A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-2)

A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Degludec in Insulin Naïve Adults With Type 2 Diabetes

The purpose of this study is to determine the effect and safety of insulin efsitora alfa (LY3209590) compared to degludec in adult participants with type 2 diabetes who are starting basal insulin for the first time. The study consists of a 1-week screening period, a 2-week lead-in period, a 52-week treatment period, and a 5-week safety follow-up period. The study will last up to 60 weeks.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 928
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 22061-080
    • Hospital São Lucas de Copacabana
  • Sao Paulo, Brazil, 01228-200
    • CPCLIN
  • São Paulo, Brazil, 01228-000
    • CPQuali Pesquisa Clínica
  • São Paulo, Brazil, 04266-010
    • CEPIC - Centro Paulista de Investigação Clínica
  • Espírito Santo
    • Vitória, Espírito Santo, Brazil, 29055450
      • CEDOES
  • Paraná
    • Curitiba, Paraná, Brazil, 80030-480
      • Cline Research Center
  • São Paulo
    • Campinas, São Paulo, Brazil, 13034-685
      • Centro de Pesquisa Sao Lucas
• Canada
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • Aggarwal and Associates Limited
    • Brampton, Ontario, Canada, L6S 0C6
      • LMC Diabetes & Endocrinology
    • Ottawa, Ontario, Canada, K2J 0V2
      • LMC Manna Research
    • Sarnia, Ontario, Canada, N7T 4X3
      • Bluewater Clinical Research Group Inc.
    • Toronto, Ontario, Canada, M9R 4E1
      • Centricity Research Etobicoke Endocrinology
    • Waterloo, Ontario, Canada, N2J 1C4
      • Fadia El Boreky Medicine
  • Quebec
    • Montreal, Quebec, Canada, H4N 2W2
      • 9109-0126 Quebec Inc.
• China
  • Beijing
    • Beijing, Beijing, China, 101200
      • Beijing Pinggu District Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 400014
      • Chongqing General Hospital
  • Hebei
    • Hengshui Shi, Hebei, China, 053000
      • Hebei Medical University - Harrison International Peace Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • The First Hospital of Harbin Medical University
    • Harbin, Heilongjiang, China, 150001
      • The Fourth Hospital of Harbin Medical University
  • Henan
    • Luoyang Shi, Henan, China, 471003
      • The First Affiliated Hospital of Henan University of Science &Technology
    • Zhengzhou, Henan, China, 450014
      • The Second Affiliated Hospital of Zhengzhou University
  • Hunan
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital of Central South University
    • Yueyang, Hunan, China, 414000
      • The First People's Hospital of Yueyang
  • Jiangsu
    • Changzhou, Jiangsu, China, 213164
      • Changzhou No.2 People's Hospital
    • Nanjing, Jiangsu, China, 210011
      • The Second Affiliated Hospital of Nanjing Medical University
    • Nanjing, Jiangsu, China, 211100
      • Nanjing Medical University - Nanjing Jiangning Hospital
    • Nanjing Shi, Jiangsu, China, 210012
      • Nanjing First Hospital
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University
    • Wuxi, Jiangsu, China, 214023
      • Wuxi People's Hospital
    • Wuxi Shi, Jiangsu, China, 214400
      • The Affiliated Jiangyin Hospital of Southeast University Medical College
    • Zhenjiang, Jiangsu, China, 212000
      • Affiliated Hospital of Jiangsu University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330009
      • The Third Hospital of Nanchang
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200062
      • Shanghai Putuo District Center Hospital
  • Sichuan
    • Cheng Du, Sichuan, China, 610041
      • West China Hospital of Sichuan University
    • Chengdu, Sichuan, China, 611130
      • Chengdu Fifth People's Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Tianjin Medical University General Hospital
    • Tianjin, Tianjin, China, 300070
      • Tianjin Medical University Zhu Xianyi Memorial Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310013
      • Zhejiang Hospital
    • Ningbo, Zhejiang, China, 315010
      • Ningbo First Hospital
• Czechia
  • Chrudim
    • Chrudim III, Chrudim, Czechia, 537 01
      • INTENDIA klinika s.r.o.
  • Jihočeský
    • Ceske Budejovice, Jihočeský, Czechia, 37011
      • MUDr. Alena Vachova
  • Moravskoslezský Kraj
    • Krnov, Moravskoslezský Kraj, Czechia, 79401
      • MUDr. Tomas Edelsberger
  • Pardubice
    • Pardubice V, Pardubice, Czechia, 530 02
      • Diahelp s.r.o
  • Praha 4
    • Praha, Praha 4, Czechia, 14900
      • Milan Kvapil s.r.o., Diabetologicka ambulance
  • Praha-vých
    • Brandys nad Labem, Praha-vých, Czechia, 25001
      • Diacentrum Brandys n.L. s.r.o.
  • Rychnov Nad Kněžnou
    • Opocno, Rychnov Nad Kněžnou, Czechia, 517 73
      • MUDr. Tomas Hrdina
• Germany
  • Hamburg, Germany, 22607
    • Diabeteszentrum Hamburg West
  • Baden-Württemberg
    • Wangen im Allgäu, Baden-Württemberg, Germany, 88239
      • Praxis Sauter & Sauter & Vorbach
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45136
      • InnoDiab Forschung Gmbh
    • Essen, Nordrhein-Westfalen, Germany, 45355
      • Medizentrum Essen Borbeck
  • Rheinland-Pfalz
    • Ludwigshafen am Rhein, Rheinland-Pfalz, Germany, 67059
      • Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz
  • Saarland
    • Saint Ingbert, Saarland, Germany, 66386
      • Zentrum für klinische Studien
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • Universitaetsklinikum Carl Gustav Carus Dresden
  • Schleswig-Holstein
    • Oldenburg, Schleswig-Holstein, Germany, 23758
      • Red-Institut GmbH
• Greece
  • Athens, Greece, 115 21
    • Athens Euroclinic
  • Attikí
    • Athens, Attikí, Greece, 11528
      • Alexandra Hospital
  • Attikí (Region)
    • Paleo Faliro, Attikí (Region), Greece, 17562
      • Iatriko Paleou Falirou Medical Center
  • Thessaloníki
    • Thessaloniki, Thessaloníki, Greece, 570 01
      • Thermi Clinic
• Japan
  • Kumamoto, Japan, 861-8039
    • Yoshimura Clinic
  • Oita, Japan, 870-0039
    • Abe Clinic
  • Aichi
    • Nagoya-shi, Aichi, Japan, 468-0009
      • Tosaki Clinic for Diabetes and Endocrinology
  • Chiba
    • Kashiwa, Chiba, Japan, 277-0825
      • Kashiwa City Hospital
    • Mihama-ku,Chiba City, Chiba, Japan, 261-0004
      • Tokuyama Clinic
  • Hiroshima
    • Fukuyama-shi, Hiroshima, Japan, 721-0927
      • Nippon Kokan Fukuyama Hospital
  • Hokkaido
    • Chitose, Hokkaido, Japan, 066-0032
      • Hasegawa Medical Clinic
    • Sapporo, Hokkaido, Japan, 060-0062
      • Manda Memorial Hospital
  • Ibaraki
    • Mito, Ibaraki, Japan, 311-4153
      • MinamiAkatsukaClinic
    • Naka, Ibaraki, Japan, 311-0113
      • Nakakinen Clinic
  • Kanagawa
    • Chigasaki, Kanagawa, Japan, 253-0044
      • Hayashi Diabetes Internal Medicine Clinic
    • Yamato-shi, Kanagawa, Japan, 242-0004
      • Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
  • Saitama
    • Saitama-shi, Saitama, Japan, 336-0967
      • Shimizu Clinic Fusa
  • Tokyo
    • Arakawa-ku, Tokyo, Japan, 116-0012
      • Kumanomae Nishimura Clinic
    • Chuo-ku, Tokyo, Japan, 104-0031
      • Fukuwa Clinic
    • Hachioji-shi, Tokyo, Japan, 192-0083
      • Hachioji Diabetes Clinic
    • Ootaku, Tokyo, Japan, 143-0015
      • Medical Corporation Sato Medical clinic
    • Shinjuku, Tokyo, Japan, 160-0022
      • Tomonaga Clinic
• Korea, Republic of
  • Kang-won-do
    • Chuncheon-si, Kang-won-do, Korea, Republic of, 24289
      • Kangwon National University Hospital
  • Kyǒnggi-do
    • Guri-si, Kyǒnggi-do, Korea, Republic of, 11923
      • Hanyang University Guri Hospital
  • Seoul-teuk
    • Seoul, Seoul-teuk, Korea, Republic of, 03722
      • Severance Hospital, Yonsei University Health System
• Mexico
  • Chihuahua, Mexico, 31217
    • Investigacion En Salud Y Metabolismo Sc
• Puerto Rico
  • Caguas, Puerto Rico, 00725
    • Centro de Endocrinologia y Nutricion
  • Guaynabo, Puerto Rico, 00970
    • Private Practice - Dr. Paola Mansilla-Letelier
• United States
  • California
    • Escondido, California, United States, 92025
      • Neighborhood Healthcare Institute of Health
    • Fresno, California, United States, 93720
      • Valley Research
    • Greenbrae, California, United States, 94904
      • NorCal Medical Research, Inc
    • Montclair, California, United States, 91763
      • Catalina Research Institute, LLC
    • Santa Ana, California, United States, 92701
      • Southern California Dermatology, Inc.
  • Colorado
    • Golden, Colorado, United States, 80401
      • New West Physicians Clinical Research
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • New England Research Associates, LLC
  • Florida
    • Jacksonville, Florida, United States, 32204
      • East Coast Institute for Research, LLC
  • Georgia
    • Canton, Georgia, United States, 30114
      • East Coast Institute for Research - Canton
    • Union City, Georgia, United States, 30291
      • Rophe Adult and Pediatric Medicine/SKYCRNG
  • Illinois
    • Springfield, Illinois, United States, 62711
      • Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
  • Indiana
    • Evansville, Indiana, United States, 47715
      • Qualmedica Research, LLC
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Iowa Diabetes and Endocrinology Research Center
  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
      • Qualmedica Research
  • Maryland
    • Hyattsville, Maryland, United States, 20782
      • MedStar Health Research Institute (MedStar Physician Based Research Network)
    • Rockville, Maryland, United States, 20852
      • Endocrine and Metabolic Consultants
  • Mississippi
    • Ridgeland, Mississippi, United States, 39157
      • SKY Clinical Research Network Group-Quinn
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Clinvest Research LLC
  • New York
    • East Syracuse, New York, United States, 13057
      • Clarity Clinical Research
    • Westfield, New York, United States, 14787
      • Great Lakes Medical Research, LLC
  • North Carolina
    • Monroe, North Carolina, United States, 28112
      • Monroe Biomedical Research
    • Morehead City, North Carolina, United States, 28557
      • Lucas Research, Inc
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Intend Research, LLC
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Jefferson Clinical Research Institute (JCRI)
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Tribe Clinical Research, LLC
  • Texas
    • Dallas, Texas, United States, 75230
      • Dallas Diabetes Research Center
    • Houston, Texas, United States, 77040
      • Juno Research
    • Mesquite, Texas, United States, 75149
      • Southern Endocrinology Associates
    • North Richland Hills, Texas, United States, 76180
      • North Hills Family Medicine/North Hills Medical Research
  • Washington
    • Spokane, Washington, United States, 99202
      • MultiCare Institute for Research and Innovation

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Have diagnosis of Type 2 diabetes (T2D) according to the World Health Organization Criteria
• Have an Hemoglobin A1c (HbA1c) of 7.0 percent (%) - 10.5% inclusive, at screening
• Are on a stable treatment with 1 to 3 antihyperglycemic medication for at least 3 months prior to screening and willing to continue the stable treatment for the duration of the study

• These antihyperglycemic medications are accepted in the study

  • dipeptidyl peptidase-4 (DPP-4) inhibitors
  • sodium-glucose cotransporter 2 (SGLT2) inhibitors
  • biguanides, such as metformin
  • alpha-glucosidase inhibitors
  • glucagon-like peptide-1 (GLP-1) receptor agonists, oral or injectable
  • Sulfonylureas, or
  • Thiazolidinediones.
• Are insulin naïve.

Exceptions:

• short-term insulin treatment for a maximum of 14 days, prior to screening, and prior insulin treatment for gestational diabetes

  • Have a body mass index of less than or equal to (≤) 45 kilogram/square meter (kg/m²).

Exclusion Criteria:

• Have a diagnosis of Type 1 diabetes (T1D), latent autoimmune diabetes, or a specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug-induced or chemical-induced diabetes.
• Have a history of greater than (>) 1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening. Have had severe hypoglycemia episodes within 6 months prior to screening. Have a history of renal transplantation, are currently receiving renal dialysis, or have an estimated glomerular filtration rate.
• Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.

• Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening

  • Acute myocardial infarction
  • Cerebrovascular accident (stroke), or
  • Coronary bypass surgery.
  • Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening
  • Have had significant weight gain or loss within 3 months prior to screening, for example, greater than or equal to (≥) 5%.

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 Alfa; Participants received 500 units per milliliter (U/mL) of insulin efsitora alfa administered subcutaneously (SC) once weekly (QW) over a 52-week treatment period, followed by a 5-week safety follow-up period.; Participants continued their protocol-specified stable therapy with non-insulin antihyperglycemic medications throughout the study, at the discretion of the investigator.	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) over a 52-week treatment period, followed by a 5-week safety follow-up period.; Participants continued their protocol-specified stable therapy with non-insulin antihyperglycemic medications throughout the study, at the discretion of the investigator.	Drug: Insulin Degludec; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in HbA1c at Week 52 [Noninferiority Analysis]	HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.; Least Squares (LS) mean was determined using Analysis of Covariance (ANCOVA) model with Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputations approach.	Baseline, Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in HbA1c at Week 52 in Participants Using GLP-1 Receptor Agonists [Noninferiority Analysis]	HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.; LS mean was determined using ANCOVA model with Baseline + Country + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputations approach.	Baseline, Week 52
Change From Baseline in HbA1c at Week 52 in Participants Not Using GLP-1 Receptor Agonists [Noninferiority Analysis]	HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.; LS mean was determined using ANCOVA model with Baseline + Country + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputations approach.	Baseline, Week 52
Change From Baseline in HbA1c at Week 52 [Superiority Analysis]	HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.; LS mean was determined using ANCOVA model with Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputations approach.	Baseline, Week 52
Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] - Week 48 to Week 52	Percentage of time spent within the blood glucose range of 70 to 180 milligrams per deciliter (mg/dL) [3.9 to 10.0 millimoles per liter (mmol/L)], as measured during the continuous glucose monitoring (CGM) session over a 24-hour period, from Week 48 to Week 52.; LS mean was determined using ANCOVA model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization + SU Use at Randomization + Treatment (Type III sum of squares) as variables. Missing data at baseline were imputed using multiple imputation under the assumption of missing at random, while missing data at Week 48-52 were imputed using a return-to-baseline multiple imputation approach.	Week 48 to Week 52
Change From Baseline in HbA1c at Week 26 [Superiority Analysis]	HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.; LS mean was determined using ANCOVA model with Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach.	Baseline, Week 26
Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] - Week 22 to Week 26	Percentage of time spent within the blood glucose range of 70 to 180 mg/dL (3.9 to 10.0 mmol/L), as measured during the CGM session over a 24-hour period, from Week 22 to Week 26.; LS mean was determined using ANCOVA model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization + SU Use at Randomization + Treatment (Type III sum of squares) as variables. Missing data at baseline were imputed using multiple imputation under the assumption of missing at random, while missing data at Week 22-26 were imputed using a return-to-baseline multiple imputation approach.	Week 22 to Week 26
Change From Baseline in Fasting Blood Glucose (FBG)	Change from baseline in fasting blood glucose measured by self-monitoring blood glucose (SMBG).	Baseline, Week 26, Week 52
Glucose Variability	Glucose variability measured as coefficient of variation (CV) for blood glucose during the CGM session over a 24-hour period, between Week 22 to Week 26 and Week 48 to Week 52 was reported.; LS mean was determined using Mixed Model Repeated Measures (MMRM) model with Baseline + Country +HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.	Week 22 to Week 26 and Week 48 to Week 52
Basal Insulin Dose	The insulin dose was calculated based on the participant's entry of daily or weekly insulin doses in an electronic diary. The average weekly basal insulin dose at Week 26 and Week 52 was reported.; LS mean was determined using MMRM model with Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.	Week 26 and Week 52
Hypoglycemia Event Rate	A hypoglycemic event with blood glucose (BG) levels of less than (<) 54 mg/dL (3.0 mmol/L) [Level 2] or Severe Hypoglycemia [Level 3] was reported. A severe hypoglycemic event was characterized by altered mental or physical status, requiring the 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 model using Number of episodes = HbA1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.	Baseline up to Week 52
Nocturnal Hypoglycemia Event Rate	The event rate of participant-reported clinically significant nocturnal hypoglycemia (defined as blood glucose level <54 mg/dL (3.0 mmol/L) or severe hypoglycemia and occurs at night and presumably during sleep between midnight and 6:00 AM), measured during treatment phase up to week 52.; Group mean was reported and determined by Negative binomial model using Number of episodes = HbA1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.	Baseline up to Week 52
Change From Baseline in Body Weight	Change from baseline in body weight was reported. LS mean was determined by MMRM model with Baseline + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.	Baseline, Week 26, Week 52
Percentage of Time in Hypoglycemia Range With Blood Glucose <70 mg/dL (3.9 mmol/L)	Percentage of time spent in the hypoglycemia range with blood glucose <70 mg/dL (3.9 mmol/L), as measured during the CGM session over a 24-hour period from Week 8 to Week 12, Week 22 to Week 26, and Week 48 to Week 52 was reported.; LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.	Week 8 to Week 12, Week 22 to Week 26 and Week 48 to Week 52
Percentage of Time in Hypoglycemia Range With Blood Glucose <54 mg/dL (3.0 mmol/L)	Percentage of time spent in the hypoglycemia range with blood glucose < 54 mg/dL (3.0 mmol/L), as measured during the CGM session over a 24-hour period from Week 8 to Week 12, Week 22 to Week 26, and Week 48 to Week 52, was reported.; LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.	Week 8 to Week 12, Week 22 to Week 26 and Week 48 to Week 52
Percentage of Time in Hyperglycemia Range With Blood Glucose >180 mg/dL (10.0 mmol/L)	Percentage of time spent in the hyperglycemia range with blood glucose greater than (>) 180 mg/dL (10.0 mmol/L), as measured during the CGM session over a 24-hour period from Week 8 to Week 12, Week 22 to Week 26, and Week 48 to Week 52 was reported.; LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.	Week 8 to Week 12, Week 22 to Week 26 and Week 48 to Week 52
Change From Baseline in Treatment-Related Impact Measures for Diabetes (TRIM-D) -Total Score at Week 26 and Week 52	The TRIM-D is a participant-reported measure designed to assess the impact of diabetes treatment on individuals' functioning and well-being across different diabetes treatments. The questionnaire includes 28 items grouped into 5 sub-domains: treatment burden, daily life, diabetes management, compliance, and psychological health. Each item is assessed on a 5-point scale, with higher scores indicating better health status. All items were summed to obtain a total raw score, which was transformed to a scale of 0 to 100 to obtain a total score. The total score range is 0-100, with a higher total score indicating better overall health and well-being, while a lower total score indicates worse health or well-being.; LS mean was determined using MMRM model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.	Baseline, Week 26, Week 52
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical-Component and Mental-Component) Scores at Week 26 and Week 52	The SF-36v2 is a participant-reported measure designed to assess health status using 36 items across 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Each domain is scored individually, and information from these 8 domains is further aggregated into 2 health component summary scores, the Physical Component Summary and Mental Component Summary. Scoring of each domain and both summary scores are norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.	Baseline, Week 26, Week 52
Change From Baseline in EuroQuality of Life (EuroQol) - 5 Dimensions-5 Levels (EQ-5D-5L) Health State Index and EQ Visual Analog Scale (VAS) Scores at Week 26 and Week 52	The EQ-5D-5L is a multidimensional, health-related, quality-of-life instrument. It includes 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that are assessed at 5 levels of response (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems). The scores in the 5 dimensions were summarized into a health state index score. A single health-state index value was derived, which ranges from less than 0 (health state equivalent to death, negative values are valued as worse than death) to 1 (perfect health). The EQ VAS rates the participants' perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). This score provides a composite picture of the respondent's health status.	Baseline, Week 26, Week 52

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 to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-2)

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2022
• Primary Completion (Actual): April 10, 2024
• Study Completion (Actual): April 10, 2024

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 5, 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: 18262; I8H-MC-BDCX (Other Identifier: Eli Lilly and Company); 2021-005891-21 (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; CSR

Drug and device information, study documents

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