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NCT05706506 | Completed | Type 2 Diabetes

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

Condition or disease

Type 2 Diabetes

Diabetes Mellitus, Type 2

Intervention/treatment

Tirzepatide

Phase

Phase 4

Study Type : Interventional
Estimated Enrollment : 152 participants
Masking : None (Open Label)
Primary Purpose : Treatment
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)
Actual Study Start Date : March 8, 2023
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : October 31, 2023
Arm Intervention/treatment

Experimental: Tirzepatide

Participants will receive tirzepatide subcutaneously (SC).

Drug: Tirzepatide
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2)

Location Details

Please Choose a site

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Arizona

Fiel Family and Sports Medicine PC

Tempe, Arizona, United States, 85283

Not yet recruiting

United States, California

New Hope Research Development

Corona, California, United States, 92882

Not yet recruiting

United States, California

Velocity Clinical Research, Gardena

Gardena, California, United States, 90247

Not yet recruiting

United States, California

Velocity Clinical Research, Huntington Park

Huntington Park, California, United States, 90255

Not yet recruiting

United States, California

Velocity Clinical Research, Huntington Park

The Angels, California, United States, 90057

Not yet recruiting

United States, California

Valley Clinical Trials, Inc.

Northridge, California, United States, 91325

Not yet recruiting

United States, California

Dream Team Clinical Research

Pomona, California, United States, 91767

Not yet recruiting

United States, California

Scripps Whittier Diabetes Institute

San Diego, California, United States, 92121-1520

Not yet recruiting

United States, California

Metabolic Institute of America

Tarzan, California, United States, 91356-3551

Not yet recruiting

United States, Connecticut

CMR of Greater New Haven, LLC

Waterbury, Connecticut, United States, 06708

Not yet recruiting

United States, Florida

Velocity Clinical Research, Hallandale Beach

Hallandale Beach, florida, United States, 33009

Not yet recruiting

United States, Florida

East Coast Institute for Research, LLC

Jacksonville, florida, United States, 32204

Not yet recruiting

United States, Florida

Florida Institute For Clinical Research, LLC

Orlando, florida, United States, 32825

Not yet recruiting

United States, Florida

New Tampa Health

Tampa, florida, United States, 33603-3402

Not yet recruiting

United States, Georgia

Georgia Clinical Research

Lawrenceville, Georgia, United States, 30044-5896

Not yet recruiting

United States, Georgia

Endocrine Research Solutions, Inc.

Roswell, Georgia, United States, 30076

Not yet recruiting

United States, Indiana

Velocity Clinical Research, Valparaiso

Valparaiso, Indiana, United States, 46383

Not yet recruiting

United States, Iowa

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States, 50265

Not yet recruiting

United States, Kansas

Cotton O'Neil Clinic

Topeka, Kansas, United States, 66606

Not yet recruiting

United States, Kentucky

Versailles Family Medicine

Versailles, Kentucky, United States, 40383-1947

Not yet recruiting

United States, Maryland

Endocrine and Metabolic Consultants

Rockville, Maryland, United States, 20852

Not yet recruiting

United States, Missouri

Clinical Research Professionals

Chesterfield, missouri, United States, 63005

Not yet recruiting

United States, Nevada

Clinical Research of South Nevada

Las Vegas, Nevada, United States, 89121

Not yet recruiting

United States, Nevada

Palm Research Center Tenaya

Las Vegas, Nevada, United States, 89128

Not yet recruiting

United States, Ohio

Advanced Medical Research

Maumee, Ohio, United States, 43537-9402

Not yet recruiting

United States, Oklahoma

Conrad Clinical Research

Edmond, Oklahoma, United States, 73013

Not yet recruiting

United States, South Carolina

Mountain View Clinical Research, Inc.

Greenville, South Carolina, United States, 29607

Not yet recruiting

United States, Texas

Texas Diabetes & Endocrinology, P.A.

Austin, Texas, United States, 78731-4309

Not yet recruiting

United States, Texas

North Texas Endocrine Center

dallas, Texas, United States, 75231

Not yet recruiting

United States, Texas

Memorial City Endocrine Consultants

Houston, Texas, United States, 77043-2742

Not yet recruiting

United States, Texas

Consano Clinical Research, LLC

Corpse Park, Texas, United States, 78231

Not yet recruiting

United States, Texas

ClinPoint Trials

Waxahachie, Texas, United States, 75165