A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India

A 26- Week, Multicenter, Open-Label, Single-Arm, Phase 4 Study to Assess The Safety of Lyumjev in Adult Patients With Type 2 Diabetes Mellitus in India

The purpose of this study is to assess the safety of insulin lispro-aabc in adult participants with Type 2 diabetes mellitus in India.

The study will last about 33 weeks for each participant, including screening (1 week), Lead-in period (4 weeks), treatment period (26 weeks) and follow up period (2 weeks).

Inclusion Criteria:

• Have Type 2 Diabetes Mellitus (T2DM) for ≥1 year prior to screening

• Treated for ≥90 days prior to screening with multiple daily injection (MDI) therapy

  • on basal insulin or insulin glargine 100 U/mL [Basaglar or Lantus] or insulin glargin 300 U/mL, insulin determir, insulin degludec U-100, or neutral protamine Hagedorn (NPH) insulin) in combination with at least 1 prandial injection of bolus insulin (insulin lispro 100 U/mL or 200 U/mL, insulin aspart, insulin glulisine, regular insulin, fast-acting insulin aspart), or
  • premixed analog or human insulin regimens with any basal and bolus insulin

• May have been treated with up to 3 oral antihyperglycemic medications (OAMs) including metformin, sodium-glucose cotransporter (SGLT)-2 inhibitor in accordance with local regulations. The dose of all OAMs must have been stable for ≥90 days prior to screening

• Have an HbA1c value ≥7.5% and ≤10% according to the central laboratory at screening

• Body mass index ≤45.0 kg/m²

• Have access to a telephone, or alternative means for close monitoring/communications

• Have refrigeration at home or have ready access to refrigeration for storage of insulin therapy

• Have a regular wake-sleep schedule (awake-work during the day and sleep during the night)

Exclusion Criteria:

• Having any other condition (including known drug or alcohol abuse, psychiatric disorder including eating disorder) that precludes the subject from following and completing the protocol
• Have been diagnosed, at any time, with type 1 diabetes mellitus (T1DM) or latent autoimmune diabetes in adults
• Have hypoglycemia unawareness as judged by the investigator
• Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within the 6 months prior to screening
• Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening
• Have a known diagnosis of secondary diabetes (for example, diabetes caused by hemochromatosis, acromegaly, chronic pancreatitis, or pancreatectomy)
• Excessive insulin resistance defined as having received a total daily dose of insulin >2.0 U/kg at the time of screening
• Have a history of or are being evaluated for bariatric surgery including Roux-en-Y gastric bypass surgery, gastric banding, and/or gastric sleeve
• Have cardiovascular disease, within the past 6 months prior to screening, defined as stroke, decompensated heart failure (New York Heart Association Class III or IV), myocardial infarction, unstable angina pectoris, or coronary arterial bypass graft
• History of renal transplantation
• Currently receiving renal dialysis
• Serum creatinine >2.0 mg/dL (177 µmol/L) at screening
• Have obvious clinical signs or symptoms of liver disease (for example, acute or chronic hepatitis or cirrhosis), or elevated liver enzyme measurements
• Have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or are at an increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
• Have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hemoglobinopathy, anemia, or any other traits known to interfere with measurement of HbA1
• Have presence of clinically significant gastrointestinal disease (for example, clinically active gastroparesis associated with wide glucose fluctuations) in the investigator's opinion
• Have used thiazolidinediones, glucagon-like peptide 1 receptor agonist, or pramlintide within 90 days prior to screening