A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy (QWINT-5)

A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy

The main purpose of this study is to measure the safety and efficacy of insulin efsitora alfa (LY3209590) compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy.

Study Overview

• Status: Completed
• Conditions: Diabetes; Type 1 Diabetes
• Intervention / Treatment: Drug: Insulin Degludec; Drug: Insulin Efsitora Alfa

• Study Type: Interventional
• Enrollment (Actual): 692
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1405
    • Instituto Médico Especializado (IME)
  • Córdoba, Argentina, 5000
    • Centro Diabetológico Dr. Waitman
  • Buenos Air
    • Ciudad Autonoma de Buenos Aire, Buenos Air, Argentina, C1405BUB
      • Consultorio de Investigacion Clinica EMO SRL
    • Moron, Buenos Air, Argentina, B1708EPE
      • CIAD Moron
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1060ABN
      • CEDIC
    • Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina, 1056
      • Centro de Investigaciones Metabólicas (CINME)
  • Ciudad Autónoma De Buenos Aire
    • Balvanera, Ciudad Autónoma De Buenos Aire, Argentina, C1056ABH
      • Investigaciones Medicas IMOBA SRL
    • Buenos Aires, Ciudad Autónoma De Buenos Aire, Argentina, C1128AAF
      • Mautalen Salud e Investigación
  • Córdoba
    • Capital, Córdoba, Argentina, X5008HHW
      • Centro Medico Privado CEMAIC
    • Cordoba, Córdoba, Argentina, 5006
      • Centro Medico Privado San Vicente Diabetes
  • La Pampa
    • Santa Rosa, La Pampa, Argentina, 6300
      • Centro de Salud e Investigaciones Médicas
  • Mendoza
    • Godoy Cruz, Mendoza, Argentina, M5501ARP
      • CIPADI - Centro Integral de Prevención y Atención en Diabetes
  • Tucumán
    • San Miguel De Tucumán, Tucumán, Argentina, T4000AXL
      • Centro Médico Privado de Reumatología
    • San Miguel de Tucuman, Tucumán, Argentina, 4000
      • Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
• Japan
  • Fukuoka, Japan, 815-0071
    • Clinic Masae Minami
  • Kumamoto, Japan, 862-0976
    • Jinnouchi Hospital
  • Miyazaki, Japan, 880-0034
    • Heiwadai Hospital
  • Oita, Japan, 870-0039
    • Abe Clinic
  • Aichi
    • Nagoya-shi, Aichi, Japan, 468-0009
      • Tosaki Clinic for Diabetes and Endocrinology
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-0062
      • Manda Memorial Hospital
  • Ibaraki
    • Mito, Ibaraki, Japan, 311-4153
      • MinamiAkatsukaClinic
    • Naka, Ibaraki, Japan, 311-0113
      • Nakakinen clinic
    • Ushiku, Ibaraki, Japan, 300-1207
      • Noritake Clinic
  • Kanagawa
    • Kamakura-shi, Kanagawa, Japan, 247-0056
      • Takai Internal Medicine Clinic
  • Osaka
    • Takatsuki, Osaka, Japan, 569-1045
      • Takatsuki Red Cross Hospital
  • Saitama
    • Saitama-shi, Saitama, Japan, 336-0967
      • Shimizu Clinic Fusa
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 103-0002
      • The Institute for Adult Disease, Asahi Life Foundation
    • Hachioji-shi, Tokyo, Japan, 192-0083
      • Hachioji Diabetes Clinic
• Poland
  • Lubelskie
    • Lublin, Lubelskie, Poland, 20-333
      • Gabinety TERPA
    • Lublin, Lubelskie, Poland, 20-538
      • NZOZ Medica
  • Mazowiecki
    • Warszawa, Mazowiecki, Poland, 00-710
      • NBR Polska
  • Mazowieckie
    • Radom, Mazowieckie, Poland, 26-600
      • Centrum Medyczne "Diabetika"
    • Warszawa, Mazowieckie, Poland, 02-507
      • Centralny Szpital Kliniczny MSWiA w Warszawie
  • Małopolskie
    • Krakow, Małopolskie, Poland, 31-261
      • Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-404
      • SN ZOZ Lege Artis Poradnia Diabetologiczna
    • Bialystok, Podlaskie, Poland, 15-435
      • NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny
  • Pomorskie
    • Gdansk, Pomorskie, Poland, 80-546
      • Centrum Badan Klinicznych PI-House sp. z o.o.
  • Śląskie
    • Zabrze, Śląskie, Poland, 41-800
      • Private Practice - Dr. Janusz Gumprecht
• Puerto Rico
  • Bayamon, Puerto Rico, 00959
    • Advanced Clinical Research, LLC
  • San Juan, Puerto Rico, 921
    • Endocrinologist Metabolic Clinic & Research Institute
• Slovakia
  • Košický Kraj
    • Rožňava, Košický Kraj, Slovakia, 04801
      • Tatratrial s.r.o.
  • Nitriansky Kraj
    • Nove Zamky, Nitriansky Kraj, Slovakia, 940 01
      • Funkystuff
  • Žilinský Kraj
    • Dolny Kubin, Žilinský Kraj, Slovakia, 026 01
      • ENDIAMED s.r.o
• Taiwan
  • Changhua, Taiwan, 50006
    • Changhua Christian Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University 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
  • Taipei
    • Taipei City, Taipei, Taiwan, 11217
      • Taipei Veterans General Hospital
• United States
  • California
    • Concord, California, United States, 94520
      • John Muir Physician Network Research Center
    • Fresno, California, United States, 93720
      • Valley Research
    • Montclair, California, United States, 91763
      • Catalina Research Institute, LLC
    • Santa Barbara, California, United States, 93105
      • Sansum Diabetes Research Institute
    • Tustin, California, United States, 92780
      • University Clinical Investigators, Inc.
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus
  • Florida
    • Fleming Island, Florida, United States, 32003
      • Northeast Research Institute (NERI)
    • Fort Lauderdale, Florida, United States, 33312
      • Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research, Inc.
    • Port Charlotte, Florida, United States, 33952
      • Hanson Clinical Research Center
  • Georgia
    • Macon, Georgia, United States, 31210
      • East Coast Institute for Research at The Jones Center
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • East-West Medical Research Institute
  • 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
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Clinical Research Center
  • Maryland
    • Hyattsville, Maryland, United States, 20782
      • MedStar Health Research Institute (MedStar Physician Based Research Network)
    • Rockville, Maryland, United States, 20852
      • Endocrine and Metabolic Consultants
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Clinvest Research LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Palm Research Center Sunset
    • Las Vegas, Nevada, United States, 89128
      • Palm Research Center Tenaya
  • New York
    • Buffalo, New York, United States, 14221
      • Research Foundation of SUNY - University of Buffalo
    • Mineola, New York, United States, 11501
      • NYU Langone Hospital - Long Island
    • New York, New York, United States, 10016
      • NYC Research
    • Syracuse, New York, United States, 13210
      • Suny Upstate Medical University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Diabetes & Endocrinology, P.A.
    • Dallas, Texas, United States, 75230
      • Dallas Diabetes Research Center
    • Dallas, Texas, United States, 75231
      • Research Institute Of Dallas
    • Dallas, Texas, United States, 75231
      • North Texas Endocrine Center
    • Houston, Texas, United States, 77043
      • Biopharma Informatic, LLC
    • Houston, Texas, United States, 77089
      • Amir A Hassan, MD, PA
    • Mesquite, Texas, United States, 75149
      • Southern Endocrinology Associates
    • Round Rock, Texas, United States, 78681
      • Texas Diabetes & Endocrinology, P.A.
  • 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 a clinical diagnosis of type 1 diabetes for at least 1 year prior to screening
• Have received treatment with basal-bolus insulin analog multiple daily injection therapy according to the local product label for at least 90 days prior to screening
• Have an HbA1c value of 7.0% to 10.0%, inclusive, as determined by the central laboratory at screening.
• Have a body mass index of ≤35 kilogram/square meter (kg/m²)

Exclusion Criteria:

• Have a diagnosis of type 2 diabetes, latent autoimmune diabetes, or specific types of diabetes other than type 1 diabetes
• Have a history of more than 1 episode of severe hypoglycemia, within the 6 months prior to screening.
• Have a history of more than 1 episode of diabetic ketoacidosis or hyperosmolar state or coma requiring hospitalization within the 6 months 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: Insulin Efsitora Alfa; Participants who were treated with prestudy basal insulin and prandial insulin therapy (100 units per milliliter (U/mL) Insulin Lispro) received 500 U/mL of insulin efsitora alfa administered once weekly (QW) for 52 weeks as subcutaneous injection, followed by a 5-week safety follow-up.	Drug: Insulin Efsitora Alfa; Administered SC; Other Names: LY3209590 and Basal Insulin-FC
Active Comparator: Insulin Degludec; Participants who were treated with prestudy basal insulin and prandial insulin therapy (100 U/mL Insulin Lispro) received 100 U/mL of Insulin Degludec administered once daily (QD) for 52 weeks as subcutaneous injection, followed by a 5-week safety follow-up.	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) at Week 26 [Noninferiority Analysis]	HbA1c is the glycosylated fraction of hemoglobin A. It is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined using Analysis of Covariance (ANCOVA) model with treatment + country + CGM use prior to study entry [yes/no]+ carbohydrate counting for prandial insulin[yes/no] + baseline value of the dependent variable (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach.	Baseline, Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 [Superiority Analysis]	HbA1c is the glycosylated fraction of hemoglobin A. It is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean was determined using ANCOVA model with treatment + country + CGM use prior to study entry [yes/no] + carbohydrate counting for prandial insulin[yes/no] + baseline value of the dependent variable (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] From Week 23 to Week 26	Percentage of time in glucose range between 70 and 180 milligram per deciliter (mg/dL) [3.9 and 10.0 millimole per liter (mmol/L)], measured by continued glucose monitoring (CGM) from week 23 to week 26 inclusive over a 24-Hour Period. The time component of the time-in-range statistic was calculated using the display time recorded by the CGM device. LS mean was determined using ANCOVA model with treatment + country + CGM use prior to study entry [yes/no] + carbohydrate counting for prandial insulin dosing [yes/no] + Hemoglobin A1c Stratum at Baseline and baseline value of the dependent variable (Type III sum of squares) as variables. Missing data at Week 23-26 were imputed by return-to-baseline multiple imputations approach	Week 23 to Week 26
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 = Baseline hypoglycemia rate + HbA1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.	Baseline up to Week 52
Change From Baseline in HbA1c at Week 52 [Noninferiority Analysis]	HbA1c is the glycosylated fraction of hemoglobin A. It is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean was determined using ANCOVA model with treatment + country + CGM use prior to study entry [yes/no]+ carbohydrate counting for prandial insulin[yes/no] + baseline value of the dependent variable (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 Fasting Blood Glucose	Change from baseline in fasting blood glucose measured by self-monitoring blood glucose (SMBG). LS mean was determined using ANCOVA model with treatment, country, CGM use prior to study entry [yes/no], carbohydrate counting for prandial insulin dosing [yes/no]) and baseline value of the dependent variable as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data were imputed by return-to-baseline multiple imputations approach.	Baseline, Week 26, and 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 23 to Week 26 and Week 49 to Week 52 was reported. LS mean was determined using mixed model repeated measures (MMRM) model with BASELINE + Country + Prior CGM use + Carbohydrate counting for Prandial Dose + Hemoglobin A1c Stratum at Baseline + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Unstructured variance-covariance structure was used.	Week 23 to Week 26 and Week 49 to Week 52
Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] From Week 49 to Week 52	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 49 to Week 52. LS mean was determined using ANCOVA model with treatment, country, CGM use prior to study entry [yes/no], carbohydrate counting for prandial insulin dosing [yes/no]) and Hemoglobin A1c Stratum at baseline and baseline value of the dependent variable as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data were imputed by return-to-baseline multiple imputations approach.	Week 49 to Week 52
Basal Insulin Dose	The insulin dose was recorded daily or weekly 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 BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Prior CGM use + Carbohydrate counting for Prandial Dose + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.	Week 26 and Week 52
Bolus Insulin Dose	The insulin dose was recorded daily or weekly in an electronic diary. The average daily bolus insulin dose at Week 26 and Week 52 was reported. LS mean was determined using MMRM model with BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Prior CGM use + Carbohydrate counting for Prandial Dose + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.	Week 26 and Week 52
Total Insulin Dose	The average weekly total insulin dose is the sum of the average weekly basal and bolus doses. LS mean was determined using MMRM model with BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Prior CGM use + Carbohydrate counting for Prandial Dose + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.	Week 26 and Week 52
Basal Insulin Dose to Total Insulin Dose Ratio	The basal/total insulin dose ratio is the average weekly basal dose divided by the average weekly total dose. LS mean was determined using MMRM model with BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Prior CGM use + Carbohydrate counting for Prandial Dose + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.	Week 26 and Week 52
Hypoglycemia Event Rate	Rate of Composite Level 2 and 3 Hypoglycemia Events were reported. Hypoglycemia with glucose <54 mg/dL (Level 2) or Severe Hypoglycemia confirmed by the investigator to be an event that required assistance for treatment (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 model using Number of episodes = Baseline hypoglycemia rate + 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 using Baseline + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.	Baseline, Week 26, and 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 23 to week 26 and week 49 to week 52 was reported. LS Mean was determined by ANCOVA model using treatment + country + CGM use prior to study entry [yes/no] + carbohydrate counting for prandial insulin dosing [yes/no] + Hemoglobin A1c Stratum at Baseline and baseline value of the dependent variable (Type III sum of squares). as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at week 23-26 and week 49-52 were imputed by return-to-baseline multiple imputations approach.	Week 23 to Week 26 and Week 49 to Week 52
Percentage of Time in Hyperglycemia Range With Blood Glucose >180 mg/dL (10.0 mmol/L) From Week 23 to Week 26	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 23 to Week 26 was reported. LS Mean was determined by ANCOVA model using treatment + country + CGM use prior to study entry [yes/no] + carbohydrate counting for prandial insulin dosing [yes/no] + Hemoglobin A1c Stratum at Baseline and baseline value of the dependent variable (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at week 23-week 26 were imputed by return-to-baseline multiple imputations approach.	Week 23 to Week 26
Percentage of Time in Hyperglycemia Range With Blood Glucose >180 mg/dL (10.0 mmol/L) From Week 49 to Week 52	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 49 to Week 52 was reported. LS Mean was determined by ANCOVA model using treatment + country + CGM use prior to study entry [yes/no] + carbohydrate counting for prandial insulin dosing [yes/no] + Hemoglobin A1c Stratum at Baseline and baseline value of the dependent variable (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at week 49-week 52 were imputed by return-to-baseline multiple imputations approach.	Week 49 to Week 52
Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) at Week 26	The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which measure Treatment Satisfaction, dealing with: 1. satisfaction with current treatment; 2. convenience of the treatment; 3. flexibility; 4. satisfaction with own understanding of participant's diabetes; 5. how likely to recommend their present treatment; and 6. how satisfied to continue with their present treatment. Each item is rated on a 7-point Likert scale (which ranges from -3 (much less satisfied) to +3 (much more satisfied). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied). 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 as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) at Week 52	The DTSQc score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which measure Treatment Satisfaction, dealing with: 1. satisfaction with current treatment; 2. convenience of the treatment; 3. flexibility; 4. satisfaction with own understanding of participant's diabetes; 5. how likely to recommend their present treatment; and 6. how satisfied to continue with their present treatment. Each item is rated on a 7-point Likert scale (which ranges from -3 (much less satisfied) to +3 (much more satisfied). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied). 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
Change From Baseline in Short Form-36 Version 2 (SF-36 v2) Acute Form (Physical-Component and Mental-Component) Scores	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. The 8 health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. 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. LS Mean was determined by MMRM model with Baseline + Country + Carbohydrate counting for Prandial Dose + Prior CGM use + Hemoglobin A1c Stratum at Baseline + Treatment + Time + Treatment*Time (Type III sum of squares). as variables. Unstructured variance-covariance structure was used.	Baseline, Week 26, and Week 52

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Chair: 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 1 Diabetes Treated With Multiple Daily Injection Therapy (QWINT-5)

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2022
• Primary Completion (Actual): May 7, 2024
• Study Completion (Actual): May 7, 2024

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 19, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Type 1 Diabetes (T1D)
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1; Physiological Effects of Drugs; Hypoglycemic Agents; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: 18263; I8H-MC-BDCY (Other Identifier: Eli Lilly and Company); 2021-005892-38 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual participant 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 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