A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2)
- Registration Number
- NCT05706506
- Lead Sponsor
- Eli Lilly and Company
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 152
- 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.
-
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
-
Have a history of severe hypoglycemia or hypoglycemia unawareness within the 6 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 5 milligrams (mg) Tirzepatide Tirzepatide Participants received 5 mg tirzepatide subcutaneously administered once weekly for 12 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 12 HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
- Secondary Outcome Measures
Name Time Method 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) was assessed.
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 Percentage of Time per Day that CGM-derived Values were \>180 mg/dl (10 mmol/L) was assessed.
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 Duration of Time in Minutes per Day that CGM derived Values were \>180 mg/dl (10 mmol/L) was assessed.
Change From Baseline in Fasting Serum Glucose (FSG) Baseline, Week 12 Change from Baseline in FSG was assessed.
Change From Baseline in Weight Baseline, Week 12 Change from Baseline in Weight was assessed.
Trial Locations
- Locations (31)
Velocity Clinical Research, Huntington Park
🇺🇸Los Angeles, California, United States
Versailles Family Medicine
🇺🇸Versailles, Kentucky, United States
Texas Diabetes & Endocrinology, P.A.
🇺🇸Austin, Texas, United States
Advanced Medical Research
🇺🇸Maumee, Ohio, United States
Dream Team Clinical Research
🇺🇸Pomona, California, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
North Texas Endocrine Center
🇺🇸Dallas, Texas, United States
Memorial City Endocrine Consultants
🇺🇸Houston, Texas, United States
Iowa Diabetes and Endocrinology Research Center
🇺🇸West Des Moines, Iowa, United States
Metabolic Institute of America
🇺🇸Tarzana, California, United States
Mountain View Clinical Research, Inc.
🇺🇸Greenville, South Carolina, United States
Endocrine and Metabolic Consultants
🇺🇸Rockville, Maryland, United States
Conrad Clinical Research
🇺🇸Edmond, Oklahoma, United States
Clinical Research Professionals
🇺🇸Chesterfield, Missouri, United States
Endocrine Research Solutions, Inc.
🇺🇸Roswell, Georgia, United States
Scripps Whittier Diabetes Institute
🇺🇸San Diego, California, United States
Clinical Research of South Nevada
🇺🇸Las Vegas, Nevada, United States
Palm Research Center Tenaya
🇺🇸Las Vegas, Nevada, United States
New Hope Research Development
🇺🇸Corona, California, United States
Fiel Family and Sports Medicine PC
🇺🇸Tempe, Arizona, United States
Velocity Clinical Research, Gardena
🇺🇸Gardena, California, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
CMR of Greater New Haven, LLC
🇺🇸Waterbury, Connecticut, United States
East Coast Institute for Research, LLC
🇺🇸Jacksonville, Florida, United States
Velocity Clinical Research, Hallandale Beach
🇺🇸Hallandale Beach, Florida, United States
Georgia Clinical Research
🇺🇸Lawrenceville, Georgia, United States
Cotton O'Neil Clinic
🇺🇸Topeka, Kansas, United States
ClinPoint Trials
🇺🇸Waxahachie, Texas, United States
Florida Institute For Clinical Research, LLC
🇺🇸Orlando, Florida, United States
New Tampa Health
🇺🇸Tampa, Florida, United States
Velocity Clinical Research, Valparaiso
🇺🇸Valparaiso, Indiana, United States