A Study of LY2963016 Compared to LANTUS® in Adult Participants With Type 2 Diabetes Mellitus (ELEMENT 5)

Lilly

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: LY2963016; Drug: LANTUS®; Drug: Oral Antihyperglycemic Medication

Study type: Interventional

Funder types: Industry

Identifiers

NCT02302716

I4L-MC-ABER (Other Identifier)

15615

Details and patient eligibility

About

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).

Enrollment: 493 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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493 participants in 2 patient groups

LY2963016

Experimental group

Description:

Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine hagedorn (NPH) QD will begin the study at their current dose SC. Participants will self titrate LY2963016 based on fasting blood glucose (FBG). Participants entering on insulin detemir or NPH twice a day will be started at 80% of the total daily dose SC. Participants will continue oral antihyperglycemic medication (OAM).

Treatment:

Drug: LY2963016

Drug: Oral Antihyperglycemic Medication

LANTUS®

Active Comparator group

Description:

Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD will be started at the same dose SC. Participants entering on insulin detemir or NPH twice a day will be started at 80% of the total daily dose SC. Participants will self titrate LANTUS® based on FBG. Participants will continue OAM.

Treatment:

Drug: LANTUS®

Drug: Oral Antihyperglycemic Medication