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

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)

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Insulin Degludec; Drug: Insulin Efsitora Alfa

• Study Type: Interventional
• Enrollment (Actual): 986
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1407
    • CEMEDIC
  • Ciudad Autónoma de Buenos Aire, Argentina, C1440AAD
    • CENUDIAB
  • Córdoba, Argentina, 5000
    • Centro Diabetológico Dr. Waitman
  • Buenos Air
    • Ciudad Autonoma de Buenos Aire, Buenos Air, Argentina, C1405BUB
      • Consultorio de Investigacion Clinica EMO SRL
    • Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina, C1023AAB
      • STAT Research S.A.
  • Buenos Aires
    • Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina, 1056
      • Centro de Investigaciones Metabólicas (CINME)
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Instituto de Investigaciones Clinicas Mar del Plata
    • San Nicolas, Buenos Aires, Argentina, 2900
      • Go Centro Medico San Nicolás
  • Ciudad Aut
    • Buenos Aires, Ciudad Aut, Argentina, C1120AAC
      • Centro Medico Viamonte
    • Buenos Aires, Ciudad Aut, Argentina, C1128AAF
      • Mautalen Salud e Investigación
  • Ciudad Autónoma De Buenos Aire
    • Caba, Ciudad Autónoma De Buenos Aire, Argentina, 1204
      • Instituto Centenario
  • Córdoba
    • Capital, Córdoba, Argentina, X5008HHW
      • Centro Medico Privado CEMAIC
  • Mendoza
    • Godoy Cruz, Mendoza, Argentina, M5501ARP
      • CIPADI - Centro Integral de Prevención y Atención en Diabetes
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Instituto Médico Catamarca IMEC
• Hungary
  • Budapest, Hungary, H1171
    • Strazsahegy Medicina Bt.
  • Budapest, Hungary, 1125
    • Szent János Kórház
  • Budapest, Hungary, 1032
    • Szent Margit Rendelointézet
  • Veszprém
    • Balatonfüred, Veszprém, Hungary, 8230
      • DRC Gyógyszervizsgáló Központ
  • Zala
    • Nagykanizsa, Zala, Hungary, 8800
      • Kanizsai Dorottya Korhaz
    • Zalaegerszeg, Zala, Hungary, 8900
      • Zala Megyei Szent Rafael Kórház
• Japan
  • Kumamoto, Japan, 862-0976
    • Jinnouchi Hospital
  • Miyazaki, Japan, 880-0034
    • Heiwadai Hospital
  • Oita, Japan, 870-0039
    • Abe Clinic
  • Osaka, Japan, 530-0001
    • AMC Nishiumeda Clinic
  • Chiba
    • Mihama-ku,Chiba City, Chiba, Japan, 261-0004
      • Tokuyama Clinic
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-0001
      • Yuri Ono Clinic
  • Ibaraki
    • Mito, Ibaraki, Japan, 310-0826
      • Nakamoto Internal Medicine Clinic
    • Mito, Ibaraki, Japan, 310-0845
      • Kozawa Eye Hospital And Diabetes Center
    • Ushiku, Ibaraki, Japan, 300-1207
      • Noritake Clinic
  • Kanagawa
    • Ebina, Kanagawa, Japan, 243-0432
      • Matoba Internal Medicine Clinic
    • Kamakura-shi, Kanagawa, Japan, 247-0056
      • Takai Internal Medicine Clinic
    • Yamato-shi, Kanagawa, Japan, 242-0004
      • Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
  • Osaka
    • Kashiwara, Osaka, Japan, 582-0005
      • Shiraiwa Medical Clinic
    • Takatsuki, Osaka, Japan, 569-1045
      • Takatsuki Red Cross Hospital
  • Saitama
    • Saitama-shi, Saitama, Japan, 336-0967
      • Shimizu Clinic Fusa
  • Tochigi
    • Oyama, Tochigi, Japan, 323-0022
      • Oyama East Clinic
  • Tokyo
    • Chuo Ku, Tokyo, Japan, 103-0027
      • Tokyo-Eki Center-building Clinic
    • Chuo-ku, Tokyo, Japan, 104-0031
      • Fukuwa Clinic
    • Chuo-ku, Tokyo, Japan, 103-0028
      • Medical Corporation Chiseikai Tokyo Center Clinic
    • Chuo-ku, Tokyo, Japan, 103-0002
      • The Institute of Medical Science, Asahi Life Foundation
• Korea, Republic of
  • Kang-won-do
    • Chuncheon-si, Kang-won-do, Korea, Republic of, 24289
      • Kangwon National University Hospital
    • Wonju, Kang-won-do, Korea, Republic of, 26426
      • Yonsei University-Wonju Severance Christian Hospital
  • Kyǒnggi-do
    • Ansan-si, Kyǒnggi-do, Korea, Republic of, 15355
      • Korea University Ansan Hospital
    • Guri-si, Kyǒnggi-do, Korea, Republic of, 11923
      • Hanyang University Guri Hospital
  • Kyǒngsangbuk-do
    • Gyeongsan-si, Kyǒngsangbuk-do, Korea, Republic of, 42415
      • Yeungnam Univeristy Medical Center
  • Seoul-teuk
    • Seoul, Seoul-teuk, Korea, Republic of, 03722
      • Severance Hospital, Yonsei University Health System
  • Seoul-teukbyeolsi [Seoul]
    • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05505
      • Asan Medical Center
    • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 07441
      • Hallym University Kangnam Sacred Heart Hospital
    • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 01757
      • Inje University Sanggye Paik Hospital
    • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 134-090
      • Kyung Hee University Hospital at Gangdong
    • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03080
      • Seoul National University Hospital
  • Ulsan-Kwangyǒkshi
    • Ulsan, Ulsan-Kwangyǒkshi, Korea, Republic of, 44033
      • Ulsan University Hospital
• Poland
  • Lubelskie
    • Lublin, Lubelskie, Poland, 20-044
      • CenterMed Lublin NZOZ
    • Lublin, Lubelskie, Poland, 20-333
      • Gabinety TERPA
    • Lublin, Lubelskie, Poland, 20-538
      • NZOZ Medica
  • Małopolskie
    • Krakow, Małopolskie, Poland, 31-261
      • NZOZ Diab-Endo-Met
    • Tarnów, Małopolskie, Poland, 33-100
      • Private Practice - Dr. Robert Witek
  • Pomorskie
    • Gdansk, Pomorskie, Poland, 80-546
      • Centrum Badan Klinicznych Pi-House Sp. Z O.O.
  • Wielkopolskie
    • Poznan, Wielkopolskie, Poland, 60-111
      • OMEDICA Medical Center
    • Poznan, Wielkopolskie, Poland, 61-251
      • Gaja Poradnie Lekarskie Maciej Wiza
  • Łódzkie
    • Lodz, Łódzkie, Poland, 90338
      • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
    • Piotrkow Trybunalski, Łódzkie, Poland, 97-300
      • IRMED
  • Śląskie
    • Ruda Slaska, Śląskie, Poland, 41-709
      • NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
• Puerto Rico
  • San Juan, Puerto Rico, 00917
    • GCM Medical Group, PSC - Hato Rey Site
  • San Juan, Puerto Rico, 00921
    • Mgcendo Llc
• Slovakia
  • Bratislava, Slovakia, 84102
    • Diacrin .s.ro.
  • Puchov, Slovakia, 020 01
    • DIA-MED CENTRUM s.r.o.
  • Bratislavský Kraj
    • Malacky, Bratislavský Kraj, Slovakia, 901 01
      • MediVet s.r.o.
  • Košický Kraj
    • Kosice, Košický Kraj, Slovakia, 04012
      • Human Care s.r.o.
    • Trebisov, Košický Kraj, Slovakia, 075 01
      • ARETEUS s.r.o.
  • Prešovský Kraj
    • Sabinov, Prešovský Kraj, Slovakia, 083 01
      • MEDI-DIA s.r.o.
  • Žilinský Kraj
    • Dolny Kubin, Žilinský Kraj, Slovakia, 026 01
      • ENDIAMED s.r.o
• Spain
  • Sevilla, Spain, 41003
    • Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
  • A Coruña [La Coruña]
    • A Coruña, A Coruña [La Coruña], Spain, 15006
      • CHUAC-Complejo Hospitalario Universitario A Coruña
  • Almería
    • Almeria, Almería, Spain, 04009
      • Centro Periferico De Especialidades Bola Azul
  • Andalucía
    • Malaga, Andalucía, Spain, 29010
      • Hospital Universitario Virgen de la Victoria
    • Sevilla, Andalucía, Spain, 41010
      • Hospital Quiron Infanta Luisa
  • Balears [Baleares]
    • Palma de Mallorca, Balears [Baleares], Spain, 07014
      • Clínica Juaneda
  • Barcelona [Barcelona]
    • Barcelona, Barcelona [Barcelona], Spain, 08035
      • Hospital Universitari Vall d'Hebron
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marqués de Valdecilla
  • Sevilla
    • Seville, Sevilla, Spain, 41950
      • Vithas Hospital Sevilla
  • Valenciana, Comunitat
    • Alzira, Valenciana, Comunitat, Spain, 46600
      • Hospital Universitario de La Ribera
    • Valencia, Valenciana, Comunitat, Spain, 46014
      • Hospital General Universitario de Valencia
• Taiwan
  • New Taipei, Taiwan, 24352
    • Fu Jen Catholic University Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taichung
    • Taichung City, Taichung, Taiwan, 402
      • Chung Shan Medical University Hospital
    • Taichung City, Taichung, Taiwan, 407
      • Taichung Veterans General Hospital
  • Tainan
    • Tainan City, Tainan, Taiwan, 71004
      • Chi Mei Medical Center
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Medical Investigations
  • California
    • Concord, California, United States, 94520
      • John Muir Physician Network Research Center
    • Escondido, California, United States, 92025
      • AMCR Institute
    • Huntington Park, California, United States, 90255
      • National Research Institute - Huntington Park
    • La Jolla, California, United States, 92037
      • Scripps Whittier Diabetes Institute
    • Orange, California, United States, 92868
      • Diabetes Associates Medical Group
    • Tustin, California, United States, 92780
      • University Clinical Investigators, Inc.
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research, LLC
  • Florida
    • Hollywood, Florida, United States, 33021
      • Encore Medical Research
    • Miami, Florida, United States, 33165
      • New Horizon Research Center
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research, Inc.
    • Ocoee, Florida, United States, 34761
      • West Orange Endocrinology
  • Georgia
    • Lawrenceville, Georgia, United States, 30046
      • Balanced Life Health Care Solutions/SKYCRNG
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rocky Mountain Clinical Research
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Iowa Diabetes and Endocrinology Research Center
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • L-MARC Research Center
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Endocrine and Metabolic Consultants
  • Michigan
    • Troy, Michigan, United States, 48098
      • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • HealthPartners Institute dba International Diabetes Center
  • Mississippi
    • Fayette, Mississippi, United States, 39069
      • SKY Clinical Research Network Group - Hall
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Clinvest Research LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Palm Research Center Tenaya
  • New York
    • Albany, New York, United States, 12203
      • Albany Medical College, Division of Community Endocrinology
    • New York, New York, United States, 10016
      • NYC Research
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Lillestol Research
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Aventiv Research Inc
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Intend Research, LLC
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
      • Heritage Valley Medical Group, Inc.
    • Philadelphia, Pennsylvania, United States, 19114
      • Jefferson Clinical Research Institute (JCRI)
    • Uniontown, Pennsylvania, United States, 15401
      • Preferred Primary Care Physicians
  • Texas
    • Beaumont, Texas, United States, 77702
      • Gadolin Research
    • Dallas, Texas, United States, 75230
      • Dallas Diabetes Research Center
    • Houston, Texas, United States, 77040
      • Juno Research
    • Houston, Texas, United States, 77043
      • Biopharma Informatic, LLC
    • Mesquite, Texas, United States, 75149
      • Southern Endocrinology Associates
    • Round Rock, Texas, United States, 78681
      • Texas Diabetes & Endocrinology, P.A.
    • Shavano Park, Texas, United States, 78231
      • Consano Clinical Research, LLC
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 500 U/mL - Insulin Efsitora; Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW).	Drug: Insulin Efsitora Alfa; Administered SC; Other Names: LY3209590 and Basal Insulin-FC
Active Comparator: 100 U/mL - Insulin Degludec; Participants received 100 U/mL insulin degludec administered SC once daily (QD).	Drug: Insulin Degludec; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time 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 Measure	Measure Description	Time 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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: 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 - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

Helpful Links

• A Study of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2022
• Primary Completion (Actual): May 15, 2024
• Study Completion (Actual): May 15, 2024

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Physiological Effects of Drugs; Hypoglycemic Agents; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: 18237; I8H-MC-BDCU (Other Identifier: Eli Lilly and Company); 2021-002569-16 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No