A Study of Tirzepatide (LY3298176) Compared to Dulaglutide in Participants With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Dulaglutide
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Dulaglutide; Tirzepatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 636.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The reason for this study is to see if the study drug tirzepatide (LY3298176) is effective
      and safe compared to dulaglutide in participants with type 2 diabetes in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

        Participant must:

          -  Have been diagnosed with type 2 diabetes mellitus based on the World Health
             Organization classification before the screening visit.

          -  Have HbA1c meeting the following criteria, as determined by the central laboratory at
             screening and baseline:

               -  for participants who are oral antihyperglycemic medication (OAM)-naïve at
                  screening, ≥7.0% to ≤10.0% at both screening and baseline.

               -  for participants who have been taking OAM monotherapy at screening, ≥6.5% to
                  ≤9.0% at screening, and ≥7.0% to ≤10.0% at baseline.

          -  Have body mass index (BMI) of ≥23 kilograms per meter squared at screening.

          -  Be of stable weight (±5%) during 3 months preceding screening; and agree to not
             initiate an intensive diet and/or exercise program during the study with the intent of
             reducing body weight other than the lifestyle and dietary measures for diabetes
             treatment.

        Exclusion Criteria:

        Participant 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 weight loss drugs, including over-the-counter medications during the
             last 3 months.