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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPHD | Other Identifier | Eli Lilly and Company | |
| 2020-000284-23 | EudraCT Number |
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The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to insulin lispro (U100) three times a day in participants with type 2 diabetes that are already on insulin glargine (U100), with or without metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 mg Tirzepatide | Experimental | 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. |
|
| 10 mg Tirzepatide | Experimental | 10 mg tirzepatide administered SC once a week. |
|
| 15 mg Tirzepatide | Experimental | 15 mg tirzepatide administered SC once a week. |
|
| Insulin Lispro | Active Comparator | Insulin lispro 100 units per milliliter (U100) administered SC three times a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares). | Baseline, Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model with covariates Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares). | Baseline, Week 52 |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Syed Research Consultants Llc | Sheffield | Alabama | 35660 | United States | ||
| Valley Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41961454 | Derived | Bajaj HS, Billings LK, Sharma P, Levine JA, Rodriguez A, Patel H. Tirzepatide as an Add-on for Participants with Inadequate Glycemic Control Using Basal Insulin: Pooled Subgroup Analysis of SURPASS-5 and -6. Diabetes Ther. 2026 May;17(5):787-797. doi: 10.1007/s13300-026-01859-3. Epub 2026 Apr 10. | |
| 37786396 | Derived |
| Label | URL |
|---|---|
| A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin (SURPASS-6) | 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 US and 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 | 5 mg Tirzepatide | Participants received 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. |
| FG001 | 10 mg Tirzepatide | Participants received 10 mg tirzepatide administered SC once a week . |
| 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 | Jan 29, 2021 | Sep 11, 2023 |
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| Insulin Lispro (U100) | Drug | Administered SC |
|
|
| Percentage of Participants With HbA1c Target Values <7.0% | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. | Week 52 |
| Change From Baseline in Body Weight | LS mean was determined by MMRM model with Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares). | Baseline, Week 52 |
| Change From Baseline in Fasting Serum Glucose | LS mean was determined by MMRM model with variables Baseline + Pooled Country + Baseline metformin Use (Yes, No) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares). | Baseline, Week 52 |
| Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values | The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post meal, Midday Premeal, Midday 2-hour Post meal, Evening Premeal, Evening 2-hour Post meal and Bedtime. The daily average was calculated as the average of the 7 blood glucose values collected on a particular day. LS mean was determined by MMRM model with variables Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares). | Baseline, Week 52 |
| Percentage of Participants Who Achieved HbA1c Target Value of <7.0% Without Hypoglycemia | Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. | Week 52 |
| Percentage of Participants Who Achieved Weight Loss ≥5% | Percentage of Participants who Achieved Weight Loss ≥5% is reported here. | Week 52 |
| Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score | The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. PCS score is reported here. PCS domain is scored by summing individual items and transforming scores into a 0 to 100 scale with higher scores indicating better health status or functioning. LS mean was determined by analysis of covariance (ANCOVA) model with variables Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment (Type III sum of squares). | Baseline, Week 52 |
| Change From Baseline in 36-Item SF-36 Mental Component Summary (MCS) Score | The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. MCS consisted of social functioning, vitality, mental health, and role-emotional scales. MCS score is reported here. MCS domain is scored by summing individual items and transforming scores into a 0 to 100 scale with higher scores indicating better health status or functioning. LS mean was determined by ANCOVA model with variables Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment (Type III sum of squares). | Baseline, Week 52 |
| Fresno |
| California |
| 93720 |
| United States |
| National Research Institute - Huntington Park | Huntington Park | California | 90255 | United States |
| National Research Institute - Huntington Park | Los Angeles | California | 90057 | United States |
| Valley Clinical Trials, Inc. | Northridge | California | 91325 | United States |
| National Research Institute - Huntington Park | Panorama City | California | 91402 | United States |
| National Research Institute (NRI) - Santa Ana | Santa Ana | California | 92704 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| University Clinical Investigators, Inc. | Tustin | California | 92780 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| Excel Medical Clinical Trials | Boca Raton | Florida | 33434 | United States |
| I R & Health Center, Inc. | Hialeah | Florida | 33012 | United States |
| Sun Coast Clinical Research, Inc | New Port Richey | Florida | 34652 | United States |
| South Broward Research | Pembroke Pines | Florida | 33027 | United States |
| Metabolic Research Institute, Inc. | West Palm Beach | Florida | 33401 | United States |
| Rocky Mountain Clinical Research | Idaho Falls | Idaho | 83404 | United States |
| J H. Stroger Hosp of Cook Co | Chicago | Illinois | 60612 | United States |
| Prairie Education and Research Cooperative | Springfield | Illinois | 62711 | United States |
| Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa | 50265 | United States |
| Capital Diabetes and Endocrine Associates | Camp Springs | Maryland | 20746 | United States |
| MedStar Health Research Institute | Hyattsville | Maryland | 20782 | United States |
| Endocrine and Metabolic Consultants | Rockville | Maryland | 20852 | United States |
| Glacier View Research Institute - Endocrinology | Kalispell | Montana | 59901 | United States |
| Southern Nh Diabetes and Endocrinology | Nashua | New Hampshire | 03060 | United States |
| Albany Medical College | Albany | New York | 12203 | United States |
| PMG Research of Wilmington | Wilmington | North Carolina | 28401 | United States |
| Intend Research, LLC | Norman | Oklahoma | 73069 | United States |
| Heritage Valley Medical Group, Inc. | Beaver | Pennsylvania | 15009 | United States |
| Preferred Primary Care Physicians | Uniontown | Pennsylvania | 15401 | United States |
| Tribe Clinical Research, LLC | Greenville | South Carolina | 29607 | United States |
| Dallas Diabetes Research Center | Dallas | Texas | 75230 | United States |
| Diabetes and Thyroid Center of Fort Worth | Fort Worth | Texas | 76132 | United States |
| Juno Research | Houston | Texas | 77040 | United States |
| Biopharma Informatic, LLC | Houston | Texas | 77084 | United States |
| North Hills Medical Research | North Richland Hills | Texas | 76180 | United States |
| Texas Diabetes & Endocrinology, P.A. | Round Rock | Texas | 78681 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | United States |
| Martin Diagnostic Clinic | Tomball | Texas | 77375 | United States |
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
| Centro Médico Viamonte | CABA | Buenos Aires | C1120AAC | Argentina |
| Investigaciones Medicas Imoba Srl | CABA | Buenos Aires | C1179AAB | Argentina |
| Instituto Centenario | CABA | Buenos Aires | C1204AAD | Argentina |
| Instituto de Investigaciones Clínicas Rosario (IIC-Rosario)- Sanatorio Delta | Rosario | Buenos Aires | S2000BIF | Argentina |
| CIPADI | Godoy Cruz | Mendoza Province | M5501ARP | Argentina |
| Instituto Médico Catamarca | Rosario | Santa Fe Province | 2000 | Argentina |
| Instituto Médico Especializado (IME) | Buenos Aires | 1405 | Argentina |
| Asociación de Beneficencia Hospital Sirio Libanés | Buenos Aires | C1419AHN | Argentina |
| CENUDIAB | Ciudad Autónoma de Buenos Aire | C1440AAD | Argentina |
| Centro Diabetologico Dr Waitman | Córdoba | 5000 | Argentina |
| Centro Medico Privado San Vicente Diabetes | Córdoba | X5006CBI | Argentina |
| Sanatorio Parque | Salta | 4400 | Argentina |
| AZ Damiaan Oostende | Ostend | 8400 | Belgium |
| Centro de Pesq. em Diabetes e Doencas Endocrino Metabol. | Fortaleza | Ceará | 60430-350 | Brazil |
| CEDOES | Vitória | Espírito Santo | 29055-450 | Brazil |
| Cline Research Center | Curitiba | Paraná | 80030 | Brazil |
| QUANTA - Medicina Nuclear Alto da XV | Curitiba | Paraná | 80045-170 | Brazil |
| Centro de Pesquisas em Diabetes | Porto Alegre | Rio Grande do Sul | 90430-001 | Brazil |
| Hospital PUC-CAMPINAS | Campinas | São Paulo | 13060-904 | Brazil |
| CECIP - Centro de Estudos do Interior Paulista | Jaú | São Paulo | 17201-130 | Brazil |
| CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda | São Bernardo do Campo | São Paulo | 09715-090 | Brazil |
| ISPEM - Instituto São José dos Campos em Pesquisas Médicas | São José dos Campos | São Paulo | 12243-280 | Brazil |
| CPCLIN | São Paulo | São Paulo | 01228-200 | Brazil |
| Instituto Brasil de Pesquisa Clínica - IBPCLIN | Rio de Janeiro | 20241180 | Brazil |
| IPEC - Instituto de Pesquisa Clínica | São Paulo | 01223-001 | Brazil |
| CPQuali Pesquisa Clínica | São Paulo | 01228-000 | Brazil |
| BR Trials - Ensaios Clínicos e Consultoria Ltda | São Paulo | 03325-050 | Brazil |
| CEPIC - Centro Paulista de Investigação Clínica | São Paulo | 04266-010 | Brazil |
| Diabetologicka ordinace pro dospele | Krnov | Moravian-Silesian Region | 79401 | Czechia |
| Diabetologicka a obezitologicka ambulance | České Budějovice | 370 11 | Czechia |
| Diahelp s.r.o., Interni a diabetologicka ambulance | Pardubice | 530 02 | Czechia |
| ResTrial s.r.o. | Prague | 181 00 | Czechia |
| Schwerpunktpraxis für Diabetes | Hof | Bavaria | 95030 | Germany |
| InnoDiab Forschung Gmbh | Essen | North Rhine-Westphalia | 45136 | Germany |
| Medizentrum Essen-Borbeck | Essen | North Rhine-Westphalia | 45355 | Germany |
| Zentrum für klinische Studien | Saint Ingbert | Saarland | 66386 | Germany |
| RED-Institut GmbH | Oldenburg in Holstein | Schleswig-Holstein | 23758 | Germany |
| MVZ im Altstadt-Carree Fulda GmbH | Fulda | 36037 | Germany |
| Diabetologische Schwerpunktpraxis Harburg | Hamburg | 21073 | Germany |
| Diabeteszentrum Hamburg West | Hamburg | 22607 | Germany |
| Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf | Wallerfing | 94574 | Germany |
| Iatriko Palaiou Falirou, Medical Center | Palaió Fáliro | Athens | 17562 | Greece |
| Athens Euroclinic | Athens | Attica | 11521 | Greece |
| General Hospital of Thessaloniki Papageorgiou | N. Efkarpia | Thessaloniki | 56403 | Greece |
| Thermi Clinic | Thermi | Thessaloniki | 57001 | Greece |
| Belinus Bt | Debrecen | Hajdú-Bihar | 4025 | Hungary |
| Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Intezet | Debrecen | Hajdú-Bihar | 4032 | Hungary |
| Szent Margit Rendelőintézet Nonprofit Kft | Budapest | 1032 | Hungary |
| TRANTOR'99 Bt. Anyagcsere Centrum | Budapest | 1213 | Hungary |
| Policlinico Mater Domini | Germaneto | Catanzaro | 88100 | Italy |
| Casa di Cura Multimedica-Policlinico Multispecialistico | Sesto San Giovanni | MI | 20099 | Italy |
| Ospedale Luigi Sacco | Milan | 20157 | Italy |
| Policlinico Univ. Agostino Gemelli | Roma | 00168 | Italy |
| Instituto Jalisciense de Investigacion en Diabetes y Obesida | Guadalajara | Jalisco | 44600 | Mexico |
| Unidad de patologia Clinica | Guadalajara | Jalisco | 44650 | Mexico |
| Centro de Inv. Medica de Occidente, SC | Zapopan | Jalisco | 45116 | Mexico |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | N.L. | 64460 | Mexico |
| Centro de Estudios de Investigacion Metabolicos y Cardiovasculares | Madero | Tamaulipas | 89440 | Mexico |
| Centro de Endocrinologia y Nutricion del Turabo | Caguas | PR | 00726 | Puerto Rico |
| Paola Mansilla-Letelier, MD | Guaynabo | PR | 00970 | Puerto Rico |
| SC Endodigest SRL | Oradea | Bihor County | 410151 | Romania |
| S. C. Grandmed S.R.L. | Oradea | Bihor County | 410159 | Romania |
| C.M.D.T.A. Neomed | Brasov | Brașov County | 500283 | Romania |
| SC Gama Diamed SRL | Mangalia | Constanța County | 905500 | Romania |
| CMI DNBM Dr. Pop Lavinia | Baia Mare | Maramureş | 430222 | Romania |
| SC Cosamext SRL | Târgu Mureş | Mureș County | 540098 | Romania |
| SC Diabmed Dr Popescu Alexandrina SRL | Ploieşti | Prahova | 100179 | Romania |
| SC Dianutrilife Medica SRL | Ploieşti | Prahova | 100561 | Romania |
| Centrul Medical Dr. Negrisanu | Timișoara | Timiș County | 300456 | Romania |
| Cabinetul Medical Nicodiab SRL | Bucharest | 010507 | Romania |
| SC Nutrilife SRL | Bucharest | 013671 | Romania |
| Milena Sante SRL | Galati | 800001 | Romania |
| Arkhangelsk Regional Clinical Hospital | Arkhangelsk | 163045 | Russia |
| Scientific and Clinical Center for Precision and Regenerative Medicine | Kazan' | 420012 | Russia |
| Pirogov Russian National Research Medical University | Moscow | 109263 | Russia |
| First Moscow State Medical University | Moscow | 119435 | Russia |
| City Consultative and Diagnostic Center #1 | Saint Petersburg | 194354 | Russia |
| Saint-Petersburg State Budgetary Institution of Healthcare Institution | Saint Petersburg | 194354 | Russia |
| St.Petersburg Polyclinic #117 | Saint Petersburg | 194358 | Russia |
| SPb GUZ "Diagnostic Center #85" | Saint Petersburg | 198255 | Russia |
| Diacrin s.r.o. | Bratislava | Bratislava Region | 841 02 | Slovakia |
| MediVet s.r.o. | Malacky | Bratislava Region | 901 01 | Slovakia |
| Human care s.r.o. | Košice | Slovak Republic | 04012 | Slovakia |
| Diabetes care s.r.o. | Hnúšťa | 98101 | Slovakia |
| Areteus s.r.o. | Trebišov | 075 01 | Slovakia |
| Hospital Quiron Infanta Luisa | Seville | Andalusia | 41010 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | Cantabria | 39011 | Spain |
| Complejo Hospitalario Universitario De Ferrol - Hospital Naval | Ferrol | La Coruna | 15405 | Spain |
| Clínica Juaneda | Palma de Mallorca | 07014 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Baskent Universitesi Adana Uygulama ve Arastirma Merkezi Yuregir Hastanesi | Adana | 01240 | Turkey (Türkiye) |
| Akdeniz University Medical Faculty | Antalya | 07059 | Turkey (Türkiye) |
| Aydin Adnan Menderes Universitesi | Aydin | 09010 | Turkey (Türkiye) |
| Gaziantep University Medical Faculty | Gaziantep | 27310 | Turkey (Türkiye) |
| Inonu Universitesi | Malatya | 44282 | Turkey (Türkiye) |
| Rosenstock J, Frias JP, Rodbard HW, Tofe S, Sears E, Huh R, Fernandez Lando L, Patel H. Tirzepatide vs Insulin Lispro Added to Basal Insulin in Type 2 Diabetes: The SURPASS-6 Randomized Clinical Trial. JAMA. 2023 Nov 7;330(17):1631-1640. doi: 10.1001/jama.2023.20294. |
| FG002 | 15 mg Tirzepatide | Participants received 15 mg tirzepatide administered SC once a week. |
| FG003 | Insulin Lispro | Participants received Insulin lispro 100 units per milliliter (U100) administered SC three times a day. |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 5 mg Tirzepatide | Participants received 5 mg tirzepatide administered SC once a week. |
| BG001 | 10 mg Tirzepatide | Participants received 10 mg tirzepatide administered SC once a week. |
| BG002 | 15 mg Tirzepatide | Participants received 15 mg tirzepatide administered SC once a week. |
| BG003 | Insulin Lispro | Participants received Insulin lispro (U100) administered SC three times a day. |
| BG004 | 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 |
| |||||||||||||||
| Hemoglobin A1c | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily 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) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide. | Posted | Least Squares Mean | Standard Error | Percentage of HbA1c | Baseline, Week 52 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HbA1c | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model with covariates Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug. | Posted | Least Squares Mean | Standard Error | Percentage of HbA1c | Baseline, Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HbA1c Target Values <7.0% | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug. | Posted | Number | Percentage of participants | Week 52 |
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| Secondary | Change From Baseline in Body Weight | LS mean was determined by MMRM model with Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug. | Posted | Least Squares Mean | Standard Error | Kilograms (kg) | Baseline, Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Serum Glucose | LS mean was determined by MMRM model with variables Baseline + Pooled Country + Baseline metformin Use (Yes, No) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug. | Posted | Least Squares Mean | Standard Error | milligram per Deciliter (mg/dL) | Baseline, Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values | The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post meal, Midday Premeal, Midday 2-hour Post meal, Evening Premeal, Evening 2-hour Post meal and Bedtime. The daily average was calculated as the average of the 7 blood glucose values collected on a particular day. LS mean was determined by MMRM model with variables Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug. | Posted | Least Squares Mean | Standard Error | mg/dL/day | Baseline, Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved HbA1c Target Value of <7.0% Without Hypoglycemia | Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug. | Posted | Number | Percentage of participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Weight Loss ≥5% | Percentage of Participants who Achieved Weight Loss ≥5% is reported here. | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug. | Posted | Number | Percentage of participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score | The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. PCS score is reported here. PCS domain is scored by summing individual items and transforming scores into a 0 to 100 scale with higher scores indicating better health status or functioning. LS mean was determined by analysis of covariance (ANCOVA) model with variables Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment (Type III sum of squares). | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 36-Item SF-36 Mental Component Summary (MCS) Score | The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. MCS consisted of social functioning, vitality, mental health, and role-emotional scales. MCS score is reported here. MCS domain is scored by summing individual items and transforming scores into a 0 to 100 scale with higher scores indicating better health status or functioning. LS mean was determined by ANCOVA model with variables Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment (Type III sum of squares). | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this analysis, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 52 |
|
Baseline up to week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring 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 | 5 mg Tirzepatide | Participants received 5 mg tirzepatide administered SC once a week. | 3 | 243 | 20 | 243 | 94 | 243 |
| EG001 | 10 mg Tirzepatide | Participants received 10 mg tirzepatide administered SC once a week. | 3 | 238 | 16 | 238 | 116 | 238 |
| EG002 | 15 mg Tirzepatide | Participants received 15 mg tirzepatide administered SC once a week. | 1 | 236 | 17 | 236 | 121 | 236 |
| EG003 | Insulin Lispro | Participants received Insulin lispro (U100) administered SC three times a day. | 11 | 708 | 81 | 708 | 99 | 708 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Colonic fistula | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diabetic gastropathy | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Bullous erysipelas | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Covid-19 pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Diabetic foot infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Diabetic gangrene | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Oophoritis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Postoperative abscess | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Spinal disorder | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Oral neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypoglycaemic coma | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypoglycaemic unconsciousness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 25.1 | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Renal mass | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Aortic valve replacement | Surgical and medical procedures | MedDRA 25.1 | Systematic Assessment |
| |
| Arthrodesis | Surgical and medical procedures | MedDRA 25.1 | Systematic Assessment |
| |
| Coronary artery bypass | Surgical and medical procedures | MedDRA 25.1 | Systematic Assessment |
| |
| Retinal cryoablation | Surgical and medical procedures | MedDRA 25.1 | Systematic Assessment |
| |
| Umbilical hernia repair | Surgical and medical procedures | MedDRA 25.1 | Systematic Assessment |
| |
| Giant cell arteritis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 08005455979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 31, 2022 | Sep 11, 2023 | 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 |
|---|---|
| D000098860 | Tirzepatide |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
Not provided
Not provided
| 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 |
|
| Belgium |
|
| Brazil |
|
| Czechia |
|
| Germany |
|
| Greece |
|
| Hungary |
|
| Italy |
|
| Mexico |
|
| Romania |
|
| Russia |
|
| Slovakia |
|
| Spain |
|
| Turkey |
|
| United States |
|
| Insulin Lispro |
Participants received Insulin lispro (U100) administered SC three times a day. |
|
|
|
|
|
|
Participants received Insulin lispro (U100) administered SC three times a day.
|
|
|
Participants received Insulin lispro (U100) administered SC three times a day. |
|
|
|
Participants received 15 mg tirzepatide administered SC once a week. |
| OG003 | Insulin Lispro | Participants received Insulin lispro (U100) administered SC three times a day. |
|
|
|
Participants received Insulin lispro (U100) administered SC three times a day.
|
|
|
|
|
|
Participants received 10 mg tirzepatide administered SC once a week. |
| OG002 | 15 mg Tirzepatide | Participants received 15 mg tirzepatide administered SC once a week. |
| OG003 | Insulin Lispro | Participants received Insulin lispro (U100) administered SC three times a day. |
|
|
|
Participants received 10 mg tirzepatide administered SC once a week.
| OG002 | 15 mg Tirzepatide | Participants received 15 mg tirzepatide administered SC once a week. |
| OG003 | Insulin Lispro | Participants received Insulin lispro (U100) administered SC three times a day. |
|
|
|