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A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH) (SURPASS-SWITCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05564039
Recruitment Status : Recruiting
First Posted : October 3, 2022
Last Update Posted : May 15, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to investigate the efficacy and safety of switching from weekly dulaglutide to weekly tirzepatide compared to increasing the dulaglutide dose in adults with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Tirzepatide Drug: Dulaglutide Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 4, Randomized, Open-Label, Active-Controlled Study to Investigate the Efficacy and Safety of Switching From Weekly Dulaglutide to Weekly Tirzepatide in Adults With Type 2 Diabetes
Actual Study Start Date : November 30, 2022
Estimated Primary Completion Date : June 6, 2024
Estimated Study Completion Date : July 4, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tirzepatide
Participants will receive tirzepatide subcutaneously (SC)
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Active Comparator: Dulaglutide
Participants will escalate their dulaglutide dose SC.
Drug: Dulaglutide
Administered SC
Other Name: LY2189265




Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 40 ]

Secondary Outcome Measures :
  1. Change from Baseline in Weight [ Time Frame: Baseline, Week 40 ]
  2. Percentage of Participants Who Achieve HbA1c <7% [ Time Frame: Baseline to Week 40 ]
  3. Percentage of Participants Who Achieve HbA1c ≤6.5% [ Time Frame: Baseline to Week 40 ]
  4. Percentage of Participants Who Achieve HbA1c <5.7% [ Time Frame: Baseline to Week 40 ]
  5. Percentage of Participants Who Achieve Weight loss from Baseline of ≥5% [ Time Frame: Baseline to Week 40 ]
  6. Percentage of Participants Who Achieve Weight loss from baseline of ≥10% [ Time Frame: Baseline to Week 40 ]
  7. Percentage of Participants Who Achieve Weight loss from baseline of ≥15% [ Time Frame: Baseline to Week 40 ]
  8. A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia [ Time Frame: Week 40 ]
    A composite endpoint defined as HbA1c ≤ 6.5%, weight loss ≥10%, no hypoglycemia, defined as blood glucose (BG) <54 milligram/deciliter (mg/dL) <3.0 millimole/liter (mmol/L) and/or severe hypoglycemia

  9. Change from Baseline in Fasting Serum Glucose (FSG) [ Time Frame: Baseline, Week 40 ]
  10. Change from Baseline in Waist Circumference [ Time Frame: Baseline, Week 40 ]
  11. Change from Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 40 ]
  12. Change from Baseline in Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite CT) - Physical Functioning Score [ Time Frame: Baseline, Week 40 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have type 2 diabetes
  • Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤9.5% (≤80 mmol/mol)
  • Are currently on a stable dose of dulaglutide weekly (0.75 mg or 1.5 mg) for at least 6 months prior to screening.
  • No treatment with oral antihyperglycemic medication (OAM), or on a stable dose of up to 3 OAMs, which may include metformin, sodium glucose cotransporter-2 inhibitors (SGLT-2i), and/or sulfonylurea, for at least 3 months before screening.
  • Have had stable body weight (±5%) during the 90 days preceding screening
  • Have BMI ≥25 kilogram/square meter (kg/m²)

Exclusion Criteria:

  • Have type 1 diabetes
  • Have a history of chronic or acute pancreatitis
  • Have a history of

    • proliferative diabetic retinopathy, or
    • diabetic maculopathy, or
    • nonproliferative diabetic retinopathy that requires acute treatment.
  • Have any of these cardiovascular (CV) conditions within 60 days prior to screening:

    • acute myocardial infarction,
    • cerebrovascular accident (stroke), or
    • hospitalization due to congestive heart failure (CHF).
  • Have New York Heart Assocation (NYHA) Functional Classification Class IV CHF
  • Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
  • Have within 90 days prior to screening received treatment with medications intended to promote weight loss. This includes prescribed, over-the-counter, or alternative remedies
  • Have an estimated glomerular filtration rate (eGFR) <30 mL/minute/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label)
  • Have been treated with insulin prior to screening

    • Exception: use of insulin for gestational diabetes or short-term use (<14 days) for acute conditions such as acute illness, hospitalization, or elective surgery.
  • Have a history of reduction of dose of dulaglutide, due to intolerability, without successful reescalation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05564039


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
Show Show 44 study locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05564039    
Other Study ID Numbers: 18395
I8F-MC-GPIH ( Other Identifier: Eli Lilly and Company )
2022-500101-41-00 ( Other Identifier: EU Trial Number )
First Posted: October 3, 2022    Key Record Dates
Last Update Posted: May 15, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tirzepatide
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dulaglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists