A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Oral antihyperglycemic medication (OAM)
Intervention description: Administered SC; Oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
Intervention MeSH terms: Tirzepatide; Hypoglycemic Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 443.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the long-term safety of the study drug tirzepatide
      in combination with oral antihyperglycemic medications in participants with type 2 diabetes.
    

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 ≥7.0% to <11.0%, as determined by the central laboratory at screening.

          -  Have been taking sulfonylureas, biguanides, thiazolidinedione, alpha-glucosidase
             inhibitor, glinides, or sodium-glucose cotransporter type 2 inhibitor monotherapy for
             at least 3 months before screening and have been on the following dose for at least 8
             weeks before screening.

          -  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.