A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Semaglutide
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Tirzepatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1879.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: T2DM; GLP-1 RA; Glucose-dependent insulinotropic polypeptide (GIP); glucagon-like peptide-1 (GLP-1); GIP/GLP-1 dual receptor agonist

Summary:

      The reason for this study is to compare the effect of the study drug tirzepatide to
      semaglutide on blood sugar levels in participants with type 2 diabetes. The study will last
      approximately 47 weeks and may include about 12 visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have been diagnosed with type 2 diabetes mellitus (T2DM)

          -  Have HbA1c between ≥7.0% and ≤10.5%

          -  Be on stable treatment with unchanged dose of metformin >1500 mg/day for at least 3
             months prior to screening

          -  Be of stable weight (±5%) for at least 3 months before screening

          -  Have a body mass index (BMI) ≥25 kilograms per meter squared (kg/m²) at screening

        Exclusion Criteria:

          -  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 acute 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 an estimated glomerular filtration rate <45 milliliters/minute/1.73 m² (or lower
             than the country specific threshold for using the protocol required dose of metformin
             per local label)

          -  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 during the last 3
             months

          -  Have been taking weight loss drugs, including over-the-counter medications during the
             last 3 months