A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Insulin Degludec
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: 1444.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: T2DM

Summary:

      The purpose of this study is to compare the effect of the study drug tirzepatide to insulin
      degludec on blood sugar levels in participants with type 2 diabetes. The study will last
      about 67 weeks and may include up to 22 visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must:

               -  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 or metformin plus an
                  SGLT-2 inhibitor for at least 3 months before screening

               -  Be of stable weight (± 5%) for at least 3 months before screening

               -  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 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 their ALT level is ≤3.0 the ULN for the
                  reference range

               -  Have an estimated glomerular filtration rate <45 mL/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, or metformin
                  plus an SGLT-2 inhibitor during the last 3 months

               -  Have been taking weight loss drugs, including over-the-counter medications during
                  the last 3 months