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Also known as Human regular U-500 insulin (CSII)
Human regular U-500 insulin · 1 trial · 1 indication
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline of response, glucagon-like peptide-1 (GLP-1) or sodium-glucose cotransporter 2 (SGLT2) use, U-500R at entry, treatment, time and treatment by time interaction.
| Arm | Type | Description |
|---|---|---|
| Human regular U-500 insulin administered by CSII | EXPERIMENTAL | Human regular U-500 insulin administered by CSII and titrated based on blood glucose readings for 26 weeks with a 2-week MDI lead-in. |
| Human regular U-500 insulin administered by MDI | ACTIVE_COMPARATOR | Human regular U-500 insulin administered subcutaneously (SC) by MDI three times a day and titrated based on blood glucose readings for 26 weeks. |
| Name | Type | Description |
|---|---|---|
| Human regular U-500 insulin (CSII) | DRUG | Administered SC |
| Human regular U-500 insulin (MDI) | DRUG | Administered SC |
Inclusion Criteria: * Diagnosed with type 2 diabetes mellitus (T2DM). * Current TDD \>200 but ≤600 units of non U-500R insulin (MDI or CSII) and/or U-500R by MDI with syringe and vial for ≥3 months at entry. * If TDD of U-500R and other insulins are combined, then insulin other than U-500R not t...
Human regular U-500 insulin is used to treat Type 2 Diabetes Mellitus. It is a highly concentrated form of regular human insulin, containing 500 units of insulin per milliliter, and is studied for administration in adults with Type 2 Diabetes Mellitus.
Human regular U-500 insulin works as an agonist at the insulin receptor, or INSR. By binding to and activating INSR, it produces insulin's metabolic effects, including promoting glucose uptake into tissues and lowering blood glucose levels in people with Type 2 Diabetes Mellitus.
Human regular U-500 insulin is developed by Eli Lilly and Company, which trades under the ticker LLY. The company is the sponsor of the clinical study of this concentrated insulin formulation in participants with Type 2 Diabetes Mellitus.
Human regular U-500 insulin is in Phase 3 clinical development. It is an investigational product and is not described as approved. The Phase 3 study of this drug has been completed, and no trials of this asset are currently listed as active.
Human regular U-500 insulin has been studied in the Phase 3 trial NCT02561078, titled an administration method study of Human Regular U-500 Insulin (LY041001) in participants with Type 2 Diabetes Mellitus. The trial was completed, enrolled 420 participants, was randomized, and used an active-controlled design in the United States and Puerto Rico.
Yes. Human regular U-500 insulin is also known as Human regular U-500 insulin (CSII), where CSII refers to continuous subcutaneous insulin infusion. Both names refer to the same Eli Lilly and Company concentrated regular human insulin product studied in Type 2 Diabetes Mellitus.