A Study of LY2963016 Compared to LANTUS® in Adult Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY2963016; LANTUS®; Oral Antihyperglycemic Medication
Intervention description: Administered SC; Administered SC; Administered as per standard-of-care.
Intervention MeSH terms: Hypoglycemic Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 493.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the safety and efficacy of the study drug known
      as LY2963016 as compared to LANTUS® in adults with type 2 diabetes mellitus who are on 2 or
      more oral antihyperglycemic medications (OAMs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have type 2 diabetes mellitus (T2DM).

          -  Have been receiving 2 or more OAMs at stable doses for the 12 weeks prior to
             screening, with or without basal insulin.

          -  If currently on basal insulin, must be taking LANTUS® QD or NPH or insulin detemir
             either QD or twice a day for at least 90 days prior to study entry.

          -  Have an HbA1c ≥7.0% and ≤11.0% if insulin naïve; if previously on basal insulin, then
             HbA1c ≤11.0%.

          -  Body mass index (BMI) ≤45 kilograms per meter squared (kg/m^2).

          -  As determined by the investigator, are capable and willing to do the following:

               -  perform self monitored blood glucose (SMBG)

               -  complete participant diaries as instructed

               -  are receptive to diabetes education

               -  comply with required study treatment and study visits

        Exclusion Criteria:

          -  Have been on LANTUS® more than once daily within the previous 30 days.

          -  Have used any other insulin except the entry insulin [LANTUS®, insulin detemir, or
             NPH] including commercial (includes any premixed insulins) and investigational
             insulins within the previous 30 days.

          -  Have been exposed to a biosimilar insulin glargine within the previous 90 days.

          -  Have participated in a LY2963016 study.

          -  Have taken basal plus mealtime insulin (basal bolus therapy) within the last year for
             greater than 4 continuous weeks.

          -  Have used any glucagon like peptide (GLP-1) receptor agonists within the previous 90
             days.

          -  Have used pramlintide within the previous 30 days.

          -  Have excessive insulin resistance at study entry (total insulin dose ≥1.5 units/kg).

          -  Have more than 1 episode of severe hypoglycemia within 6 months prior to screening.

          -  Have had 2 or more emergency room visits or hospitalizations due to poor glucose
             control in the 6 months prior to screening.

          -  Have known hypersensitivity or allergy to LANTUS® or its excipients.

          -  Are receiving chronic (lasting longer than 14 consecutive days) systemic
             glucocorticoid therapy 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 (e.g., congestive
             heart failure Class III or IV) or gastrointestinal disease (e.g., significant
             gastroparesis).

          -  Have a history of renal transplantation or are currently receiving renal dialysis.

          -  Have a serum creatinine greater than 2.0 milligrams/deciliter (177 micromoles/liter).

          -  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 (with the exception of basal cell carcinoma or carcinoma in situ).

          -  Have a history or diagnosis of Human Immunodeficiency Virus (HIV) infection.

          -  Have any other condition (including known drug or alcohol abuse or psychiatric
             disorder including dementia) that precludes the participant from following and
             completing the protocol.

          -  Are pregnant or intend to become pregnant during the course of the study.

          -  Women who are breastfeeding.

          -  Are currently enrolled in, or discontinued within the last 30 days from, a clinical
             trial involving an investigational product or non-approved use of a drug or device
             other than LY2963016, or concurrently enrolled in any other type of medical research
             judged not to be scientifically or medically compatible with this study.