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

Part of paid clinical trials in Cooper City, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT05564039
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 30, 2022
Status verified
Jul 2025
Primary completion
Jul 15, 2024
Completion
Aug 12, 2024

Study Design

Enrollment
282 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 15 Milligram (mg) Tirzepatide or Maximum Tolerated Dose (MTD)
    Participants received tirzepatide administered as subcutaneous (SC) injection via a single-dose pen (SDP) once weekly (QW) for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5mg to 15 mg) until 15 mg or MTD was reached.
  • Active Comparator: 4.5 mg Dulaglutide or MTD
    Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached.

Primary Outcome Measure

Change From Baseline in HbA1c [ Time Frame: Baseline, Week 40 ]

Locations (11)

FacilityCityStateZIPSite coordinators
ALL Medical Research, LLCCooper CityFlorida33024-
Metabolic Research Institute, Inc.West Palm BeachFlorida33401-
NorthShore University Health SystemSkokieIllinois60077-
Iowa Diabetes and Endocrinology Research CenterWest Des MoinesIowa50265-
Clinvest Research LLCSpringfieldMissouri65807-
Alliance for Multispecialty Research, LLCNormanOklahoma73069-
Biopharma Informatic, LLCHoustonTexas77043-
Juno ResearchHoustonTexas77040-
Juno ResearchHoustonTexas77054-
Southern Endocrinology AssociatesMesquiteTexas75149-
North Hills Family Medicine/North Hills Medical ResearchNorth Richland HillsTexas76180-

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