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

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Boehringer Ingelheim
• Treatments: Hypoglycemic Agents; Insulin; Insulin Glargine

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.