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| ID | Type | Description | Link |
|---|---|---|---|
| I8H-MC-BDCW | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to determine the efficacy and safety of insulin efsitora alfa (LY3209590) administered weekly using a fixed dose escalation compared to insulin glargine in adults with type 2 diabetes (T2D) who are starting basal insulin therapy for the first time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Efsitora Alfa | Experimental | Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U. |
|
| Insulin Glargine | Active Comparator | Participants received insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Efsitora Alfa | Drug | Administered SC |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority Analysis] | HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over the last 2-3 months. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + GLP-1 RA Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputation approach. | Baseline, Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c [Superiority] | HbA1c is the glycated 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 + GLP-1 RA Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputation approach. |
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Inclusion Criteria:
Exceptions:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Research | Birmingham | Alabama | 35242 | United States | ||
| Syed Research Consultants Llc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41591636 | Derived | Miller E, Davidson MB, Bajaj HS, Rosenstock J, Philis-Tsimikis A, Bergenstal RM, Case M, Ilag L, Threlkeld R, Levasseur E, Gelsey F. Evaluation of Overall Health State, Treatment Burden, and Satisfaction with Insulin Efsitora Alfa (Efsitora) vs. Daily Comparator in Adults with Type 2 Diabetes in the QWINT Clinical Trial Program. Diabetes Ther. 2026 Mar;17(3):431-447. doi: 10.1007/s13300-025-01833-5. Epub 2026 Jan 27. | |
| 40548694 |
| Label | URL |
|---|---|
| A Study of LY3209590 Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1) | View source |
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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.
Data are available 6 months after the primary publication and approval of the indication studied in the United States (US) and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Efsitora Alfa | Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U. |
| FG001 | Insulin Glargine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 31, 2023 | Jul 14, 2025 |
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Sponsor will be blinded throughout the study.
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| Insulin Glargine | Drug | Administered SC |
|
| Baseline, Week 52 |
| Change From Baseline in Fasting Glucose | Change from baseline in fasting blood glucose measured by self-monitoring blood glucose (SMBG). LS mean was determined using ANCOVA model with Variable = Baseline + Country + GLP-1 RA Use at Baseline + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares). | Baseline, Week 52 |
| Basal Insulin Dose at Week 52 | The insulin dose was recorded daily or weekly in an electronic diary. The average weekly basal insulin dose at Week 52 was reported. LS mean was determined using MMRM model with Baseline + Hemoglobin A1c Stratum at Baseline + Country + GLP-1 RA use at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | Week 52 |
| Rate Per Year of Hypoglycemia Events | 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 = Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable. | Baseline up to Week 52 |
| Percentage of Participants With Hypoglycemia Events (Incidence) | Incidence of hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to the study drug. Incidence of Composite Level 2 and 3 Hypoglycemia Events was reported. Hypoglycemic episodes are defined as an event that is associated with reported signs and symptoms of 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). 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. | Week 52 |
| Rate Per Year of Nocturnal Hypoglycemia Events | 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 52. 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 52 |
| Percentage of Participants With Nocturnal Hypoglycemia Events (Incidence) | Incidence of nocturnal hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to the study drug. Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. 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 52.. | Week 52 |
| Change From Baseline in Body Weight | Change from baseline in body weight was reported. LS mean was determined using ANCOVA model with Variable = Baseline + Country + GLP-1 RA Use at Baseline + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares). | Baseline, Week 52 |
| Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D) Total Score | 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. The TRIM-D questionnaire consists of 5 sub-domains. Treatment Burden (6 items) Daily Life (5 items) Diabetes Management (5 items), Compliance (4 items), and Psychological Health (8 items), where each question is scored on a 1-5-point scale with a higher score indicating a better health state (less negative impact). Mean TRIM-D individual sub-domain scores and total scores are later transformed to a 0-100 scale for analysis. LS mean change in scores from baseline to 52 weeks for total score are presented here. LS mean was determined using MMRM model with BASELINE + Hemoglobin A1c Stratum at Baseline + Country + GLP-1 RA. Use at Randomization + Treatment + Time + Treatment*Time(Type III sum of squares) as variables. | Baseline, Week 52 |
| Change From Baseline in Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQ-c) | The DTSQ-c is a validated, patient-reported questionnaire designed to assess perceived changes in satisfaction with diabetes treatment over time. It is especially useful in clinical trials comparing a new treatment to a previous one. The DTSQ-c includes 8 items, each scored on a 7-point Likert scale ranging from -3 (Much less satisfied) to +3 (Much more satisfied). A score of 0 indicates no change in perception. This outcome reports three domains: (1) Perceived frequency of hypoglycaemia - lower scores reflect fewer perceived episodes; (2) Perceived frequency of hyperglycaemia - lower scores reflect fewer perceived episodes; (3) Treatment satisfaction -Aggregated score from the remaining 6 items assessing satisfaction with treatment, convenience, flexibility, understanding, and willingness to continue. A higher scores indicating greater improvement in satisfaction. Total score range: -18 to +18. | Baseline, Week 52 |
| Percentage of Participants Reporting Treatment Experience Using the Simplicity of Diabetes Treatment Questionnaire (SIM-Q) Single Medication Status Version | The SIM-Q is a brief 10-item measure developed to assess the simplicity and complexity of treatment for T2D. This version of the instrument assesses the simplicity and complexity of a single medication. Only the last 2 questions/items of the SIM-Q were completed by the study participants:
| Week 52 |
| Change From Baseline in Diabetes Injection Device Experience Questionnaire (DID-EQ) in Device Characteristics | DID-EQ is a validated, self-administered, 10-item PRO instrument designed to assess participants' perceptions of diabetes injection delivery systems.This outcome measure reports only the Device Characteristics Subscale, which includes Items 1 through 7. These items evaluate specific features of injection devices such as:
Each item is rated on a 4-point Likert scale: Strongly Disagree, Disagree, Agree, Strongly Agree. Responses are transformed to a 0-100 scale, where 0 represents most negative perception and 100 represents the most positive perception.Higher scores indicate more favorable perceptions of the injection device. LS Mean determined using ANCOVA model with Country + GLP-1 RA Use at Randomization + HbA1c Stratum at Baseline + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | Baseline, Week 52 |
| Percentage of Participants in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) (3-Global Items) | The DID-EQ is a validated, self-administered, 10-item PRO instrument designed to assess participants' perceptions of diabetes injection delivery systems. This outcome measure specifically reports the summary of DID-EQ scores for the 3 global items:
Each item is rated on a 4-point Likert scale:
Responses are transformed to a 0-100 scale, where:
Higher scores indicate more favorable perceptions of the injection device's global characteristics. | Week 52 |
| Sheffield |
| Alabama |
| 35660 |
| United States |
| AMCR Institute | Escondido | California | 92025 | United States |
| Velocity Clinical Research, Gardena | Gardena | California | 90247 | United States |
| National Research Institute - Huntington Park | Huntington Park | California | 90255 | United States |
| National Research Institute - Wilshire | Los Angeles | California | 90057 | United States |
| Diabetes Associates Medical Group | Orange | California | 92868 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| Millennium Clinical Trials | Thousand Oaks | California | 93065 | United States |
| University Clinical Investigators, Inc. | Tustin | California | 92780 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | United States |
| Clinical Research of West Florida, Inc. (Clearwater) | Clearwater | Florida | 33765 | United States |
| Suncoast Research Group | Miami | Florida | 33135 | United States |
| Clinical Research of West Florida | Tampa | Florida | 33606 | United States |
| Center for Advanced Research & Education | Gainesville | Georgia | 30501 | United States |
| Pacific Diabetes & Endocrine Center | Honolulu | Hawaii | 96813 | United States |
| Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative | Springfield | Illinois | 62711 | United States |
| American Health Network of Indiana, LLC - Franklin | Franklin | Indiana | 46131 | United States |
| American Health Network of Indiana, LLC - Muncie | Muncie | Indiana | 47304 | United States |
| Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa | 50265 | United States |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division | Troy | Michigan | 48098 | United States |
| Clinvest Research LLC | Springfield | Missouri | 65807 | United States |
| University Of Nebraska Medical Center | Omaha | Nebraska | 68198-4130 | United States |
| Mid Hudson Medical Research | New Windsor | New York | 12553 | United States |
| Meridian Clinical Research, LLC | Vestal | New York | 13850 | United States |
| Intend Research, LLC | Norman | Oklahoma | 73069 | United States |
| Decpa, Llc | Feasterville-Trevose | Pennsylvania | 19053 | United States |
| Office 18 | Pittsburgh | Pennsylvania | 15236 | United States |
| WR-Clinsearch, LLC | Chattanooga | Tennessee | 37421 | United States |
| Private Practice - Dr. Osvaldo A. Brusco | Corpus Christi | Texas | 78414 | United States |
| Dallas Diabetes Research Center | Dallas | Texas | 75230 | United States |
| Prime Revival Research Institute | Flower Mound | Texas | 75028 | United States |
| Endocrine Associates | Houston | Texas | 77004 | United States |
| Endocrine Ips, Pllc | Houston | Texas | 77079 | United States |
| North Hills Family Medicine/North Hills Medical Research | North Richland Hills | Texas | 76180 | United States |
| Texas Valley Clinical Research | Weslaco | Texas | 78596 | United States |
| Eastside Research Associates | Redmond | Washington | 98052 | United States |
| 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 |
| DIM Clínica Privada | Ramos Mejía | Buenos Aires | 1704 | Argentina |
| Go Centro Medico San Nicolás | San Nicolás de los Arroyos | Buenos Aires | 2900 | Argentina |
| Asociación de Beneficencia Hospital Sirio Libanés | Buenos Aires | Buenos Air | C1419AHN | Argentina |
| Stat Research S.A. | Buenos Aires | Ciudad Aut | C1023AAB | Argentina |
| Centro Médico Viamonte | Buenos Aires | Ciudad Aut | C1120AAC | Argentina |
| Glenny Corp | Buenos Aires | Ciudad Aut | C1430CKE | Argentina |
| CEMEDIAB | C.a.b.a. | Ciudad Aut | C1205AAO | Argentina |
| Investigaciones Medicas Imoba Srl | Buenos Aires | Ciudad Autónoma de Buenos Aire | C1056ABH | Argentina |
| CIPREC | Buenos Aires | Ciudad Autónoma de Buenos Aire | C1061AAS | Argentina |
| Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada | Ciudad Autonoma de Buenos Aire | Ciudad Autónoma de Buenos Aire | C1425AGC | Argentina |
| Centro Medico Privado San Vicente Diabetes | Córdoba | Córdoba Province | 5006 | Argentina |
| Instituto Médico Río Cuarto | Río Cuarto | Córdoba Province | 5800 | Argentina |
| CIPADI - Centro Integral de Prevencion y Atencion en Diabetes | Godoy Cruz | Mendoza Province | M5501ARP | Argentina |
| Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica | Rosario | Santa Fe Province | 2000 | Argentina |
| Clínica Mayo | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Fundación Respirar | Buenos Aires | C1426ABP | Argentina |
| CENUDIAB | Ciudad Autónoma de Buenos Aire | C1440AAD | Argentina |
| Centro de Diagnóstico y Rehabilitación (CEDIR) | Santa Fe | 3000 | Argentina |
| Sanatorio Norte | Santiago del Estero | 4200 | Argentina |
| Instituto Jalisciense de Investigacion en Diabetes y Obesidad | Guadalajara | Jalisco | 04460 | Mexico |
| Diseno y Planeacion en Investigacion Medica | Guadalajara | Jalisco | 44130 | Mexico |
| RM Pharma Specialists | Mexico City | Mexico City | 03100 | Mexico |
| Instituto de Diabetes, Obesidad y Nutricion | Cuernavaca | Morelos | 62250 | Mexico |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | Nuevo León | 64460 | Mexico |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | Nuevo León | 66460 | Mexico |
| Unidad Médica para la Salud Integral | San Nicolás de los Garza | Nuevo León | 66465 | Mexico |
| Medical Care and Research SA de CV | Mérida | Yucatán | 97070 | Mexico |
| Investigacion En Salud Y Metabolismo Sc | Chihuahua City | 31217 | Mexico |
| Ponce Medical School Foundation Inc. | Ponce | 00716 | Puerto Rico |
| Latin Clinical Trial Center | San Juan | 00909 | Puerto Rico |
| Derived |
| Rosenstock J, Bailey T, Connery L, Miller E, Desouza C, Wang Q, Leohr J, Knights A, Carr MC, Child CJ; QWINT-1 trial investigators. Weekly Fixed-Dose Insulin Efsitora in Type 2 Diabetes without Previous Insulin Therapy. N Engl J Med. 2025 Jul 24;393(4):325-335. doi: 10.1056/NEJMoa2502796. Epub 2025 Jun 22. |
Participants received insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments. |
| Received at Least One Dose of the Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
All randomized participants who received at least one dose of the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Efsitora | Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U. |
| BG001 | Glargine | Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| HemoglobinA1c (HbA1c) | HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over the last 2-3 months. | All randomized participants who received at least one dose of the study drug and had HbA1c measurement at baseline. | Mean | Standard Deviation | Percentage of HbA1c |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority Analysis] | HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over the last 2-3 months. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + GLP-1 RA Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputation approach. | All randomized participants who received at least one dose of the study drug and had HbA1c measurement at baseline or Week 52, excluding participants discontinuing the study treatment due to inadvertent enrollment. All measurements were included regardless of the use of study treatment or rescue medication. | Posted | Least Squares Mean | Standard Error | Percentage of HbA1c | Baseline, Week 52 |
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| Secondary | Change From Baseline in HbA1c [Superiority] | HbA1c is the glycated 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 + GLP-1 RA Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputation approach. | All randomized participants who received at least one dose of the study drug and had HbA1c measurement at baseline or Week 52, excluding participants discontinuing the study treatment due to inadvertent enrollment. All measurements were included regardless of the use of study treatment or rescue medication. | Posted | Least Squares Mean | Standard Error | Percentage of HbA1c | Baseline, Week 52 |
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| Secondary | Change From Baseline in Fasting Glucose | Change from baseline in fasting blood glucose measured by self-monitoring blood glucose (SMBG). LS mean was determined using ANCOVA model with Variable = Baseline + Country + GLP-1 RA Use at Baseline + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares). | All randomized participants who received at least one dose of the study drug and had a baseline and at least one post-baseline value for this outcome. Participants who discontinued the study drug due to inadvertent enrollment were excluded. | Posted | Least Squares Mean | Standard Error | milligrams per deciliter (mg/dL) | Baseline, Week 52 |
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| Secondary | Basal Insulin Dose at Week 52 | The insulin dose was recorded daily or weekly in an electronic diary. The average weekly basal insulin dose at Week 52 was reported. LS mean was determined using MMRM model with Baseline + Hemoglobin A1c Stratum at Baseline + Country + GLP-1 RA use at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome. | Posted | Least Squares Mean | Standard Error | Units per week (U/week) | Week 52 |
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| Secondary | Rate Per Year of Hypoglycemia Events | 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 = Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable. | All randomized participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | Events per year | Baseline up to Week 52 |
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| Secondary | Percentage of Participants With Hypoglycemia Events (Incidence) | Incidence of hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to the study drug. Incidence of Composite Level 2 and 3 Hypoglycemia Events was reported. Hypoglycemic episodes are defined as an event that is associated with reported signs and symptoms of 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). 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. | All randomized participants who received at least one dose of the study drug. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Rate Per Year of Nocturnal Hypoglycemia Events | 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 52. 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. | All randomized participants who received at least one dose of the study drug. | Posted | Mean | Standard Error | Events per year | Baseline up to Week 52 |
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| Secondary | Percentage of Participants With Nocturnal Hypoglycemia Events (Incidence) | Incidence of nocturnal hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to the study drug. Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. 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 52.. | All randomized participants who received at least one dose of the study drug. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Change From Baseline in Body Weight | Change from baseline in body weight was reported. LS mean was determined using ANCOVA model with Variable = Baseline + Country + GLP-1 RA Use at Baseline + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares). | All randomized participants who received at least one dose of the study drug and had a baseline and at least one post-baseline value for this outcome. Participants who discontinued the study drug due to inadvertent enrollment were excluded. | Posted | Least Squares Mean | Standard Error | Kilogram (kg) | Baseline, Week 52 |
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| Secondary | Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D) Total Score | 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. The TRIM-D questionnaire consists of 5 sub-domains. Treatment Burden (6 items) Daily Life (5 items) Diabetes Management (5 items), Compliance (4 items), and Psychological Health (8 items), where each question is scored on a 1-5-point scale with a higher score indicating a better health state (less negative impact). Mean TRIM-D individual sub-domain scores and total scores are later transformed to a 0-100 scale for analysis. LS mean change in scores from baseline to 52 weeks for total score are presented here. LS mean was determined using MMRM model with BASELINE + Hemoglobin A1c Stratum at Baseline + Country + GLP-1 RA. Use at Randomization + Treatment + Time + Treatment*Time(Type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug and had a baseline and at least one post-baseline value for this outcome. Participants who discontinued the study drug due to inadvertent enrollment were excluded. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, Week 52 |
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| Secondary | Change From Baseline in Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQ-c) | The DTSQ-c is a validated, patient-reported questionnaire designed to assess perceived changes in satisfaction with diabetes treatment over time. It is especially useful in clinical trials comparing a new treatment to a previous one. The DTSQ-c includes 8 items, each scored on a 7-point Likert scale ranging from -3 (Much less satisfied) to +3 (Much more satisfied). A score of 0 indicates no change in perception. This outcome reports three domains: (1) Perceived frequency of hypoglycaemia - lower scores reflect fewer perceived episodes; (2) Perceived frequency of hyperglycaemia - lower scores reflect fewer perceived episodes; (3) Treatment satisfaction -Aggregated score from the remaining 6 items assessing satisfaction with treatment, convenience, flexibility, understanding, and willingness to continue. A higher scores indicating greater improvement in satisfaction. Total score range: -18 to +18. | All randomized participants who received at least one dose of the study drug and had a baseline and at least one post-baseline value for this outcome. Participants who discontinued the study drug due to inadvertent enrollment were excluded. | Posted | Mean | Standard Error | Score on a scale | Baseline, Week 52 |
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| Secondary | Percentage of Participants Reporting Treatment Experience Using the Simplicity of Diabetes Treatment Questionnaire (SIM-Q) Single Medication Status Version | The SIM-Q is a brief 10-item measure developed to assess the simplicity and complexity of treatment for T2D. This version of the instrument assesses the simplicity and complexity of a single medication. Only the last 2 questions/items of the SIM-Q were completed by the study participants:
| All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome. Participants who discontinued the study drug due to inadvertent enrollment were excluded. | Posted | Number | Percentage of participants | Week 52 |
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| Secondary | Change From Baseline in Diabetes Injection Device Experience Questionnaire (DID-EQ) in Device Characteristics | DID-EQ is a validated, self-administered, 10-item PRO instrument designed to assess participants' perceptions of diabetes injection delivery systems.This outcome measure reports only the Device Characteristics Subscale, which includes Items 1 through 7. These items evaluate specific features of injection devices such as:
Each item is rated on a 4-point Likert scale: Strongly Disagree, Disagree, Agree, Strongly Agree. Responses are transformed to a 0-100 scale, where 0 represents most negative perception and 100 represents the most positive perception.Higher scores indicate more favorable perceptions of the injection device. LS Mean determined using ANCOVA model with Country + GLP-1 RA Use at Randomization + HbA1c Stratum at Baseline + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All randomized participants who received at least one dose of the study drug and had a baseline and at least one post-baseline value for this outcome. Participants who discontinued the study drug due to inadvertent enrollment were excluded. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 52 |
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| Secondary | Percentage of Participants in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) (3-Global Items) | The DID-EQ is a validated, self-administered, 10-item PRO instrument designed to assess participants' perceptions of diabetes injection delivery systems. This outcome measure specifically reports the summary of DID-EQ scores for the 3 global items:
Each item is rated on a 4-point Likert scale:
Responses are transformed to a 0-100 scale, where:
Higher scores indicate more favorable perceptions of the injection device's global characteristics. | All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome. Participants who discontinued the study drug due to inadvertent enrollment were excluded. | Posted | Number | percentage of participants | Week 52 |
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Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Efsitora | Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U. | 3 | 397 | 26 | 397 | 104 | 397 |
| EG001 | Glargine | Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments. | 3 | 398 | 21 | 398 | 121 | 398 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Aortic valve stenosis | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Abdominal hernia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Dermatofibrosarcoma protuberans | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
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| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
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| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
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| Cerebellar haemorrhage | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
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| Chronic kidney disease | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
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| Abnormal uterine bleeding | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
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| Adnexa uteri mass | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
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| Breast hyperplasia | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Prostatectomy | Surgical and medical procedures | MedDRA 27.0 | Systematic Assessment |
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| Peripheral vascular disorder | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Drug titration error | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 08004595979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 26, 2024 | Jul 14, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments. |
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Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments. |
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Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.
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| OG001 | Glargine | Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments. |
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