Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...