A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Insulin Glargine
Intervention description: Administered SC.; Administered SC
Intervention MeSH terms: Insulin Glargine; Tirzepatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2002.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GIP; GLP-1; glucose metabolism disorders; metabolic diseases; endocrine system diseases; cardiovascular risk

Summary:

      The purpose of the trial is to assess the efficacy and safety of tirzepatide taken once a
      week to insulin glargine taken once daily in participants with type 2 diabetes and increased
      cardiovascular risk. The study will last about 108 weeks and may include up to 30 visits.
    

Eligibility criteria:

        Inclusion Criteria:

        Participants must:

          -  Have been diagnosed with type 2 diabetes mellitus (T2DM)

          -  Have HbA1c between ≥7.5% and ≤10.5%

          -  Be on stable treatment with unchanged dose of at least 1 and no more than 3 types of
             oral antihyperglycemic drugs, which may only include metformin, SGLT-2 inhibitors,
             and/or sulfonylureas for at least 3 months before screening

          -  Have increased risk for cardiovascular (CV) events

          -  Be of stable weight (± 5%)

          -  Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening

        Exclusion Criteria

        Participants must not:

          -  Have type 1 diabetes mellitus

          -  Have had chronic or acute pancreatitis any time prior to study entry

          -  Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative
             diabetic retinopathy requiring immediate or urgent treatment

          -  Have disorders associated with slowed emptying of the stomach, or have had any stomach
             surgeries for the purpose of weight loss

          -  Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or
             blood alanine transaminase (ALT) enzyme level >3.0 times the upper limit of normal
             (ULN) for the reference range, as determined by the central laboratory. Participants
             with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this
             trial only if there ALT level is ≤3.0 the ULN for the reference range

          -  Have had a heart attack, stroke, or hospitalization for congestive heart failure in
             the past 2 months

          -  Have a personal or family history of medullary thyroid carcinoma or personal history
             of multiple endocrine neoplasia syndrome type 2

          -  Have been taking any other diabetes medicines other than metformin, SGLT-2 inhibitors,
             and/or sulfonylureas during the last 3 months

          -  Have been taking weight loss drugs, including over-the-counter medications during the
             last 3 months