A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India (NCT06370715) | Clinical Trial Compass
CompletedPhase 4
A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India
India150 participantsStarted 2024-04-18
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* …
What they're measuring
1
Percentage of Participants with at least 1 Episode of Hypoglycemia