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Also known as Ultra-Rapid Lispro
LY900014-U200 · 3 trials · 2 indications
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.
Pharmacokinetics (PK): Insulin Lispro AUC time zero to 10 hours.
Insulin Lispro AUC From Time Zero to 10 hours post dose (AUC\[0-10h\])
| 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. |
| LY900014 U-200 | EXPERIMENTAL | Single subcutaneous (SC) dose of LY900014 U-200 in two of four study periods. |
| LY900014 U-100 | EXPERIMENTAL | Single SC dose of LY900014 U-100 in two of four study periods. |
| LY900014-U200 | EXPERIMENTAL | Single subcutaneous (SC) dose of 15 units (U) LY900014 U-200 in two of four study periods |
| LY900014-U100 | EXPERIMENTAL | Single SC dose of 15 U LY900014 U-100 in two of four study periods |
| Name | Type | Description |
|---|---|---|
| Ultra-Rapid Lispro | DRUG | Administered SC |
| Insulin Lispro | DRUG | Administered SC |
| LY900014 U-200 | DRUG | Administered SC |
| LY900014 U-100 | DRUG | Administered SC |
| LY900014-U200 | DRUG | Administered SC |
| LY900014-U100 | 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 ...
LY900014-U200 is an investigational small molecule developed by Eli Lilly and Company. It has been studied in Phase 1 clinical trials in healthy participants, comparing two formulations of LY900014. Both completed trials enrolled healthy volunteers in Singapore. No therapeutic indication for LY900014-U200 has been disclosed.
LY900014-U200 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored both Phase 1 trials of the asset, which were conducted in Singapore in healthy participants.
LY900014-U200 is in Phase 1 development. Two Phase 1 trials have been completed, and neither is currently active. The studies together enrolled 118 healthy participants. LY900014-U200 is investigational and has not been approved by the FDA for any indication.
Two completed Phase 1 trials studied LY900014-U200: NCT03616977, which enrolled 69 healthy participants, and NCT03334448, which enrolled 49 healthy participants. Both were randomized, double-blind, controlled studies comparing two formulations of LY900014 in healthy volunteers in Singapore. Neither trial is currently active.
Yes. LY900014-U200 and LY900014 U-200 refer to the same investigational compound from Eli Lilly and Company. The two spellings differ only in punctuation, so searches for either name point to the same Phase 1 asset studied in healthy participants.
The two completed Phase 1 trials of LY900014-U200 enrolled a total of 118 healthy participants. NCT03616977 enrolled 69 participants and NCT03334448 enrolled 49. Both studies were randomized, double-blind, and controlled, and both were conducted in Singapore.