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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 (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05706506
Collaborator
(none)
150
Enrollment
1
Arm
8
Anticipated Duration (Months)

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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)
Anticipated Study Start Date :
Feb 8, 2023
Anticipated Primary Completion Date :
Oct 9, 2023
Anticipated Study Completion Date :
Oct 9, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tirzepatide

Participants will receive tirzepatide subcutaneously (SC).

Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in Hemoglobin A1c (HbA1c) [Baseline, Week 12]

    Secondary Outcome Measures

    1. 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]

    2. 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]

    3. 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]

    4. 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]

    5. Change from Baseline in Fasting Serum Glucose (FSG) [Baseline, Week 12]

    6. Change from Baseline in Weight [Baseline, Week 12]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: 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), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05706506
    Other Study ID Numbers:
    • 18520
    • I8F-MC-GPIL
    • 2022-002708-18
    First Posted:
    Jan 31, 2023
    Last Update Posted:
    Feb 8, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Tirzepatide

    Study Results

    No Results Posted as of Feb 8, 2023