A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2)
An Open-Label, Single-Arm, Phase 4 Study to Assess Glycemic Control When Adults With Type 2 Diabetes Switch From a GLP-1 RA to Tirzepatide (SURPASS-SWITCH-2)
3 other identifiers
interventional
152
1 country
32
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 type-2-diabetes
Started Mar 2023
Shorter than P25 for phase_4 type-2-diabetes
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2023
CompletedFirst Posted
Study publicly available on registry
January 31, 2023
CompletedStudy Start
First participant enrolled
March 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedResults Posted
Study results publicly available
December 13, 2024
CompletedDecember 13, 2024
December 1, 2024
8 months
January 23, 2023
October 30, 2024
December 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
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))
Baseline, Week 4
Change From Baseline in Percentage of Time Per Day That CGM-derived Values Were >180 mg/dl (10 mmol/L)
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)
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)
Baseline, Week 12
Change From Baseline in Fasting Serum Glucose (FSG)
Baseline, Week 12
- +1 more secondary outcomes
Study Arms (1)
5 milligrams (mg) Tirzepatide
EXPERIMENTALParticipants received 5 mg tirzepatide subcutaneously administered once weekly for 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Have Type 2 diabetes (T2D)
- 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.
You may not qualify if:
- Have Type 1 Diabetes (T1D)
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Fiel Family and Sports Medicine PC
Tempe, Arizona, 85283, United States
New Hope Research Development
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2023
First Posted
January 31, 2023
Study Start
March 8, 2023
Primary Completion
October 31, 2023
Study Completion
October 31, 2023
Last Updated
December 13, 2024
Results First Posted
December 13, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.