Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I8H-MC-BDCU | Other Identifier | Eli Lilly and Company | |
| 2021-002569-16 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The reason for this study is to see if the study drug insulin efsitora alfa (LY3209590) is safe and effective in participants with Type 2 diabetes that have already been treated with basal insulin. The study consists of a 3-week screening/lead-in period, a 78-week treatment period and a 5-week safety follow-up period. The study will last up to 86 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 500 U/mL - Insulin Efsitora | Experimental | Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW). |
|
| 100 U/mL - Insulin Degludec | Active Comparator | Participants received 100 U/mL insulin degludec administered SC once daily (QD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Efsitora Alfa | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority] | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputation approach. | Baseline, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) [Superiority] | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputation approach. |
Not provided
Inclusion Criteria:
Have been diagnosed with Type 2 diabetes according to the World Health Organization (WHO) criteria treated with basal insulin
Are receiving ≥10 units of basal insulin per day and ≤110 units per day at screening
Have HbA1c value of 6.5% - 10% inclusive, at screening
Have a Body mass index (BMI) less than or equal to 45 kilogram/square meter (kg/m²)
Have been treated with one of the following stable insulin regimens at least 90 days prior to screening:
acceptable non insulin glucose lowering therapies may include 0 to up to 3 of the following:
Exclusion Criteria:
Have Type 1 diabetes mellitus
Have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease, except Nonalcoholic Fatty Liver Disease (NAFLD)
Estimated glomerular filtration rate (eGFR) <20 milliliters/minute/1.73 square meter (m²)
Have active or untreated malignancy
Are pregnant
Have a significant weight gain or loss the past 3 months
Have received anytime in the past 6 months, any of the following insulin therapies:
Have had any of New York Heart Association Class IV heart failure or any of the following CV conditions in the past 3 months:
Gastrointestinal: have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery (Lap-Band) or sleeve gastrectomy within 1 year prior to screening
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|---|---|---|
| Medical Investigations | Little Rock | Arkansas | 72211 | United States | ||
| John Muir Physician Network Research Center |
| 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. | |
| 40562047 |
| Label | URL |
|---|---|
| A Study of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin | View source |
Not provided
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 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.
Not provided
Participants underwent a 3 week screening and lead-in period, and a 78-week treatment period, followed by a 5-week safety follow-up period.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 500 U/mL - Insulin Efsitora | Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW). |
| FG001 | 100 U/mL - Insulin Degludec |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 13, 2022 | Apr 29, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Insulin Degludec | Drug | Administered SC |
|
| Baseline, Week 26 |
| Nocturnal Hypoglycemia Event Rate | The event rate of participant-reported clinically significant glucose <54 mg/dL (3.0 mmol/L) or severe nocturnal hypoglycemia that occurs at night and presumably during sleep between midnight and 6:00 AM), measured during treatment period up to week 78. Group mean is reported here. Group mean is determined by Negative Binomial Model using Number of episodes = Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable. | Baseline up to Week 78 |
| Percentage of Time in Glucose Range Between 70 and 180 mg/dL (3.9 and 10.0 mmol/L) | Percentage of time in glucose range between 70 and 180 mg/dL (3.9 and 10.0 millimoles per liter (mmol/L)) inclusive measured by continued glucose monitoring (CGM) during CGM session prior to week 26. LS Mean was calculated using ANCOVA model with Baseline + Country + Hemoglobin A1c Stratum at Baseline + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data during CGM session prior to Week 26 were imputed by return-to-baseline multiple imputation approach. | Week 22 to Week 26 |
| Change From Baseline in Fasting Glucose | Fasting glucose measured by Self-Monitoring of Blood Glucose (SMBG). LS Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment (Type III sum of squares) as variables. Missing data at baseline are imputed with multiple imputation under assumption of missing at random. Missing data at Week 26 are imputed by return-to-baseline multiple imputation approach. | Baseline, Week 26 |
| Weekly Insulin Dose at Week 26 | The average weekly insulin dose at Week 26 was reported. LS Mean was determined by mixed model repeated measures (MMRM) model using BASELINE + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry. | Week 26 |
| Hypoglycemia Event Rate | Patient reported events of hypoglycemia - Hypoglycemia with glucose <54 mg/dL (Level 2) or Severe Hypoglycemia (Level 3) was reported. A severe hypoglycemic event is characterized by altered mental or physical status requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions for the treatment of hypoglycemia. Group mean was reported and determined by Negative binomial method using Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as variables. | Baseline up to Week 78 |
| Change From Baseline in Body Weight | Change from baseline in body weight was reported. LS Mean was determined by MMRM model using BASELINE + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | Baseline, Week 78 |
| Percentage of Time in Hypoglycemia Range | Percentage of time in hypoglycemia range with glucose <54 mg/dL (3.0 mmol/L) measured during CGM from 22-26 weeks. LS Mean was determined using ANCOVA model using Baseline + Country + Hemoglobin A1c Stratum at Baseline + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at baseline were imputed with multiple imputation under assumption of missing at random. Missing data at Week 22-26 were imputed by return-to-baseline multiple imputation approach. | Week 22 to Week 26 |
| Percentage of Time in Hyperglycemia Range | Percentage of time in hyperglycemia range with glucose >180 mg/dL (10.0 mmol/L) measured during the CGM session from 22-26 weeks. LS Mean was determined using ANCOVA model using Baseline + Country + Hemoglobin A1c Stratum at Baseline + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at baseline were imputed with multiple imputation under assumption of missing at random. Missing data at Week 22-26 were imputed by return-to-baseline multiple imputation approach. | Week 22 to Week 26 |
| Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D) | The TRIM-D is a self-administered instrument, which assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatments. The TRIM-D consists of 28 items each assessed on a 5-point scale. TRIM-D items assess 5 domains of impact:
Items within each domain are summed to obtain a raw domain score, which is then transformed to a 0-100 scale, where higher scores indicate a greater impact on participant's functioning and well-being. LS mean was determined using MMRM model with BASELINE + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | Baseline, Week 26, Week 52, Week 78 |
| Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 26 | DTSQc treatment satisfaction score is a 6-item questionnaire which assesses relative change in overall treatment satisfaction. The treatment satisfaction score ranges from -18 to 18, where higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. | Week 26 |
| Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 52 | DTSQc treatment satisfaction score is a 6-item questionnaire which assesses relative change in overall treatment satisfaction. The treatment satisfaction score ranges from -18 to 18, where higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. | Week 52 |
| Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 78 | DTSQc treatment satisfaction score is a 6-item questionnaire which assesses relative change in overall treatment satisfaction. The treatment satisfaction score ranges from -18 to 18, where higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. | Week 78 |
| Concord |
| California |
| 94520 |
| United States |
| AMCR Institute | Escondido | California | 92025 | United States |
| National Research Institute - Huntington Park | Huntington Park | California | 90255 | United States |
| Scripps Whittier Diabetes Institute | La Jolla | California | 92037 | United States |
| Diabetes Associates Medical Group | Orange | California | 92868 | United States |
| University Clinical Investigators, Inc. | Tustin | California | 92780 | United States |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | United States |
| Encore Medical Research | Hollywood | Florida | 33021 | United States |
| New Horizon Research Center | Miami | Florida | 33165 | United States |
| Suncoast Clinical Research, Inc. | New Port Richey | Florida | 34652 | United States |
| West Orange Endocrinology | Ocoee | Florida | 34761 | United States |
| Balanced Life Health Care Solutions/SKYCRNG | Lawrenceville | Georgia | 30046 | United States |
| Rocky Mountain Clinical Research | Idaho Falls | Idaho | 83404 | United States |
| Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa | 50265 | United States |
| L-MARC Research Center | Louisville | Kentucky | 40213 | United States |
| Endocrine and Metabolic Consultants | Rockville | Maryland | 20852 | United States |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division | Troy | Michigan | 48098 | United States |
| HealthPartners Institute dba International Diabetes Center | Minneapolis | Minnesota | 55416 | United States |
| SKY Clinical Research Network Group - Hall | Fayette | Mississippi | 39069 | United States |
| Clinvest Research LLC | Springfield | Missouri | 65807 | United States |
| Palm Research Center Tenaya | Las Vegas | Nevada | 89128 | United States |
| Albany Medical College, Division of Community Endocrinology | Albany | New York | 12203 | United States |
| NYC Research | New York | New York | 10016 | United States |
| Lillestol Research | Fargo | North Dakota | 58104 | United States |
| Aventiv Research Inc | Columbus | Ohio | 43213 | United States |
| Intend Research, LLC | Norman | Oklahoma | 73069 | United States |
| Heritage Valley Medical Group, Inc. | Beaver | Pennsylvania | 15009 | United States |
| Jefferson Clinical Research Institute (JCRI) | Philadelphia | Pennsylvania | 19114 | United States |
| Preferred Primary Care Physicians | Uniontown | Pennsylvania | 15401 | United States |
| Gadolin Research | Beaumont | Texas | 77702 | United States |
| Dallas Diabetes Research Center | Dallas | Texas | 75230 | United States |
| Juno Research | Houston | Texas | 77040 | United States |
| Biopharma Informatic, LLC | Houston | Texas | 77043 | United States |
| Southern Endocrinology Associates | Mesquite | Texas | 75149 | United States |
| Texas Diabetes & Endocrinology, P.A. | Round Rock | Texas | 78681 | United States |
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | United States |
| Rainier Clinical Research Center | Renton | Washington | 98057 | 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 |
| Go Centro Medico San Nicolás | San Nicolás de los Arroyos | Buenos Aires | 2900 | Argentina |
| Consultorio de Investigación Clínica EMO SRL | Ciudad Autonoma de Buenos Aire | Buenos Air | C1405BUB | Argentina |
| Stat Research S.A. | Ciudad Autónoma de Buenos Aire | Buenos Air | C1023AAB | Argentina |
| Centro Médico Viamonte | Buenos Aires | Ciudad Aut | C1120AAC | Argentina |
| Mautalen Salud e Investigación | Buenos Aires | Ciudad Aut | C1128AAF | Argentina |
| Instituto Centenario | CABA | Ciudad Autónoma de Buenos Aire | 1204 | Argentina |
| Centro Medico Privado CEMAIC | Capital | Córdoba Province | X5008HHW | Argentina |
| CIPADI - Centro Integral de Prevencion y Atencion en Diabetes | Godoy Cruz | Mendoza Province | M5501ARP | Argentina |
| Instituto Médico Catamarca IMEC | Rosario | Santa Fe Province | 2000 | Argentina |
| CEMEDIC | Buenos Aires | 1407 | Argentina |
| CENUDIAB | Ciudad Autónoma de Buenos Aire | C1440AAD | Argentina |
| Centro Diabetológico Dr. Waitman | Córdoba | 5000 | Argentina |
| DRC Gyógyszervizsgáló Központ | Balatonfüred | Veszprém megye | 8230 | Hungary |
| Kanizsai Dorottya Korhaz | Nagykanizsa | Zala County | 8800 | Hungary |
| Zala Megyei Szent Rafael Kórház | Zalaegerszeg | Zala County | 8900 | Hungary |
| Szent Margit Rendelointézet | Budapest | 1032 | Hungary |
| Szent János Kórház | Budapest | 1125 | Hungary |
| Strazsahegy Medicina Bt. | Budapest | H1171 | Hungary |
| Tokuyama Clinic | Mihama-ku,Chiba City | Chiba | 261-0004 | Japan |
| Yuri Ono Clinic | Sapporo | Hokkaido | 060-0001 | Japan |
| Nakamoto Internal Medicine Clinic | Mito | Ibaraki | 310-0826 | Japan |
| Kozawa Eye Hospital and Diabetes Center | Mito | Ibaraki | 310-0845 | Japan |
| Noritake Clinic | Ushiku | Ibaraki | 300-1207 | Japan |
| Matoba Internal Medicine Clinic | Ebina | Kanagawa | 243-0432 | Japan |
| Takai Internal Medicine Clinic | Kamakura-shi | Kanagawa | 247-0056 | Japan |
| Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic | Yamato-shi | Kanagawa | 242-0004 | Japan |
| Shiraiwa Medical Clinic | Kashihara | Osaka | 582-0005 | Japan |
| Takatsuki Red Cross Hospital | Takatsuki | Osaka | 569-1045 | Japan |
| Shimizu Clinic Fusa | Saitama-shi | Saitama | 336-0967 | Japan |
| Oyama East Clinic | Oyama | Tochigi | 323-0022 | Japan |
| Tokyo-Eki Center-building Clinic | Chuo Ku | Tokyo | 103-0027 | Japan |
| The Institute of Medical Science, Asahi Life Foundation | Chuo-ku | Tokyo | 103-0002 | Japan |
| Medical Corporation Chiseikai Tokyo Center Clinic | Chuo-ku | Tokyo | 103-0028 | Japan |
| Fukuwa Clinic | Chuo-ku | Tokyo | 104-0031 | Japan |
| Jinnouchi Hospital | Kumamoto | 862-0976 | Japan |
| Heiwadai Hospital | Miyazaki | 880-0034 | Japan |
| AMC Nishiumeda Clinic | Osaka | 530-0001 | Japan |
| Abe Clinic | Ōita | 870-0039 | Japan |
| OMEDICA Medical Center | Poznan | Greater Poland Voivodeship | 60-111 | Poland |
| Gaja Poradnie Lekarskie Maciej Wiza | Poznan | Greater Poland Voivodeship | 61-251 | Poland |
| NZOZ Diab-Endo-Met | Krakow | Lesser Poland Voivodeship | 31-261 | Poland |
| Private Practice - Dr. Robert Witek | Tarnów | Lesser Poland Voivodeship | 33-100 | Poland |
| CenterMed Lublin NZOZ | Lublin | Lublin Voivodeship | 20-044 | Poland |
| Gabinety TERPA | Lublin | Lublin Voivodeship | 20-333 | Poland |
| NZOZ Medica | Lublin | Lublin Voivodeship | 20-538 | Poland |
| Centrum Badan Klinicznych PI-House sp. z o.o. | Gdansk | Pomeranian Voivodeship | 80-546 | Poland |
| NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki | Ruda Śląska | Silesian Voivodeship | 41-709 | Poland |
| Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna | Lodz | Łódź Voivodeship | 90338 | Poland |
| IRMED | Piotrkow Trybunalski | Łódź Voivodeship | 97-300 | Poland |
| GCM Medical Group, PSC - Hato Rey Site | San Juan | PR | 00917 | Puerto Rico |
| Mgcendo Llc | San Juan | 00921 | Puerto Rico |
| MediVet s.r.o. | Malacky | Bratislava Region | 901 01 | Slovakia |
| Human Care s.r.o. | Košice | Košice Region | 04012 | Slovakia |
| Areteus s.r.o. | Trebišov | Košice Region | 075 01 | Slovakia |
| MEDI-DIA s.r.o. | Sabinov | Presov | 083 01 | Slovakia |
| Diacrin .s.ro. | Bratislava | 84102 | Slovakia |
| DIA-MED CENTRUM s.r.o. | Púchov | 020 01 | Slovakia |
| ENDIAMED s.r.o | Dolný Kubín | Žilina Region | 026 01 | Slovakia |
| Kangwon National University Hospital | Chuncheon | Kang-won-do | 24289 | South Korea |
| Yonsei University-Wonju Severance Christian Hospital | Wŏnju | Kang-won-do | 26426 | South Korea |
| Korea University Ansan Hospital | Ansan-si | Kyǒnggi-do | 15355 | South Korea |
| Hanyang University Guri Hospital | Guri-si | Kyǒnggi-do | 11923 | South Korea |
| Yeungnam Univeristy Medical Center | Gyeongsan-si | Kyǒngsangbuk-do | 42415 | South Korea |
| Inje University Sanggye Paik Hospital | Seoul | Seoul-teukbyeolsi [Seoul] | 01757 | South Korea |
| Seoul National University Hospital | Seoul | Seoul-teukbyeolsi [Seoul] | 03080 | South Korea |
| Asan Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] | 05505 | South Korea |
| Hallym University Kangnam Sacred Heart Hospital | Seoul | Seoul-teukbyeolsi [Seoul] | 07441 | South Korea |
| Kyung Hee University Hospital at Gangdong | Seoul | Seoul-teukbyeolsi [Seoul] | 134-090 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | Seoul-teuk | 03722 | South Korea |
| Ulsan University Hospital | Ulsan | Ulsan-Kwangyǒkshi | 44033 | South Korea |
| CHUAC-Complejo Hospitalario Universitario A Coruña | A Coruña | A Coruña [La Coruña] | 15006 | Spain |
| Centro Periférico de Especialidades Bola Azul | Almería | Almería | 04009 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | Andalusia | 29010 | Spain |
| Hospital Quiron Infanta Luisa | Seville | Andalusia | 41010 | Spain |
| Clínica Juaneda | Palma de Mallorca | Balears [Baleares] | 07014 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Vithas Hospital Sevilla | Seville | Sevilla | 41950 | Spain |
| Hospital Universitario de La Ribera | Alzira | Valenciana, Comunitat | 46600 | Spain |
| Hospital General Universitario de Valencia | Valencia | Valenciana, Comunitat | 46014 | Spain |
| Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE) | Seville | 41003 | Spain |
| Chung Shan Medical University Hospital | Taichung | Taichung | 402 | Taiwan |
| Taichung Veterans General Hospital | Taichung | Taichung | 407 | Taiwan |
| Chi Mei Medical Center | Tainan | Tainan | 71004 | Taiwan |
| Fu Jen Catholic University Hospital | New Taipei City | 24352 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Derived |
| Philis-Tsimikas A, Bergenstal RM, Bailey TS, Jinnouchi H, Thrasher JR, Ilag L, Mitra J, Syring K, Threlkeld RJ. Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 2 diabetes currently treated with basal insulin (QWINT-3): a phase 3, randomised, non-inferiority trial. Lancet. 2025 Jun 28;405(10497):2279-2289. doi: 10.1016/S0140-6736(25)01044-X. Epub 2025 Jun 22. |
Participants received 100 U/mL insulin degludec administered SC once daily (QD).
| Received At Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-Up Period |
|
|
All participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 500 U/mL - Insulin Efsitora | Participants received 500 U/mL insulin efsitora administered SC QW. |
| BG001 | 100 U/mL - Insulin Degludec | Participants received 100 U/mL insulin degludec administered SC QD. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||
| HemoglobinA1c (HbA1c) | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. | Mean | Standard Deviation | Percentage of HbA1c |
|
| 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] | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputation approach. | All participants who received at least one dose of study drug and had evaluable data for this outcome at baseline or week 26. Participants who were assigned treatment by mistake were excluded. | Posted | Least Squares Mean | Standard Error | Percentage of HbA1c | Baseline, Week 26 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Hemoglobin A1c (HbA1c) [Superiority] | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputation approach. | All participants who received at least one dose of study drug and had evaluable data for this outcome at baseline or week 26. Participants who were assigned treatment by mistake were excluded. | Posted | Least Squares Mean | Standard Error | Percentage of HbA1c | Baseline, Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Nocturnal Hypoglycemia Event Rate | The event rate of participant-reported clinically significant glucose <54 mg/dL (3.0 mmol/L) or severe nocturnal hypoglycemia that occurs at night and presumably during sleep between midnight and 6:00 AM), measured during treatment period up to week 78. Group mean is reported here. Group mean is determined by Negative Binomial Model using Number of episodes = Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable. | All participants who received at least one dose of study drug. | Posted | Mean | Standard Error | Events per year | Baseline up to Week 78 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Time in Glucose Range Between 70 and 180 mg/dL (3.9 and 10.0 mmol/L) | Percentage of time in glucose range between 70 and 180 mg/dL (3.9 and 10.0 millimoles per liter (mmol/L)) inclusive measured by continued glucose monitoring (CGM) during CGM session prior to week 26. LS Mean was calculated using ANCOVA model with Baseline + Country + Hemoglobin A1c Stratum at Baseline + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data during CGM session prior to Week 26 were imputed by return-to-baseline multiple imputation approach. | All randomized participants who took at least one dose of the study drug and had evaluable data for this outcome at baseline or Week 22-26 were included. Participants who were assigned treatment by mistake were excluded. | Posted | Least Squares Mean | Standard Error | Percentage of time | Week 22 to Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Glucose | Fasting glucose measured by Self-Monitoring of Blood Glucose (SMBG). LS Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment (Type III sum of squares) as variables. Missing data at baseline are imputed with multiple imputation under assumption of missing at random. Missing data at Week 26 are imputed by return-to-baseline multiple imputation approach. | All randomized participants who took at least one dose of the study drug and had evaluable data for this outcome at baseline or Week 26 were included. Participants who were assigned treatment by mistake were excluded. | Posted | Least Squares Mean | Standard Error | milligrams per deciliter (mg/dL) | Baseline, Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Weekly Insulin Dose at Week 26 | The average weekly insulin dose at Week 26 was reported. LS Mean was determined by mixed model repeated measures (MMRM) model using BASELINE + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry. | All participants who received at least one dose of study drug, had a baseline and at least one post-baseline value for this outcome. Participants who were assigned treatment by mistake were excluded. | Posted | Least Squares Mean | Standard Error | Units per week of insulin | Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hypoglycemia Event Rate | Patient reported events of hypoglycemia - Hypoglycemia with glucose <54 mg/dL (Level 2) or Severe Hypoglycemia (Level 3) was reported. A severe hypoglycemic event is characterized by altered mental or physical status requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions for the treatment of hypoglycemia. Group mean was reported and determined by Negative binomial method using Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as variables. | All participants who received at least one dose of study drug. | Posted | Mean | Standard Error | Events per year | Baseline up to Week 78 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All participants who received at least one dose of study drug, had a baseline and at least one post-baseline value for this outcome. Participants who were assigned treatment by mistake were excluded. | Posted | Least Squares Mean | Standard Error | kilograms (kg) | Baseline, Week 78 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Time in Hypoglycemia Range | Percentage of time in hypoglycemia range with glucose <54 mg/dL (3.0 mmol/L) measured during CGM from 22-26 weeks. LS Mean was determined using ANCOVA model using Baseline + Country + Hemoglobin A1c Stratum at Baseline + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at baseline were imputed with multiple imputation under assumption of missing at random. Missing data at Week 22-26 were imputed by return-to-baseline multiple imputation approach. | All randomized participants who took at least one dose of the study drug and had evaluable data for this outcome at baseline or Week 22-26 were included. Participants who were assigned treatment by mistake were excluded. | Posted | Least Squares Mean | Standard Error | Percentage of time | Week 22 to Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Time in Hyperglycemia Range | Percentage of time in hyperglycemia range with glucose >180 mg/dL (10.0 mmol/L) measured during the CGM session from 22-26 weeks. LS Mean was determined using ANCOVA model using Baseline + Country + Hemoglobin A1c Stratum at Baseline + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at baseline were imputed with multiple imputation under assumption of missing at random. Missing data at Week 22-26 were imputed by return-to-baseline multiple imputation approach. | All randomized participants who took at least one dose of the study drug and had evaluable data for this outcome at baseline or Week 22-26 were included. Participants who were assigned treatment by mistake were excluded. | Posted | Least Squares Mean | Standard Error | Percentage of time | Week 22 to Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D) | The TRIM-D is a self-administered instrument, which assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatments. The TRIM-D consists of 28 items each assessed on a 5-point scale. TRIM-D items assess 5 domains of impact:
Items within each domain are summed to obtain a raw domain score, which is then transformed to a 0-100 scale, where higher scores indicate a greater impact on participant's functioning and well-being. LS mean was determined using MMRM model with BASELINE + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All participants who received at least one dose of the study drug, had a baseline and at least one post-baseline value for this outcome. Participants who were assigned treatment by mistake were excluded. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, Week 26, Week 52, Week 78 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 26 | DTSQc treatment satisfaction score is a 6-item questionnaire which assesses relative change in overall treatment satisfaction. The treatment satisfaction score ranges from -18 to 18, where higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. | All participants who received at least one dose of study drug and had evaluable data for this outcome. Participants who were assigned treatment by mistake were excluded. | Posted | Mean | Standard Deviation | Score on a scale | Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 52 | DTSQc treatment satisfaction score is a 6-item questionnaire which assesses relative change in overall treatment satisfaction. The treatment satisfaction score ranges from -18 to 18, where higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. | All participants who received at least one dose of study drug and had evaluable data for this outcome. Participants who were assigned treatment by mistake were excluded. | Posted | Mean | Standard Deviation | Score on a scale | Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 78 | DTSQc treatment satisfaction score is a 6-item questionnaire which assesses relative change in overall treatment satisfaction. The treatment satisfaction score ranges from -18 to 18, where higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. | All participants who received at least one dose of study drug and had evaluable data for this outcome. Participants who were assigned treatment by mistake were excluded. | Posted | Mean | Standard Deviation | Score on a scale | Week 78 |
|
|
Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. 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 | 500 U/mL - Insulin Efsitora | Participants received 500 U/mL insulin efsitora administered SC QW. | 7 | 655 | 103 | 655 | 241 | 655 |
| EG001 | 100 U/mL - Insulin Degludec | Participants received 100 U/mL insulin degludec administered SC QD. | 2 | 331 | 37 | 331 | 102 | 331 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute left ventricular failure | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac valve disease | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chronic coronary syndrome | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Microvascular coronary artery disease | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Phimosis | Congenital, familial and genetic disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Primary hyperthyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal adhesions | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Alcoholic pancreatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Inguinal hernia, obstructive | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vascular stent stenosis | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute cholecystitis necrotic | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Covid-19 pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Hcov-oc43 infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Hiv infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Infective exacerbation of asthma | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Craniofacial fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Incorrect dose administered | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Limb crushing injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Continuous glucose monitoring | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Angiomyolipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Carcinoid tumour pulmonary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Chromophobe renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Colorectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Ductal adenocarcinoma of pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Metastatic gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Salivary gland cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dural arteriovenous fistula | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoglycaemic unconsciousness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myelopathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Spondylitic myelopathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thalamus haemorrhage | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bladder neck obstruction | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vocal cord polyp | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Coronary revascularisation | Surgical and medical procedures | MedDRA 27.0 | Systematic Assessment |
| |
| Limb amputation | Surgical and medical procedures | MedDRA 27.0 | Systematic Assessment |
| |
| Skin graft | Surgical and medical procedures | MedDRA 27.0 | Systematic Assessment |
| |
| Aneurysm thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arterial disorder | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Dose calculation error | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 27, 2024 | Apr 29, 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 |
|---|---|
| C571886 | insulin degludec |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Hungary |
|
| Japan |
|
| Poland |
|
| Slovakia |
|
| South Korea |
|
| Spain |
|
| Taiwan |
|
| United States |
|
|
|
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|