A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2)
NCT ID: NCT05706506
Last Updated: 2024-12-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
152 participants
INTERVENTIONAL
2023-03-08
2023-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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5 milligrams (mg) Tirzepatide
Participants received 5 mg tirzepatide subcutaneously administered once weekly for 12 weeks.
Tirzepatide
Administered SC
Interventions
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Tirzepatide
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have an HbA1c c ≥6.5% (≥48 mmol/mol) to ≤9.0% (≤75 mmol/mol)
* Have a body mass index (BMI) ≥25 kilogram per square meter (kg/m²) at screening
* Have been on a stable treatment dose of 1 of the listed GLP-1 RAs for ≥3 months
* No treatment with oral antidiabetic medicine (OAM) or on stable doses (for at least 3 months before screening) of up to 3 OAM. The OAM may include metformin, sodium-glucose linked transporter-2 inhibitor (SGLT-2i), thiazolidinediones, or α-glucosidase inhibitors.
Exclusion Criteria
* Have a clinical history of
* proliferative diabetic retinopathy
* diabetic maculopathy, or
* non-proliferative diabetic retinopathy that requires acute treatment
* Are at high risk for cardiovascular disease or have a history of
* myocardial infarction
* percutaneous coronary revascularization procedure
* carotid stenting or surgical revascularization
* nontraumatic amputation
* peripheral vascular procedure
* cerebrovascular accident
* or hospitalization for congestive heart failure
* 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Fiel Family and Sports Medicine PC
Tempe, Arizona, United States
New Hope Research Development
Corona, California, United States
Velocity Clinical Research, Gardena
Gardena, California, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, United States
Velocity Clinical Research, Huntington Park
Los Angeles, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Dream Team Clinical Research
Pomona, California, United States
Scripps Whittier Diabetes Institute
San Diego, California, United States
Metabolic Institute of America
Tarzana, California, United States
CMR of Greater New Haven, LLC
Waterbury, Connecticut, United States
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, United States
Florida Institute For Clinical Research, LLC
Orlando, Florida, United States
New Tampa Health
Tampa, Florida, United States
Georgia Clinical Research
Lawrenceville, Georgia, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States
Velocity Clinical Research, Valparaiso
Valparaiso, Indiana, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Cotton O'Neil Clinic
Topeka, Kansas, United States
Versailles Family Medicine
Versailles, Kentucky, United States
Endocrine and Metabolic Consultants
Rockville, Maryland, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Clinical Research of South Nevada
Las Vegas, Nevada, United States
Palm Research Center Tenaya
Las Vegas, Nevada, United States
Advanced Medical Research
Maumee, Ohio, United States
Conrad Clinical Research
Edmond, Oklahoma, United States
Mountain View Clinical Research, Inc.
Greenville, South Carolina, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, United States
North Texas Endocrine Center
Dallas, Texas, United States
Memorial City Endocrine Consultants
Houston, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
ClinPoint Trials
Waxahachie, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2)
Other Identifiers
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I8F-MC-GPIL
Identifier Type: OTHER
Identifier Source: secondary_id
2022-002708-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
18520
Identifier Type: -
Identifier Source: org_study_id