A Study of Insulin Glargine (LY2963016) in Adult Participants With Type 2 Diabetes in India
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin Glargine
Intervention description: Administered SC
Intervention MeSH terms: Insulin Glargine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 304.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The reason for this study is to see if insulin glargine is safe in participants with type 2
      diabetes mellitus (T2DM) in India.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have T2DM based on the disease diagnostic criteria from the World Health Organization
             (WHO) classification for at least 6 months before screening.

          -  Have been receiving glucagon-like peptide-1 receptor agonist (GLP-1 RA) or ≥2 oral
             antihyperglycemic medication (OAMs) at stable doses for 90 days prior to screening.

          -  Have an HbA1c level ≥7.0% and <11.0%.

          -  Have never been treated with insulins except for short term treatment of acute
             conditions up to a maximum of 14 days.

        Exclusion Criteria:

          -  Have any form of diabetes other than T2DM.

          -  Have hypersensitivity to the active substance of LY2963016 or to any of the
             excipients.

          -  Have any clinically significant disorder, other than T2DM, that in the investigator's
             opinion, would preclude participation in the trial.

          -  Are receiving systemic glucocorticosteroids therapy or have excessive insulin
             resistance (total insulin dose >2 units per kilogram).

          -  Have a history or diagnosis of human immunodeficiency virus infection, hepatitis B and
             C.

          -  Have comorbidities of unstable angina, cardiac failure (Stage III or IV as per New
             York Heart Association guidelines) or renal failure (estimated glomerular filtration
             rate <30 milliliters/minute/meter squared).

          -  Are pregnant or intend to become pregnant during the course of the study; or are
             sexually active women of child-bearing potential not actively practicing birth control
             by a medically acceptable method as determined by the investigator.

          -  Is a woman who is breastfeeding.

          -  Have participated within the last 30 days in a clinical trial involving an
             investigational product other than the LY2963016. If the previous investigational
             product has a long half-life, 3 months or 5 half-lives (whichever is longer) should
             have passed.

          -  Have previously completed or withdrawn from this study or any other study
             investigating LY2963016. This exclusion criterion does not apply to participants who
             are rescreened prior to baseline visit.

          -  Are currently enrolled in any other clinical study involving an investigational
             product or any other type of medical research judged not to be scientifically or
             medically compatible with this study.

          -  Are unwilling or unable to comply with the use of a glucometer.