A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY2189265; Sulfonylureas (SU); Biguanides (BG); alpha-glucosidase inhibitor (a-GI); Thiazolidinedione (TZD); Glinides
Intervention description: SU is a pre-study prescribed dose and is not being provided as part of the trial.; Biguanides is a pre-study prescribed dose and is not being provided as part of the trial.; a-GI is a pre-study prescribed dose and is not being provided as part of the trial.; TZD is a pre-study prescribed dose and is not being provided as part of the trial.; Glinides is a pre-study prescribed dose and is not being provided as part of the trial.
Intervention MeSH terms: Dulaglutide; Biguanides; 2,4-thiazolidinedione; Glycoside Hydrolase Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 394.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Type 2 diabetes mellitus; Oral antihyperglycemic medications; Long-Term Safety; GLP 1; Glucagon like peptide 1

Summary:

      This was a 52-week, multicenter, non-randomized, open-label, Phase 3 long-term safety study
      in participants with type 2 diabetes mellitus who have inadequate glycemic control with
      monotherapy of oral antihyperglycemic medication (OAM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have had a diagnosis of type 2 diabetes mellitus before screening

          -  Participants who have been taking SU (Glibenclamide, Gliclazide, Glimepiride), BG,
             TZD, a-GI or glinides monotherapy for at least 3 months before screening and have been
             on a stable dose for at least 8 weeks before screening

          -  Participants must have a qualifying HbA1c value of 7.0% to 11.0% at screening

          -  Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter
             squared (kg/m^2)

        Exclusion Criteria:

          -  Participants who have a diagnosis of type 1 diabetes

          -  Participants who have previously been treated with any other glucagon-like peptide-1
             (GLP-1) analog within the 3 months before screening

          -  Participants who are currently taking insulin or have had previous insulin treatment
             within the 3 months before screening

          -  Participants who have obvious clinical signs or symptoms of pancreatitis, a history of
             chronic pancreatitis, or acute pancreatitis at screening, as determined by the
             investigator. Participants who have a serum amylase concentration ≥3 times the upper
             limit of the reference range and/or a serum lipase concentration ≥2 times the upper
             limit of the reference range, as determined by the central laboratory at screening

          -  Participants who have self or family history of medullary C-cell hyperplasia, focal
             hyperplasia, or medullary thyroid carcinoma (MTC)