South Korea
Seoul National University Hospital, Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea
Asan Medical Center, Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea
Hallym University Kangnam Sacred Heart Hospital, Seoul, Seoul-teukbyeolsi [Seoul], 07441, South Korea
Kyung Hee University Hospital at Gangdong, Seoul, Seoul-teukbyeolsi [Seoul], 134-090, South Korea

Seoul-teuk

Severance Hospital, Yonsei University Health System, Seoul, Seoul-teuk, 03722, South Korea

Ulsan-Kwangyǒkshi

Ulsan University Hospital, Ulsan, Ulsan-Kwangyǒkshi, 44033, South Korea

A Coruña [La Coruña]

CHUAC-Complejo Hospitalario Universitario A Coruña, A Coruña, A Coruña [La Coruña], 15006, Spain

Almería

Centro Periférico de Especialidades Bola Azul, Almería, Almería, 04009, Spain

Andalusia

Hospital Universitario Virgen de la Victoria, Málaga, Andalusia, 29010, Spain
Hospital Quiron Infanta Luisa, Seville, Andalusia, 41010, Spain

Balears [Baleares]

Clínica Juaneda, Palma de Mallorca, Balears [Baleares], 07014, Spain

Barcelona [Barcelona]

Hospital Universitari Vall d'Hebron, Barcelona, Barcelona [Barcelona], 08035, Spain

Cantabria

Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, 39008, Spain

Sevilla

Vithas Hospital Sevilla, Seville, Sevilla, 41950, Spain

Valenciana, Comunitat

Hospital Universitario de La Ribera, Alzira, Valenciana, Comunitat, 46600, Spain
Hospital General Universitario de Valencia, Valencia, Valenciana, Comunitat, 46014, Spain
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE), Seville, 41003, Spain

Taichung

Chung Shan Medical University Hospital, Taichung, Taichung, 402, Taiwan
Taichung Veterans General Hospital, Taichung, Taichung, 407, Taiwan

Tainan

Chi Mei Medical Center, Tainan, Tainan, 71004, Taiwan
Fu Jen Catholic University Hospital, New Taipei City, 24352, Taiwan
National Cheng Kung University Hospital, Tainan, 704, Taiwan
Taipei Veterans General Hospital, Taipei, 11217, Taiwan