a study of ly2963016 compared to lantus® in adult participants with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

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.