A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY2963016; Lantus®
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin Glargine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 536.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Insulin glargine

Summary:

      The purpose of this study is to compare long-acting basal insulin analog LY2963016 to Lantus®
      in insulin naïve adult Chinese participants with Type 2 Diabetes Mellitus (T2DM) on 2 or more
      oral antihyperglycemic medications (OAMs). Participants will continue their OAMs throughout
      the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have T2DM based on the disease diagnostic criteria World Health Organization (WHO)
             classification.

          -  Have been receiving 2 or more OAMs at stable doses for the 12 weeks prior to
             screening.

          -  Have a HbA1c ≥7.0% and ≤11.0%.

          -  Body mass index (BMI) ≤35 kilograms per meter squared.

        Exclusion Criteria:

          -  Have used insulin therapy (outside of pregnancy) anytime in the past 1 year, except
             for short-term treatment of acute conditions, and up to a maximum of 4 continuous
             weeks.

          -  Have used any glucagon like peptide (GLP-1) receptor agonists within the previous 90
             days.

          -  Are currently taking traditional medicine (herbal medicine or patent medicine) with
             known/specified content of anti-hyperglycemic effects within 3 months before
             screening.

          -  Have had more than one episode of severe hypoglycemia within 6 months prior to entry
             into the study.

          -  Have had ≥2 emergency room visits or hospitalizations due to poor glucose control.

          -  Have known hypersensitivity or allergy to Lantus® or its excipients.

          -  Are receiving chronic systemic glucocorticoid therapy at pharmacological doses or have
             received such therapy within 4 weeks immediately preceding screening.

          -  Have obvious signs or symptoms, or laboratory evidence, of liver disease.

          -  Have one of the following concomitant diseases: significant cardiac or
             gastrointestinal disease.

          -  Have a history of renal transplantation, are currently receiving renal dialysis or
             have a serum creatinine greater than 2.0 milligrams per deciliter.

          -  Have had a blood transfusion or severe blood loss within 3 months prior to screening
             or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia.

          -  Participants with active cancer or personal history of cancer within the previous 5
             years.

          -  Are pregnant or intend to become pregnant during the course of the study.

          -  Are women who are breastfeeding.