A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05706506
• Other study ID #: 18520
• Secondary ID: I8F-MC-GPIL2022-
• Status: Completed
• Phase: Phase 4
• Start date: March 8, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: January 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 a-glucosidase inhibitors.

Exclusion Criteria:

• Have Type 1 Diabetes (T1D)

• Have a clinical history of

• proliferative diabetic retinopathy

• diabetic maculopathy, or

• nonproliferative 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Tirzepatide
Administered SC

Locations

Country	Name	City	State
United States	Texas Diabetes & Endocrinology, P.A.	Austin	Texas
United States	Clinical Research Professionals	Chesterfield	Missouri
United States	New Hope Research Development	Corona	California
United States	North Texas Endocrine Center	Dallas	Texas
United States	Conrad Clinical Research	Edmond	Oklahoma
United States	Velocity Clinical Research, Gardena	Gardena	California
United States	Mountain View Clinical Research, Inc.	Greenville	South Carolina
United States	Velocity Clinical Research, Hallandale Beach	Hallandale Beach	Florida
United States	Memorial City Endocrine Consultants	Houston	Texas
United States	Velocity Clinical Research, Huntington Park	Huntington Park	California
United States	East Coast Institute for Research, LLC	Jacksonville	Florida
United States	Clinical Research of South Nevada	Las Vegas	Nevada
United States	Palm Research Center Tenaya	Las Vegas	Nevada
United States	Georgia Clinical Research	Lawrenceville	Georgia
United States	Velocity Clinical Research, Huntington Park	Los Angeles	California
United States	Advanced Medical Research	Maumee	Ohio
United States	Valley Clinical Trials, Inc.	Northridge	California
United States	Florida Institute For Clinical Research, LLC	Orlando	Florida
United States	Dream Team Clinical Research	Pomona	California
United States	Endocrine and Metabolic Consultants	Rockville	Maryland
United States	Endocrine Research Solutions, Inc.	Roswell	Georgia
United States	Scripps Whittier Diabetes Institute	San Diego	California
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	New Tampa Health	Tampa	Florida
United States	Metabolic Institute of America	Tarzana	California
United States	Fiel Family and Sports Medicine PC	Tempe	Arizona
United States	Cotton O'Neil Clinic	Topeka	Kansas
United States	Velocity Clinical Research, Valparaiso	Valparaiso	Indiana
United States	Versailles Family Medicine	Versailles	Kentucky
United States	CMR of Greater New Haven, LLC	Waterbury	Connecticut
United States	ClinPoint Trials	Waxahachie	Texas
United States	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Hemoglobin A1c (HbA1c)		Baseline, Week 12
Secondary	Change from Baseline in Percentage of Time per Day that Continuous Glucose Monitoring (CGM)-derived Values are >180 milligram/deciliter (mg/dl) 10 millimole/liter (mmol/L)		Baseline, Week 4
Secondary	Change from Baseline in Percentage of Time per Day that Continuous Glucose Monitoring (CGM)-derived Values are >180 mg/dl (10 mmol/L)		Baseline, Week 12
Secondary	Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values are >180 mg/dl (10 mmol/L)		Baseline, Week 4
Secondary	Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values are >180 mg/dl (10 mmol/L)		Baseline, Week 12
Secondary	Change from Baseline in Fasting Serum Glucose (FSG)		Baseline, Week 12
Secondary	Change from Baseline in Weight		Baseline, Week 12

External Links

•   A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2)