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

Lilly

Status and phase

Enrolling

Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Insulin Lispro-aabc

Drug: Insulin Glargine

Study type

Interventional

Funder types

Industry

Identifiers

NCT06370715

18269

I8B-MC-ITTA (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

112 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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