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

Primary Purpose

Type 2 Diabetes, Diabetes Mellitus, Type 2

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tirzepatide
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 α-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.

Sites / Locations

  • Fiel Family and Sports Medicine PC
  • Family Care Associates
  • New Hope Research Development
  • Velocity Clinical Research, Gardena
  • Velocity Clinical Research, Huntington Park
  • Velocity Clinical Research, Huntington Park
  • Valley Clinical Trials, Inc.
  • Dream Team Clinical Research
  • Scripps Whittier Diabetes Institute
  • Metabolic Institute of America
  • CMR of Greater New Haven, LLC
  • Velocity Clinical Research, Hallandale Beach
  • East Coast Institute for Research, LLC
  • Florida Institute For Clinical Research, LLC
  • New Tampa Health
  • Georgia Clinical Research
  • Endocrine Research Solutions, Inc.
  • Velocity Clinical Research, Valparaiso
  • Iowa Diabetes and Endocrinology Research Center
  • Cotton O'Neil Clinic
  • Versailles Family Medicine
  • Endocrine and Metabolic Consultants
  • Clinical Research Professionals
  • Clinical Research of South Nevada
  • Palm Research Center Tenaya
  • Advanced Medical Research
  • Conrad Clinical Research
  • Oregon Health and Science University
  • Thomas Jefferson University
  • Mountain View Clinical Research, Inc.
  • Texas Diabetes & Endocrinology, P.A.
  • North Texas Endocrine Center
  • Memorial City Endocrine Consultants
  • Consano Clinical Research, LLC
  • ClinPoint Trials

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tirzepatide

Arm Description

Participants will receive tirzepatide subcutaneously (SC).

Outcomes

Primary Outcome Measures

Change from Baseline in Hemoglobin A1c (HbA1c)

Secondary Outcome Measures

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)
Change from Baseline in Percentage of Time per Day that Continuous Glucose Monitoring (CGM)-derived Values are >180 mg/dl (10 mmol/L)
Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values are >180 mg/dl (10 mmol/L)
Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values are >180 mg/dl (10 mmol/L)
Change from Baseline in Fasting Serum Glucose (FSG)
Change from Baseline in Weight

Full Information

First Posted
January 23, 2023
Last Updated
September 14, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05706506
Brief Title
A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 8, 2023 (Actual)
Primary Completion Date
November 2, 2023 (Anticipated)
Study Completion Date
November 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tirzepatide
Arm Type
Experimental
Arm Description
Participants will receive tirzepatide subcutaneously (SC).
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
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)
Time Frame
Baseline, Week 4
Title
Change from Baseline in Percentage of Time per Day that Continuous Glucose Monitoring (CGM)-derived Values are >180 mg/dl (10 mmol/L)
Time Frame
Baseline, Week 12
Title
Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values are >180 mg/dl (10 mmol/L)
Time Frame
Baseline, Week 4
Title
Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values are >180 mg/dl (10 mmol/L)
Time Frame
Baseline, Week 12
Title
Change from Baseline in Fasting Serum Glucose (FSG)
Time Frame
Baseline, Week 12
Title
Change from Baseline in Weight
Time Frame
Baseline, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 α-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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Fiel Family and Sports Medicine PC
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Family Care Associates
City
Burlingame
State/Province
California
ZIP/Postal Code
94010-3200
Country
United States
Facility Name
New Hope Research Development
City
Corona
State/Province
California
ZIP/Postal Code
92882
Country
United States
Facility Name
Velocity Clinical Research, Gardena
City
Gardena
State/Province
California
ZIP/Postal Code
90247
Country
United States
Facility Name
Velocity Clinical Research, Huntington Park
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Velocity Clinical Research, Huntington Park
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Valley Clinical Trials, Inc.
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Dream Team Clinical Research
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Scripps Whittier Diabetes Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92121-1520
Country
United States
Facility Name
Metabolic Institute of America
City
Tarzana
State/Province
California
ZIP/Postal Code
91356-3551
Country
United States
Facility Name
CMR of Greater New Haven, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Velocity Clinical Research, Hallandale Beach
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
East Coast Institute for Research, LLC
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Florida Institute For Clinical Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Facility Name
New Tampa Health
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603-3402
Country
United States
Facility Name
Georgia Clinical Research
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30044-5896
Country
United States
Facility Name
Endocrine Research Solutions, Inc.
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Velocity Clinical Research, Valparaiso
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
Iowa Diabetes and Endocrinology Research Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Cotton O'Neil Clinic
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Versailles Family Medicine
City
Versailles
State/Province
Kentucky
ZIP/Postal Code
40383-1947
Country
United States
Facility Name
Endocrine and Metabolic Consultants
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Clinical Research Professionals
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Facility Name
Clinical Research of South Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Facility Name
Palm Research Center Tenaya
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Advanced Medical Research
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537-9402
Country
United States
Facility Name
Conrad Clinical Research
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Mountain View Clinical Research, Inc.
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Texas Diabetes & Endocrinology, P.A.
City
Austin
State/Province
Texas
ZIP/Postal Code
78731-4309
Country
United States
Facility Name
North Texas Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Memorial City Endocrine Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77043-2742
Country
United States
Facility Name
Consano Clinical Research, LLC
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Facility Name
ClinPoint Trials
City
Waxahachie
State/Province
Texas
ZIP/Postal Code
75165
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org
Links:
URL
https://trials.lilly.com/en-US/trial/385077
Description
A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2)

Learn more about this trial

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

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