Clinical trial NCT05706506: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-01-31
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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
  * 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.

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: 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))
timeFrame: Baseline, Week 4
measure: Change From Baseline in Percentage of Time Per Day That CGM-derived Values Were >180 mg/dl (10 mmol/L)
timeFrame: Baseline, Week 12
measure: Change From Baseline in Duration of Time in Minutes Per Day That CGM Derived Values Were >180 mg/dl (10 mmol/L)
timeFrame: Baseline, Week 4
measure: Change From Baseline in Duration of Time in Minutes Per Day That CGM Derived Values Were >180 mg/dl (10 mmol/L)
timeFrame: Baseline, Week 12
measure: Change From Baseline in Fasting Serum Glucose (FSG)
timeFrame: Baseline, Week 12
measure: Change From Baseline in Weight
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Fiel Family and Sports Medicine PC
state: Arizona
city: Corona
country: United States
facility: New Hope Research Development
state: California
city: Gardena
country: United States
facility: Velocity Clinical Research, Gardena
state: California
city: Huntington Park
country: United States
facility: Velocity Clinical Research, Huntington Park
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research, Huntington Park
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Pomona
country: United States
facility: Dream Team Clinical Research
state: California
city: San Diego
country: United States
facility: Scripps Whittier Diabetes Institute
state: California
city: Tarzana
country: United States
facility: Metabolic Institute of America
state: California
city: Waterbury
country: United States
facility: CMR of Greater New Haven, LLC
state: Connecticut
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research, Hallandale Beach
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Orlando
country: United States
facility: Florida Institute For Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: New Tampa Health
state: Florida
city: Lawrenceville
country: United States
facility: Georgia Clinical Research
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions, Inc.
state: Georgia
city: Valparaiso
country: United States
facility: Velocity Clinical Research, Valparaiso
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Clinic
state: Kansas
city: Versailles
country: United States
facility: Versailles Family Medicine
state: Kentucky
city: Rockville
country: United States
facility: Endocrine and Metabolic Consultants
state: Maryland
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Las Vegas
country: United States
facility: Clinical Research of South Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Palm Research Center Tenaya
state: Nevada
city: Maumee
country: United States
facility: Advanced Medical Research
state: Ohio
city: Edmond
country: United States
facility: Conrad Clinical Research
state: Oklahoma
city: Greenville
country: United States
facility: Mountain View Clinical Research, Inc.
state: South Carolina
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: Dallas
country: United States
facility: North Texas Endocrine Center
state: Texas
city: Houston
country: United States
facility: Memorial City Endocrine Consultants
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Waxahachie
country: United States
facility: ClinPoint Trials
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: