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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPIL | Other Identifier | Eli Lilly and Company | |
| 2022-002708-18 | EudraCT Number |
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The main purpose of this study is to investigate the effects of switching from glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy to tirzepatide glucose-dependent insulinotropic polypeptide (GIP) GLP-1 RA agonist in participants with type 2 diabetes (T2D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 milligrams (mg) Tirzepatide | Experimental | Participants received 5 mg tirzepatide subcutaneously administered once weekly for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Percentage of Time Per Day That Continuous Glucose Monitoring (CGM)-Derived Values Were >180 Milligram/Deciliter (mg/dl) (10 Millimole/Liter (mmol/L)) | Change from Baseline in Percentage of Time per Day that CGM-derived Values were >180 mg/dl (10 mmol/L) was assessed. | Baseline, Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
Have Type 1 Diabetes (T1D)
Have a clinical history of
Are at high risk for cardiovascular disease or have a history of
Have New York Heart Association (NYHA) Functional Classification Class IV congestive heart failure
Have a history of ketoacidosis or hyperosmolar state or coma
Have a history of severe hypoglycemia or hypoglycemia unawareness within the 6 months.
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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 |
|---|---|---|---|---|---|---|
| Fiel Family and Sports Medicine PC | Tempe | Arizona | 85283 | United States | ||
| New Hope Research Development |
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| Label | URL |
|---|---|
| A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2) | 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 European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 5 Milligrams (mg) Tirzepatide | Participants received 5 mg tirzepatide subcutaneously (SC) administered once weekly (QW) for 12 weeks. |
| 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 | Aug 26, 2022 | Oct 22, 2024 |
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| Change From Baseline in Percentage of Time Per Day That CGM-derived Values Were >180 mg/dl (10 mmol/L) |
Change from Baseline in Percentage of Time per Day that CGM-derived Values were >180 mg/dl (10 mmol/L) was assessed. |
| Baseline, Week 12 |
| Change From Baseline in Duration of Time in Minutes Per Day That CGM Derived Values Were >180 mg/dl (10 mmol/L) | Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values were >180 mg/dl (10 mmol/L) was assessed. | Baseline, Week 4 |
| Change From Baseline in Duration of Time in Minutes Per Day That CGM Derived Values Were >180 mg/dl (10 mmol/L) | Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values were >180 mg/dl (10 mmol/L) was assessed. | Baseline, Week 12 |
| Change From Baseline in Fasting Serum Glucose (FSG) | Change from Baseline in FSG was assessed. | Baseline, Week 12 |
| Change From Baseline in Weight | Change from Baseline in Weight was assessed. | Baseline, Week 12 |
| Corona |
| California |
| 92882 |
| United States |
| Velocity Clinical Research, Gardena | Gardena | California | 90247 | United States |
| Velocity Clinical Research, Huntington Park | Huntington Park | California | 90255 | United States |
| Velocity Clinical Research, Huntington Park | Los Angeles | California | 90057 | United States |
| Valley Clinical Trials, Inc. | Northridge | California | 91325 | United States |
| Dream Team Clinical Research | Pomona | California | 91767 | United States |
| Scripps Whittier Diabetes Institute | San Diego | California | 92121-1520 | United States |
| Metabolic Institute of America | Tarzana | California | 91356-3551 | United States |
| CMR of Greater New Haven, LLC | Waterbury | Connecticut | 06708 | United States |
| Velocity Clinical Research, Hallandale Beach | Hallandale | Florida | 33009 | United States |
| East Coast Institute for Research, LLC | Jacksonville | Florida | 32204 | United States |
| Florida Institute For Clinical Research, LLC | Orlando | Florida | 32825 | United States |
| New Tampa Health | Tampa | Florida | 33603-3402 | United States |
| Georgia Clinical Research | Lawrenceville | Georgia | 30044-5896 | United States |
| Endocrine Research Solutions, Inc. | Roswell | Georgia | 30076 | United States |
| Velocity Clinical Research, Valparaiso | Valparaiso | Indiana | 46383 | United States |
| Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa | 50265 | United States |
| Cotton O'Neil Clinic | Topeka | Kansas | 66606 | United States |
| Versailles Family Medicine | Versailles | Kentucky | 40383-1947 | United States |
| Endocrine and Metabolic Consultants | Rockville | Maryland | 20852 | United States |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | United States |
| Clinical Research of South Nevada | Las Vegas | Nevada | 89121 | United States |
| Palm Research Center Tenaya | Las Vegas | Nevada | 89128 | United States |
| Advanced Medical Research | Maumee | Ohio | 43537-9402 | United States |
| Conrad Clinical Research | Edmond | Oklahoma | 73013 | United States |
| Mountain View Clinical Research, Inc. | Greenville | South Carolina | 29607 | United States |
| Texas Diabetes & Endocrinology, P.A. | Austin | Texas | 78731-4309 | United States |
| North Texas Endocrine Center | Dallas | Texas | 75231 | United States |
| Memorial City Endocrine Consultants | Houston | Texas | 77043-2742 | United States |
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | United States |
| ClinPoint Trials | Waxahachie | Texas | 75165 | United States |
| Received At Least 1 Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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All participants who received at least one dose of tirzepatide.
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| ID | Title | Description |
|---|---|---|
| BG000 | 5 mg Tirzepatide | Participants received 5 mg tirzepatide SC administered QW for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| Hemoglobin A1c (HbA1c) | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. | Mean | Standard Deviation | Percentage of HbA1c |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Hemoglobin A1c (HbA1c) | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. | All participants who received at least one dose of tirzepatide, had a baseline and had evaluable data for this outcome. | Posted | Least Squares Mean | Standard Error | Percentage of HbA1c | Baseline, Week 12 |
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| Secondary | Change From Baseline in Percentage of Time Per Day That Continuous Glucose Monitoring (CGM)-Derived Values Were >180 Milligram/Deciliter (mg/dl) (10 Millimole/Liter (mmol/L)) | Change from Baseline in Percentage of Time per Day that CGM-derived Values were >180 mg/dl (10 mmol/L) was assessed. | All participants who received at least one dose of tirzepatide, had a baseline and at least one post-baseline value for this outcome. | Posted | Least Squares Mean | Standard Error | Percentage of time per day | Baseline, Week 4 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Percentage of Time Per Day That CGM-derived Values Were >180 mg/dl (10 mmol/L) | Change from Baseline in Percentage of Time per Day that CGM-derived Values were >180 mg/dl (10 mmol/L) was assessed. | All participants who received at least one dose of tirzepatide, had a baseline and at least one post-baseline value for this outcome. | Posted | Least Squares Mean | Standard Error | Percentage of time per day | Baseline, Week 12 |
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| Secondary | Change From Baseline in Duration of Time in Minutes Per Day That CGM Derived Values Were >180 mg/dl (10 mmol/L) | Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values were >180 mg/dl (10 mmol/L) was assessed. | All participants who received at least one dose of tirzepatide, had a baseline and at least one post-baseline value for this outcome. | Posted | Least Squares Mean | Standard Error | Minutes per day | Baseline, Week 4 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Duration of Time in Minutes Per Day That CGM Derived Values Were >180 mg/dl (10 mmol/L) | Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values were >180 mg/dl (10 mmol/L) was assessed. | All participants who received at least one dose of tirzepatide, had a baseline and at least one post-baseline value for this outcome. | Posted | Least Squares Mean | Standard Error | Minutes per day | Baseline, Week 12 |
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| Secondary | Change From Baseline in Fasting Serum Glucose (FSG) | Change from Baseline in FSG was assessed. | All participants who received at least one dose of tirzepatide, had a baseline and at least one post-baseline value for this outcome. | Posted | Least Squares Mean | Standard Error | milligrams per deciliter (mg/dL) | Baseline, Week 12 |
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| Secondary | Change From Baseline in Weight | Change from Baseline in Weight was assessed. | All participants who received at least one dose of tirzepatide, had a baseline and at least one post-baseline value for this outcome. | Posted | Least Squares Mean | Standard Error | kilograms (kg) | Baseline, Week 12 |
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|
Baseline Up To 12 Weeks
All participants who received at least one dose of tirzepatide.
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| 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 SC administered QW for 12 weeks. | 0 | 152 | 1 | 152 | 0 | 152 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
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| 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 | Sep 19, 2023 | Oct 22, 2024 | SAP_001.pdf |
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| 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 |
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| 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 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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