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

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-08

Study Completion Date

2023-10-31

Brief Summary

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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

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Conditions

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Type 2 Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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5 milligrams (mg) Tirzepatide

Participants received 5 mg tirzepatide subcutaneously administered once weekly for 12 weeks.

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Administered SC

Interventions

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Tirzepatide

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY3298176

Eligibility Criteria

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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
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

New Hope Research Development

Corona, California, United States

Site Status

Velocity Clinical Research, Gardena

Gardena, California, United States

Site Status

Velocity Clinical Research, Huntington Park

Huntington Park, California, United States

Site Status

Velocity Clinical Research, Huntington Park

Los Angeles, California, United States

Site Status

Valley Clinical Trials, Inc.

Northridge, California, United States

Site Status

Dream Team Clinical Research

Pomona, California, United States

Site Status

Scripps Whittier Diabetes Institute

San Diego, California, United States

Site Status

Metabolic Institute of America

Tarzana, California, United States

Site Status

CMR of Greater New Haven, LLC

Waterbury, Connecticut, United States

Site Status

Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, United States

Site Status

East Coast Institute for Research, LLC

Jacksonville, Florida, United States

Site Status

Florida Institute For Clinical Research, LLC

Orlando, Florida, United States

Site Status

New Tampa Health

Tampa, Florida, United States

Site Status

Georgia Clinical Research

Lawrenceville, Georgia, United States

Site Status

Endocrine Research Solutions, Inc.

Roswell, Georgia, United States

Site Status

Velocity Clinical Research, Valparaiso

Valparaiso, Indiana, United States

Site Status

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

Site Status

Cotton O'Neil Clinic

Topeka, Kansas, United States

Site Status

Versailles Family Medicine

Versailles, Kentucky, United States

Site Status

Endocrine and Metabolic Consultants

Rockville, Maryland, United States

Site Status

Clinical Research Professionals

Chesterfield, Missouri, United States

Site Status

Clinical Research of South Nevada

Las Vegas, Nevada, United States

Site Status

Palm Research Center Tenaya

Las Vegas, Nevada, United States

Site Status

Advanced Medical Research

Maumee, Ohio, United States

Site Status

Conrad Clinical Research

Edmond, Oklahoma, United States

Site Status

Mountain View Clinical Research, Inc.

Greenville, South Carolina, United States

Site Status

Texas Diabetes & Endocrinology, P.A.

Austin, Texas, United States

Site Status

North Texas Endocrine Center

Dallas, Texas, United States

Site Status

Memorial City Endocrine Consultants

Houston, Texas, United States

Site Status

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Site Status

ClinPoint Trials

Waxahachie, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://trials.lilly.com/en-US/trial/385077

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