Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ultra-Rapid Lispro · 1 trial · 1 indication
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured 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 covariates: Baseline + Pooled Country + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag + Treatment + Time + Treatment\*Time (Type III sum of squares). The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.
| Arm | Type | Description |
|---|---|---|
| Insulin Lispro (Humalog) | ACTIVE_COMPARATOR | Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. |
| Ultra-Rapid Lispro | EXPERIMENTAL | Participants received individual dose of 100 units per milliliter (U/mL) ultra rapid lispro by continuous subcutaneous insulin infusion (CSII); where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. |
| Name | Type | Description |
|---|---|---|
| Ultra-Rapid Lispro | DRUG | Administered SC |
| Insulin Lispro | DRUG | Administered SC |
Inclusion Criteria: * Have been diagnosed with T1D and continuously using insulin for at least 1 year * Have been using CSII therapy for a minimum of 6 months * Currently treated with \<100 Units of one of following rapid-acting analog insulin via CSII for at least the past 30 days: insulin lispro ...
Ultra-Rapid Lispro is an investigational small molecule being developed for the treatment of Type 1 Diabetes Mellitus. It is designed to be used in adults with this condition, as studied in a Phase 3 clinical trial involving insulin pump therapy.
Ultra-Rapid Lispro is being developed by Eli Lilly and Company, a pharmaceutical company publicly traded under the ticker symbol LLY on the stock exchange.
Ultra-Rapid Lispro is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy.
Ultra-Rapid Lispro has one completed Phase 3 clinical trial with the identifier NCT03830281. This trial compared Ultra-Rapid Lispro to Insulin Lispro (Humalog) in adults with Type 1 Diabetes Mellitus using insulin pump therapy. The trial enrolled 471 participants across multiple countries.
Ultra-Rapid Lispro is not the same as Insulin Lispro (Humalog). In the clinical trial NCT03830281, Ultra-Rapid Lispro was compared directly against Insulin Lispro as an active control, indicating they are distinct drug products being evaluated for similar use in Type 1 Diabetes Mellitus.