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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPGI | Other Identifier | Eli Lilly and Company | |
| 2019-000860-99 | EudraCT Number |
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The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to placebo in participants with type 2 diabetes that are already on insulin glargine, with or without metformin. Participants will administer tirzepatide or placebo along with their previous glucose lowering medications. The study will last approximately 47 weeks and may include about 23 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. |
|
| Placebo | Placebo Comparator | Placebo administered SC once a week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC as add-on to the pre-trial background medication. |
|
| 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 Baseline + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares). | Baseline, Week 40 |
| 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 Baseline + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares). |
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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 |
|---|---|---|---|---|---|---|
| Valley Endocrine, Fresno | Fresno | California | 93720 | United States | ||
| Sun Coast Clinical Research, Inc |
| 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. | |
| 39531161 | Derived |
| Label | URL |
|---|---|
| A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin | 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 |
|
Not provided
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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 | Jun 26, 2020 | Jul 7, 2021 |
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|
| Placebo | Drug | Administered SC as add-on to the pre-trial background medication. |
|
| Baseline, Week 40 |
| Change From Baseline in Body Weight | Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Baseline HbA1c Group (<= 8.0%, >8.0%) + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares). | Baseline, Week 40 |
| 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. | Week 40 |
| Change From Baseline in Fasting Serum Glucose | Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. LS Mean was determined by MMRM model with Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (<= 8.0%, >8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | Baseline, Week 40 |
| 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. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Baseline HbA1c Group (<= 8.0%, >8.0%) + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment (Type III sum of squares). | Baseline, Week 40 |
| Percentage of Participants Who Achieved Weight Loss ≥5% | Percentage of Participants who Achieved Weight Loss ≥5%. | Week 40 |
| Percentage Change From Baseline in Daily Mean Insulin Glargine Dose | LS mean was calculated using MMRM model with log (Baseline) + Baseline Metformin Use (Yes, No) + Pooled Country + Baseline HbA1c Group (<= 8.0%, >8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | Baseline, Week 40 |
| 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 Metformin Use (Yes, No) + Baseline HbA1c Group (<= 8.0%, >8.0%) + Treatment, with log (exposure in days/365.25) as an offset variable. | Baseline through Safety Follow-Up (Up to Week 44) |
| Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide | AUC is a combined measure obtained from Week 7, 15, 23 and 39 and a single averaged measure of AUC was reported. | Week 7, 15, 23 and 39 post dose |
| Percentage of Participants Achieving an HbA1c Target Value of <5.7% | Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. | Week 40 |
| New Port Richey |
| Florida |
| 34652 |
| United States |
| Southern New Hampshire Diabetes and Endocrinology | Nashua | New Hampshire | 03063 | United States |
| Manhattan Medical Research | New York | New York | 10016 | United States |
| Intend Research | Norman | Oklahoma | 73069 | United States |
| Milan Kvapil s.r.o. | Příbram | Central Bohemia | 26201 | Czechia |
| Diacentrum Brandys n.L. s.r.o. | Brandys Nad Labem-Stara Bolesl | 25001 | Czechia |
| Diabetologicka ordinace pro dospele | Krnov | 79401 | Czechia |
| Diahelp s.r.o., Interni a diabetologicka ambulance | Pardubice | 53002 | Czechia |
| Lekarna Dr. Max | Prague | 11000 | Czechia |
| Milan Kvapil s.r.o. | Prague | 149 00 | Czechia |
| RESTRIAL s.r.o. | Prague | 181 00 | Czechia |
| Praxis Dr. Jörg Lüdemann | Falkensee | Brandenburg | 14612 | Germany |
| Arztpraxis Dr. Cornelia Marck | Pohlheim | Hesse | 35415 | Germany |
| InnoDiab Forschung GmbH | Essen | North Rhine-Westphalia | 45136 | Germany |
| Institut für Diabetesforschung Münster GmbH | Münster | North Rhine-Westphalia | 48145 | Germany |
| Praxis Dr. Kempe - Dr. Stemler | Ludwigshafen am Rhein | Rhineland-Palatinate | 67059 | Germany |
| Schwerpunktpraxis Diabetes | Saint Ingbert-Oberwürzbach | Saarland | 66386 | Germany |
| SMO.MD GmbH | Magdeburg | Saxony-Anhalt | 39112 | Germany |
| RED-Institut GmbH | Oldenburg in Holstein | Schleswig-Holstein | 23758 | Germany |
| Diabetologische Schwerpunktpraxis B. Scholz/Dr. B. Paschen | Hamburg | 21073 | Germany |
| Gemeinschaftspraxis für innere Medizin und Diabetologie | Hamburg | 22607 | Germany |
| Kashiwa hospital | Kashiwa | Chiba | 277-0825 | Japan |
| Manda Hospital | Sapporo | Hokkaido | 060-0062 | Japan |
| Takai Naika Clinic | Kamakura | Kanagawa | 247-0056 | Japan |
| Takatsuki Red Cross Hospital | Takatsuki | Osaka | 569-1096 | Japan |
| Tokyo-Eki Center-building Clinic | Chuo-ku | Tokyo | 103-0027 | Japan |
| Tokyo Center Clinic | Chuo-ku | Tokyo | 103-0028 | Japan |
| Tokyo Clinical Trial Centre Fukuwa Clinic | Chuo-ku | Tokyo | 104-0031 | Japan |
| The Institute for Adult Diseases, Asahi Life Foundation | Chuou-ku | Tokyo | 1030002 | Japan |
| Sato Naika Clinic | Ōta-ku | Tokyo | 143-0015 | Japan |
| Jinnouchi Hospital | Kumamoto | 862-0976 | Japan |
| Centrum Medyczne AMED | Warsaw | Masovian Voivodeship | 01-518 | Poland |
| NZOZ ZDROWIE Osteo-Medic | Bialystok | Podlaskie Voivodeship | 15-351 | Poland |
| Centrum Badan Klinicznych, PI House | Gdansk | Pomeranian Voivodeship | 80-546 | Poland |
| NZOZ Przychodnia Specjalistyczna MEDICA | Lublin | 20-538 | Poland |
| Centro de Endocrinologia y Nutricion del Turabo | Caguas | PR | 00725 | Puerto Rico |
| Manati Center for Clinical Research Inc | Manati | PR | 00674 | Puerto Rico |
| Ambulancia vnútorného lekárstva Hnúša (Diabetes care) | Hnúšťa | 98101 | Slovakia |
| Sin Azucar | Malacky | 901 01 | Slovakia |
| Dia-Clarus.s.r.o. | Prievidza | 971 01 | Slovakia |
| JAL | Trnava | 917 01 | Slovakia |
| Medivasa, s.r.o. | Žilina | 01001 | Slovakia |
| Hospital Clinico Universitario Virgen de la Victoria | Málaga | Andalusia | 29010 | Spain |
| Hospital de la Ribera | Alzira | Valencia | 46600 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Infanta Luisa | Seville | 41010 | Spain |
| Hospital Universitari i Politecnic La Fe-ENDO | Valencia | 46026 | Spain |
| 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. |
| 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. |
| 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. |
| 35133415 | Derived | Dahl D, Onishi Y, Norwood P, Huh R, Bray R, Patel H, Rodriguez A. Effect of Subcutaneous Tirzepatide vs Placebo Added to Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes: The SURPASS-5 Randomized Clinical Trial. JAMA. 2022 Feb 8;327(6):534-545. doi: 10.1001/jama.2022.0078. |
| FG002 | 15 mg Tirzepatide | 15 mg tirzepatide administered SC once a week. |
| FG003 | Placebo | Placebo administered SC once a week. |
| 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. |
| BG003 | Placebo | Placebo administered SC once a week. |
| 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) (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 Baseline + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized participants from who received at least 1 dose study drug and had a baseline and at least 1 post-baseline value, excluding patients 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 40 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 Baseline + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized participants who received at least one dose of 5 mg tirzepatide, placebo and had a baseline and at least 1 post-baseline value, excluding patients discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication. | Posted | Least Squares Mean | Standard Error | Percentage of HbA1c | Baseline, Week 40 |
|
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| Secondary | Change From Baseline in Body Weight | Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Baseline HbA1c Group (<= 8.0%, >8.0%) + Baseline Metformin Use (Yes, No) + Pooled Country + 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, excluding patients 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 40 |
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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. | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding patients 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 40 |
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| Secondary | Change From Baseline in Fasting Serum Glucose | Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. LS Mean was determined by MMRM model with Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (<= 8.0%, >8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding patients 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 40 |
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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. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Baseline HbA1c Group (<= 8.0%, >8.0%) + Baseline Metformin Use (Yes, No) + Pooled Country + 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, excluding patients 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 | Baseline, Week 40 |
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| Secondary | Percentage of Participants Who Achieved Weight Loss ≥5% | Percentage of Participants who Achieved Weight Loss ≥5%. | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding patients 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 40 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in Daily Mean Insulin Glargine Dose | LS mean was calculated using MMRM model with log (Baseline) + Baseline Metformin Use (Yes, No) + Pooled Country + Baseline HbA1c Group (<= 8.0%, >8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding patients 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 | International Units (IU) | Baseline, Week 40 |
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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 Metformin Use (Yes, No) + Baseline HbA1c Group (<= 8.0%, >8.0%) + Treatment, with log (exposure in days/365.25) as an offset variable. | All randomly assigned participants who took at least 1 dose of study drug. | Posted | Mean | Standard Error | Episodes/participant/365.25 days | Baseline through Safety Follow-Up (Up to Week 44) |
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| Secondary | Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide | AUC is a combined measure obtained from Week 7, 15, 23 and 39 and a single averaged measure of AUC was reported. | All randomized participants who received at least one dose and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | Week 7, 15, 23 and 39 post dose |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving an HbA1c Target Value of <5.7% | Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding patients 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 40 |
|
Baseline, 17 Months
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 | 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. | 0 | 116 | 9 | 116 | 52 | 116 |
| EG001 | 10 mg Tirzepatide | 10 mg tirzepatide administered SC once a week. | 0 | 119 | 13 | 119 | 60 | 119 |
| EG002 | 15 mg Tirzepatide | 15 mg tirzepatide administered SC once a week. | 0 | 120 | 9 | 120 | 67 | 120 |
| EG003 | Placebo | Placebo administered SC once a week. | 0 | 120 | 10 | 120 | 58 | 120 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure | 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 |
| |
| Tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pancreatic disorder | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Covid-19 pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Intestinal anastomosis complication | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Papillary renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Renal 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 |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Hypoglycaemic unconsciousness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Orthostatic intolerance | 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 |
| |
| Anxiety | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bladder disorder | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dyspnoea | 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 |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac ablation | Surgical and medical procedures | MedDRA 23.1 | Systematic Assessment |
| |
| Pancreatic lesion excision | Surgical and medical procedures | MedDRA 23.1 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Flatulence | 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 |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue 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 | Feb 1, 2021 | Jul 7, 2021 | 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 |
| 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
| 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 |
|
| Germany |
|
| Japan |
|
| Poland |
|
| Puerto Rico |
|
| Slovakia |
|
| Spain |
|
| United States |
|
| LS Mean Difference |
| -1.65 |
| 2-Sided |
| 95 |
| -1.88 |
| -1.43 |
| Superiority |
|
|
Placebo administered SC once a week.
|
|
|
|
|
|
Placebo administered SC once a week. |
|
|
|
| OG003 | Placebo | Placebo administered SC once a week. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Placebo administered SC once a week.
|
|
|
15 mg tirzepatide administered SC once a week.
| OG003 | Placebo | Placebo administered SC once a week. |
|
|
|
|
|
|