a study of ly900014 in adult participants with type 2 diabetes mellitus in india

Conditions: Diabetes Mellitus, Type 2

Summary: 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).


Eligibility criteria:
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

Keywords: diabetes mellitus, type 2 diabetes, lyumjev, basaglar, humalog