Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03952130 | A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes | PHASE3 | COMPLETED | 354 | — | — | May 29, 2019 | Jan 10, 2022 | Feb 8, 2023 | 30 | Argentina, China +1 |
| NCT03740919 | A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes | PHASE3 | COMPLETED | 751 | — | — | Apr 7, 2019 | Jul 2, 2021 | Jan 24, 2022 | 111 | United States, Austria +16 |
| NCT03214367 | A Study of LY900014 in Participants With Type 1 Diabetes | PHASE3 | COMPLETED | 1,392 | — | — | Jul 17, 2017 | Aug 22, 2019 | May 1, 2020 | 172 | United States, Argentina +18 |
| NCT03465878 | A Study of LY900014 in Participants With Type 1 Diabetes Mellitus | PHASE1 | COMPLETED | 56 | — | — | Mar 26, 2018 | Nov 14, 2019 | Jun 18, 2020 | 2 | Canada, Germany |
HbA1c is the glycosylated fraction of hemoglobin A. It 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 Baseline + Pooled Country + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Change from baseline in HbA1c was analyzed using mixed model repeated measures (MMRM) and includes fixed class effects of treatment, strata (pooled country, type of basal insulin, and age group), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. An unstructured covariance structure will be used to model the within-participant errors. The Efficacy estimand included data collected prior to permanent discontinuation of study drug through Week 26.
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC(0 -7h)) following Each Treatment Arm for Each Study Part.
| Arm | Type | Description |
|---|---|---|
| LY900014 | EXPERIMENTAL | Participants received 100 units per milliliter (U/mL) LY900014 subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. |
| Insulin Lispro (Humalog) | ACTIVE_COMPARATOR | Participants received 100 U/mL insulin lispro SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. |
| LY900014 Postmeal | EXPERIMENTAL | Participants received 100 U/mL LY900014 administered SC, up to 20 minutes after the start of the meal. |
| LY900014 Postmeal (Open Label) | EXPERIMENTAL | LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets. |
| LY900014 - Maximum Extended Enrollment (MEE) | EXPERIMENTAL | LY900014 given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets. |
| Insulin Lispro (Humalog)-MEE | ACTIVE_COMPARATOR | Insulin lispro given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets. |
| LY900014 Postmeal (Open Label)-MEE | EXPERIMENTAL | LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets. |
| LY900014-Part A | EXPERIMENTAL | Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014. |
| Humalog (Insulin Lispro)-Part A | ACTIVE_COMPARATOR | Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL of Humalog. |
| LY900014-Part B | EXPERIMENTAL | Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the continuous subcutaneous insulin infusion (CSII) pump. |
| Humalog (Insulin Lispro)-Part B | ACTIVE_COMPARATOR | Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump. |
| Name | Type | Description |
|---|---|---|
| LY900014 | DRUG | Administered SC |
| Insulin Lispro | DRUG | Administered SC |
| Insulin Glargine | DRUG | Administered SC |
| Insulin Degludec | DRUG | Administered SC |
Inclusion Criteria: * Participants must have T1D for at least 1 year prior to screening and continuously using insulin for at least 1 year. * Participants must have HbA1c of ≥7.0 and ≤10.0%. * Participants must have been treated for at least 90 days prior to screening with either multiple daily inj...