A Study of LY2963016 Compared to LANTUS® in Adult Participants With Type 2 Diabetes Mellitus

A Prospective, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog LY2963016 to LANTUS® in Adult Patients With Type 2 Diabetes Mellitus: The ELEMENT 5 Study

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).

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.