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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPGH | Other Identifier | Eli Lilly and Company | |
| 2018-003422-84 | EudraCT Number |
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The purpose of this study is to compare the effect of the study drug tirzepatide to insulin degludec on blood sugar levels in participants with type 2 diabetes. The study will last about 67 weeks and may include up to 22 visits.
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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 Degludec | Active Comparator | Insulin degludec administered SC once 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) (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 Oral Antihyperglycemic Medication (OAM) Use (Metformin (Met), Met plus SGLT-2i) + Treatment + Time + Treatment*Time (Type III sum of squares). | Baseline, Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c (5 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 OAM Use (Met, Met plus SGLT-2i) + Treatment + Time + Treatment*Time (Type III sum of squares). |
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Inclusion Criteria:
Participants must:
Exclusion Criteria:
Participants must not:
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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 |
|---|---|---|---|---|---|---|
| Arkansas Clinical Research | Little Rock | Arkansas | 72205 | United States | ||
| Valley Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40318682 | Derived | Sattar N, Neeland IJ, Dahlqvist Leinhard O, Fernandez Lando L, Bray R, Linge J, Rodriguez A. Tirzepatide and muscle composition changes in people with type 2 diabetes (SURPASS-3 MRI): a post-hoc analysis of a randomised, open-label, parallel-group, phase 3 trial. Lancet Diabetes Endocrinol. 2025 Jun;13(6):482-493. doi: 10.1016/S2213-8587(25)00027-0. Epub 2025 Apr 30. | |
| 39531161 |
| Label | URL |
|---|---|
| A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes | 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 | 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. |
| FG001 | 10 mg Tirzepatide | 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 | Jul 30, 2020 | Aug 17, 2021 |
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| Insulin Degludec | Drug | Administered SC |
|
| Baseline, Week 52 |
| Change From Baseline in Body Weight | LS mean was determined by MMRM model with Baseline + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares) as covariates. | Baseline, Week 52 |
| Change From Baseline in Fasting Serum Glucose | LS mean was determined by MMRM model with variables Baseline + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares). | Baseline, Week 52 |
| Percentage of Participants Achieving an HbA1c Target Value of <7% | Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing. Missing endpoint measures are imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for Baseline Value, Pooled Country, Baseline OAM Use (Met, Met plus SGLT-2i), Treatment, Visit and Visit*Treatment. | Week 52 |
| Mean 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 Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. LS mean was determined by mixed-model repeated measures (MMRM) model with variables Baseline + Baseline HbA1c Group (<=8.5%, >8.5%) + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Treatment + Time + Treatment*Time (Type III sum of squares). | Baseline, Week 52 |
| Percentage of Participants Who Achieved Weight Loss ≥5% | Percentage of Participants who Achieved Weight Loss ≥5% | Week 52 |
| Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction Score | DTSQc, an 8-item questionnaire, assesses relative change in treatment satisfaction perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia from baseline to week 52 or early termination.The treatment satisfaction score ranges from -18 to 18 where the higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. The hyperglycemia and hypoglycemia scores range from -3 to 3 where negative scores indicate fewer problems with blood glucose levels and positive scores indicate more problems than before. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline DTSQs + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Baseline OAM Use (Met, Met plus SGLT-2i) + Treatment (Type III sum of squares). | Week 52 |
| Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 (Millimole/Liter (mmol/L))] or Severe Hypoglycemia | The hypoglycemia events were defined by participant reported events with blood glucose <54mg/dL (<3.0 mmol/L) or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model: Number of episodes = Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment, with log (exposure in days/365.25) as an offset variable. | Baseline through Safety Follow-Up (Up to Week 56) |
| Fresno |
| California |
| 93720 |
| United States |
| National Research Institute | Huntington Park | California | 90255 | United States |
| National Research Institute | Los Angeles | California | 90057 | United States |
| Catalina Research Institute, LLC | Montclair | California | 91763 | United States |
| Valley Clinical Trials, Inc. | Northridge | California | 91325 | United States |
| National Research Institute | Panorama City | California | 91402 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| University Clinical Investigators, Inc. | Tustin | California | 92780 | United States |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | United States |
| Indago Research & Health Center, Inc. | Hialeah | Florida | 33012 | United States |
| East Coast Clinical Research | Jacksonville | Florida | 32204 | United States |
| East Coast Institute For Research | Jacksonville | Florida | 32216 | United States |
| Bayside Clinical Research, LLC | New Port Richey | Florida | 34655 | United States |
| East Coast Institute For Research | Macon | Georgia | 31210 | United States |
| Sky Clinical Research Network | Union City | Georgia | 30291 | United States |
| Elite Clinical Trials LLLP | Blackfoot | Idaho | 83221 | United States |
| Humphreys Diabetes Center | Boise | Idaho | 83702 | United States |
| Rocky Mountain Diabetes and Osteoporosis Center | Idaho Falls | Idaho | 83404 | United States |
| Springfield Diabetes & Endocrine Center | Springfield | Illinois | 62711 | United States |
| Crescent City Clinical Research | Metairie | Louisiana | 70006 | United States |
| Endocrine and Metabolic Consultants | Rockville | Maryland | 20852 | United States |
| Troy Internal Medicine, PC | Troy | Michigan | 48098 | United States |
| International Diabetes Center | Minneapolis | Minnesota | 55416 | United States |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | United States |
| Palm Research Center | Las Vegas | Nevada | 89128 | United States |
| Palm Research Center | Las Vegas | Nevada | 89148 | United States |
| Aventiv Research | Columbus | Ohio | 43213 | United States |
| The Corvallis Clinic P.C. | Corvallis | Oregon | 97330 | United States |
| Heritage Valley Medical Group, Inc. | Beaver | Pennsylvania | 15009 | United States |
| Detweiler Family Medicine | Lansdale | Pennsylvania | 19446 | United States |
| Office of Dr. Osvaldo Brusco | Corpus Christi | Texas | 78414 | United States |
| Consano Clinical Research | Shavano Park | Texas | 78231 | United States |
| Mautalen Salud e Investigación - Servicio de Endocrinología | CABA | Buenos Aires | C1128AAF | Argentina |
| Investigaciones Medicas IMOBA S.R.L. | Caba | Buenos Aires | C1179AAB | Argentina |
| CEDIC-Centro de Investigaciones Clinicas | Caba | Buenos Aires | C1425DES | Argentina |
| Centro de Investigacion y Prevencion Cardiovascular (CIPREC) | Ciudad Autonoma de | Buenos Aires | C1119ACN | Argentina |
| CIPADI | Godoy Cruz | Mendoza Province | M5501ARP | Argentina |
| AXISMED SRL - Bioclinica Research Network | Buenos Aires | C1430CKE | Argentina |
| Centro Médico Viamonte | Ciudad Autonoma de Buenos Aire | C1120AAC | Argentina |
| Instituto Centenario | Ciudad Autonoma de Buenos Aire | C1204AAD | Argentina |
| CENUDIAB | Ciudad Autonoma de Buenos Aire | C1440AAD | Argentina |
| Landesklinikum Korneuburg-Stockerau, Standort Stockerau | Stockerau | Lower Austria | 2000 | Austria |
| Universitätsklinikum Graz | Graz | Styria | 8036 | Austria |
| Universitätsklinikum Salzburg | Salzburg | 5020 | Austria |
| KA Rudolfstiftung | Vienna | 1030 | Austria |
| Iatriko Palaiou Falirou, Medical Center | Palaió Fáliro | Athens | 17562 | Greece |
| Laiko General Hospital of Athens | Ampelokipoi | Attica | 11527 | Greece |
| Gen Hospital of Athens G Gennimatas | Athens | Attica | 11527 | Greece |
| General Hospital of Thessaloniki Papageorgiou | N. Efkarpia | Thessaloniki | 56403 | Greece |
| Thermi Clinic | Thermi | Thessaloniki | 57001 | Greece |
| Athens Euroclinic | Athens | 11521 | Greece |
| University General Hospital of Larissa | Larissa | 41110 | Greece |
| AHEPA Hospital | Thessaloniki | 54636 | Greece |
| Ippokrateio General Hospital of Thessaloniki | Thessaloniki | 54639 | Greece |
| Euromedica - General Clinic of Thessaloniki | Thessaloniki | 54645 | Greece |
| Kenezy Gyula Korhaz es Rendelointezet | Debrecen | Hajdú-Bihar | 4031 | Hungary |
| Szent Margit Rendelointezet | Budapest | 1032 | Hungary |
| ClinDiab Kft. | Budapest | 1089 | Hungary |
| XIII.ker Onkormanyzat Egeszsegugyi Szolgalat | Budapest | 1139 | Hungary |
| Strazsahegy Medicina Bt. | Budapest | 1171 | Hungary |
| TRANTOR 99 Bt. | Budapest | 1213 | Hungary |
| Kanizsai Dorottya Korhaz | Nagykanizsa | 8800 | Hungary |
| Zala Megyei Szent Rafael Korhaz | Zalaegerszeg | 8900 | Hungary |
| Azienda ospedaliero-universitaria Mater Domini | Germaneto | Catanzaro | 88100 | Italy |
| Policlinico Univ. Agostino Gemelli | Rome | Lazio | 00168 | Italy |
| Centro Cardiologico Monzino, IRCCS | Milan | MI | 20138 | Italy |
| Azienda Ospedaliera Policlinico Consorziale | Bari | 70124 | Italy |
| Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | 24128 | Italy |
| Ospedale Santa Maria Goretti | Latina | 04100 | Italy |
| Ambulatorium Barbara Bazela | Elblag | Warminsko-Mazurki | 82300 | Poland |
| NZOZ ZDROWIE Osteo-Medic | Bialystok | 15-351 | Poland |
| Poradnia Diabetologiczna SN ZOZ Lege Artis | Bialystok | 15-404 | Poland |
| NZOZ Diab-Endo-Met | Krakow | 31-261 | Poland |
| Gabinet Lekarski Malgorzata Saryusz-Wolska | Lodz | 90-132 | Poland |
| Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. | Lodz | 90-242 | Poland |
| NZOZ Przychodnia Specjalistyczna MEDICA | Lublin | 20-538 | Poland |
| NZOZ Przychodnia Specjalistyczna Henryk RudzkiAndrzej Wittek | Ruda Śląska | 41-709 | Poland |
| Latin Clinical Trial Center | San Juan | PR | 00909 | Puerto Rico |
| GCM Medical Group PSC | San Juan | PR | 00917 | Puerto Rico |
| San Miguel Medical | Trujillo Alto | PR | 00976 | Puerto Rico |
| S. C. Grandmed S.R.L., Str. | Oradea | Bihor County | 410159 | Romania |
| SC Diamed Obesity SRL | Galati | Galați County | 800291 | Romania |
| Spitalul Judetean de Urgenta Satu Mare | Satu Mare | Jud Satu-Mare | 440055 | Romania |
| CMI DNBM Dr. Pop Lavinia | Baia Mare | Maramureş | 430222 | Romania |
| Cosamext SRL | Târgu Mureş | Mureș County | 540098 | Romania |
| Societatea Civila Medicala "Dr. Paveliu" | Bucharest | Sect.5 | 050538 | Romania |
| Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL | Brasov | 500283 | Romania |
| Cabinetul Medical Nicodiab SRL | Bucharest | 010507 | Romania |
| SC Nutrilife SRL | Bucharest | 013671 | Romania |
| Consultmed SRL | Iași | 700547 | Romania |
| Bucheon St. Mary's Hospital | Bucheon-si | Gyeonggi-do | 14647 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Hanyang University Guri Hospital | Guri-si | Gyeonggido | 11923 | South Korea |
| Seoul St. Mary's Hospital | Seoul | Korea | 06591 | South Korea |
| Korea University Ansan Hospital | Ansan-si | 15355 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | 03722 | South Korea |
| Kyunghee University Hospital at Gangdong | Seoul | 05278 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital Infanta Luisa | Seville | Andalusia | 41010 | Spain |
| Hospital Universitario Marques De Valdecilla | Santander | Cantabria | 39011 | Spain |
| Hospital Universitario Quiron Madrid | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Instituto de Ciencias médicas | Alicante | 03004 | Spain |
| Hospital Clinico Universitario San Cecilio | Granada | 18016 | Spain |
| Clinica Juaneda | Palma de Mallorca | 07014 | Spain |
| Clinica Nuevas Tecnologias en Diabetes y Endocrinologia | Seville | 41003 | Spain |
| Policlinica Galileo | Teruel | 44002 | Spain |
| Changhua Christian Hospital | Changhua | 500 | Taiwan |
| Chang Gung Memorial Hospital - Kaohsiung | Kaohsiung City | 833 | Taiwan |
| Taipei Medical University- Shuang Ho Hospital | New Taipei City | 23561 | Taiwan |
| Chung Shan Medical University Hospital | Taichung | 40201 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705, ROC | Taiwan |
| Kuang Tien General Hospital | Taichung County | 433 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 70403 | Taiwan |
| Chi-Mei Medical Center | Tainan | 71004 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Dnipro City Clinical Hospital #9 | Dnipro | 49023 | Ukraine |
| V.P. Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine | Kyiv | 04114 | Ukraine |
| Communal Institution "Poltava Reg.Cl.H. n.a.M.V.Sklifosovskogo" | Poltava | 36011 | Ukraine |
| Vinnytsia Regional Clinical Highly Specialized Endocrinology Center | Vinnytsia | 21000 | Ukraine |
| De Block C, Peleshok J, Wilding JPH, Kwan AYM, Rasouli N, Maldonado JM, Wysham C, Liu M, Aleppo G, Benneyworth BD. Post Hoc Analysis of SURPASS-1 to -5: Efficacy and Safety of Tirzepatide in Adults with Type 2 Diabetes are Independent of Baseline Characteristics. Diabetes Ther. 2025 Jan;16(1):43-71. doi: 10.1007/s13300-024-01660-0. Epub 2024 Nov 12. |
| 38528819 | Derived | Cariou B, Linge J, Neeland IJ, Dahlqvist Leinhard O, Petersson M, Fernandez Lando L, Bray R, Rodriguez A. Effect of tirzepatide on body fat distribution pattern in people with type 2 diabetes. Diabetes Obes Metab. 2024 Jun;26(6):2446-2455. doi: 10.1111/dom.15566. Epub 2024 Mar 26. |
| 37668888 | Derived | Boye KS, Sapin H, Dong W, Williamson S, Lee CJ, Thieu VT. Improved Glycaemic and Weight Management Are Associated with Better Quality of Life in People with Type 2 Diabetes Treated with Tirzepatide. Diabetes Ther. 2023 Nov;14(11):1867-1887. doi: 10.1007/s13300-023-01457-7. Epub 2023 Sep 5. |
| 37526908 | Derived | Boye KS, Thieu VT, Sapin H, Lee CJ, Lando LF, Brown K, Bray R, Wiese RJ, Patel H, Rodriguez A, Yu M. Patient-Reported Outcomes in People with Type 2 Diabetes Receiving Tirzepatide in the SURPASS Clinical Trial Programme. Diabetes Ther. 2023 Nov;14(11):1833-1852. doi: 10.1007/s13300-023-01451-z. Epub 2023 Aug 1. |
| 37000390 | Derived | Viljoen A, Pantalone KM, Galindo RJ, Cui X, Huh R, Hemmingway A, Fernandez Lando L, Patel H. Time to Reach Glycaemic and Body Weight Loss Thresholds with Tirzepatide in Patients with Type 2 Diabetes: A Pre-planned Exploratory Analysis of SURPASS-2 and SURPASS-3. Diabetes Ther. 2023 May;14(5):925-936. doi: 10.1007/s13300-023-01398-1. Epub 2023 Mar 31. |
| 35468325 | Derived | Gastaldelli A, Cusi K, Fernandez Lando L, Bray R, Brouwers B, Rodriguez A. Effect of tirzepatide versus insulin degludec on liver fat content and abdominal adipose tissue in people with type 2 diabetes (SURPASS-3 MRI): a substudy of the randomised, open-label, parallel-group, phase 3 SURPASS-3 trial. Lancet Diabetes Endocrinol. 2022 Jun;10(6):393-406. doi: 10.1016/S2213-8587(22)00070-5. Epub 2022 Apr 22. |
| 35468321 | Derived | Battelino T, Bergenstal RM, Rodriguez A, Fernandez Lando L, Bray R, Tong Z, Brown K. Efficacy of once-weekly tirzepatide versus once-daily insulin degludec on glycaemic control measured by continuous glucose monitoring in adults with type 2 diabetes (SURPASS-3 CGM): a substudy of the randomised, open-label, parallel-group, phase 3 SURPASS-3 trial. Lancet Diabetes Endocrinol. 2022 Jun;10(6):407-417. doi: 10.1016/S2213-8587(22)00077-8. Epub 2022 Apr 22. |
| 35210595 | Derived | Sattar N, McGuire DK, Pavo I, Weerakkody GJ, Nishiyama H, Wiese RJ, Zoungas S. Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Nat Med. 2022 Mar;28(3):591-598. doi: 10.1038/s41591-022-01707-4. Epub 2022 Feb 24. |
| 34370970 | Derived | Ludvik B, Giorgino F, Jodar E, Frias JP, Fernandez Lando L, Brown K, Bray R, Rodriguez A. Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial. Lancet. 2021 Aug 14;398(10300):583-598. doi: 10.1016/S0140-6736(21)01443-4. Epub 2021 Aug 6. |
| FG002 | 15 mg Tirzepatide | 15 mg tirzepatide administered SC once a week SC. |
| FG003 | Insulin Degludec | Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values. |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 5 mg Tirzepatide | 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. |
| BG001 | 10 mg Tirzepatide | 10 mg tirzepatide administered SC once a week. |
| BG002 | 15 mg Tirzepatide | 15 mg tirzepatide administered SC once a week SC. |
| BG003 | Insulin Degludec | Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values. |
| 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. Hemoglobin A1c Analysis Population Description: All randomized participants who had a HbA1c baseline value. | 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) (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 Oral Antihyperglycemic Medication (OAM) Use (Metformin (Met), Met plus SGLT-2i) + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days) | Posted | Least Squares Mean | Standard Error | Percentage of HbA1c | Baseline, Week 52 |
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| Secondary | Change From Baseline in HbA1c (5 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 OAM Use (Met, Met plus SGLT-2i) + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days) | Posted | Least Squares Mean | Standard Error | Percentage of HbA1c | Baseline, 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 OAM Use (Met, Met plus SGLT-2i) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares) as covariates. | All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days) | 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 OAM Use (Met, Met plus SGLT-2i) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days) | Posted | Least Squares Mean | Standard Error | milligram per Deciliter (mg/dL) | Baseline, Week 52 |
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| Secondary | Percentage of Participants Achieving an HbA1c Target Value of <7% | Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing. Missing endpoint measures are imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for Baseline Value, Pooled Country, Baseline OAM Use (Met, Met plus SGLT-2i), Treatment, Visit and Visit*Treatment. | All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days) | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Mean 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 Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. LS mean was determined by mixed-model repeated measures (MMRM) model with variables Baseline + Baseline HbA1c Group (<=8.5%, >8.5%) + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days) | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, Week 52 |
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| Secondary | Percentage of Participants Who Achieved Weight Loss ≥5% | Percentage of Participants who Achieved Weight Loss ≥5% | All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days) | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction Score | DTSQc, an 8-item questionnaire, assesses relative change in treatment satisfaction perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia from baseline to week 52 or early termination.The treatment satisfaction score ranges from -18 to 18 where the higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. The hyperglycemia and hypoglycemia scores range from -3 to 3 where negative scores indicate fewer problems with blood glucose levels and positive scores indicate more problems than before. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline DTSQs + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Baseline OAM Use (Met, Met plus SGLT-2i) + Treatment (Type III sum of squares). | All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days) | Posted | Least Squares Mean | Standard Error | units on a scale | Week 52 |
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| Secondary | Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 (Millimole/Liter (mmol/L))] or Severe Hypoglycemia | The hypoglycemia events were defined by participant reported events with blood glucose <54mg/dL (<3.0 mmol/L) or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model: Number of episodes = Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment, with log (exposure in days/365.25) as an offset variable. | All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days) | Posted | Mean | Standard Error | Episodes/participant/365.25 days | Baseline through Safety Follow-Up (Up to Week 56) |
|
Baseline Up To 56 Weeks
All 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 | 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. | 1 | 358 | 29 | 358 | 124 | 358 |
| EG001 | 10 mg Tirzepatide | 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. | 2 | 360 | 20 | 360 | 157 | 360 |
| EG002 | 15 mg Tirzepatide | 15 mg tirzepatide administered SC once a week SC. | 1 | 359 | 26 | 359 | 179 | 359 |
| EG003 | Insulin Degludec | Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values. | 1 | 360 | 22 | 360 | 66 | 360 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Arrhythmogenic right ventricular dysplasia | Congenital, familial and genetic disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastritis alcoholic | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Segmental diverticular colitis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Necrosis | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Malignant biliary obstruction | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Cellulitis orbital | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Colon gangrene | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Covid-19 pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Hepatitis e | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Systemic candida | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Accident | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Maternal exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Tendon injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Sars-cov-2 test positive | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Gastric neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Invasive breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Lung adenocarcinoma stage iv | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Neuroendocrine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Testicular neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypoglycaemic unconsciousness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 23.1 | Systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Depression suicidal | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dry gangrene | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.1 | 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 | Jan 27, 2021 | Aug 17, 2021 | SAP_001.pdf |
Not provided
| 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 |
| C571886 | insulin degludec |
| 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 |
Not provided
Not provided
|
|
|
|
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| Austria |
|
|
| Greece |
|
|
| Hungary |
|
|
| Italy |
|
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| Poland |
|
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| Puerto Rico |
|
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| Romania |
|
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| South Korea |
|
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| Spain |
|
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| Taiwan |
|
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| Ukraine |
|
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| United States |
|
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| Mixed Models Analysis |
| <0.001 |
| LS Mean Difference |
| -1.04 |
| 2-Sided |
| 95 |
| -1.17 |
| -0.90 |
| Non-Inferiority |
The study was powered for superiority in HbA1c. The sample size provided >99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%. |
| Units | Counts |
|---|---|
| Participants |
|
|
|
Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.
The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values.
|
|
|
Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.
The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values.
|
|
|
| OG003 | Insulin Degludec | Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values. |
|
|
|
15 mg tirzepatide administered SC once a week SC.
| OG003 | Insulin Degludec | Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values. |
|
|
|
|
|
10 mg tirzepatide administered SC once a week. |
| OG002 | 15 mg Tirzepatide | 15 mg tirzepatide administered SC once a week SC. |
| OG003 | Insulin Degludec | Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values. |
|
|
|
| OG002 | 15 mg Tirzepatide | 15 mg tirzepatide administered SC once a week SC. |
| OG003 | Insulin Degludec | Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values. |
|
|
| Title | Measurements |
|---|---|
|
|