Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LY900014
Lyumjev with 50% basal rate reduction · 24 trials · 8 indications
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Time as variables.
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.
Infusion set failure events are defined as premature infusion set changes, due to a pump occlusion alarm OR due to unexplained hyperglycemia with blood glucose (SMBG) \>250 milligrams per deciliter (mg/dL) (13.9 millimoles per liter \[mmol/L\]) that does not decrease within 1 hour following a correction bolus delivered via the pump during the 6 week treatment period. Aggregate rate was calculated for each participant as the total number of events while the participant is on study treatment divided by the days of exposure \[last dose date and time -first dose date and time -duration of pump or treatment interruption\] times 30.
Percentage of Time with Sensor Glucose Values Between 70 and 180 mg/dL (both inclusive) with CGM.
Least Square (LS) mean was determined by mixed-model repeated measures (MMRM) with baseline, period, sequence, strata (Hemoglobin A1c (HbA1c) \[\<=7.0%, \>7.0%\] and percentage of time with sensor glucose values from 70 to 180 mg/dL over the 2 weeks prior to randomization \[\<=75%, \>75%\]), treatment (Type III sum of squares) as fixed factors.
Changes in PG from the start (0 minute) to end of exercise (60 minutes) were analyzed using a mixed-effect model. The model included treatment (Lyumjev with 50% basal reduction, Lyumjev with 100% basal reduction, Humalog with 50% basal reduction, and Humalog with 100% basal reduction), sequence, period, timepoint, treatment-by-timepoint interaction as fixed effects, and participant-within-sequence as a random effect.
Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 Milligrams per deciliter (mg/dL).
Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 mg/dL.
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC(0 -7h)) following Each Treatment Arm for Each Study Part.
PK: Insulin Lispro or Insulin Aspart AUC(0-7h)
PK: Insulin Lispro AUC from time zero to 10 hours
PK: Insulin Lispro AUC for Each Treatment Arm. LY900014 before and after meal and insulin lispro (Humalog) before and after meal were pooled by treatment to evaluate the overall PK of LY900014 and insulin lispro (Humalog) per protocol .
PK: Insulin Lispro AUC for Each Treatment Arm. PK: Insulin Lispro AUC for Each Treatment Arm. LY900014 before and after meal and insulin lispro (Humalog) before and after meal were pooled by treatment to evaluate the overall PK of LY900014 and insulin lispro (Humalog) per protocol .
Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours Post Dose \[AUC(0-10h)\]
Pharmacokinetics(PK): Insulin Lispro AUC from zero to 10 hours postdose \[AUC(0-10)\] following each treatment arm
Pharmacokinetics(PK): Insulin lispro AUC from time zero to 10 hours post dose \[AUC(0-10h)\].
Pharmacokinetics: Insulin lispro AUC from time zero to 10 hours postdose \[AUC(0-10h)\] for each treatment arm.
PK: Insulin Lispro AUC(0-5h)
PK: Insulin Lispro AUC(0-5h)
PK: Insulin Lispro AUC(0-5h)
PK: Insulin Lispro AUC(0-5h) (Part A)
PK: Insulin Lispro AUC(0-5h) (Part B)
| Arm | Type | Description |
|---|---|---|
| LY900014 | EXPERIMENTAL | LY900014 (100 units/milliliter (U/mL)) is a mealtime insulin administered subcutaneously (SC) 0-2 minutes prior to each meal in combination with insulin glargine (100 U/mL) SC as long-acting insulin. Mealtime (bolus) and long-acting (basal) insulin doses were titrated to achieve glucose targets during the study. |
| 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. |
| Insulin Lispro | ACTIVE_COMPARATOR | Participants received 100 U/mL insulin lispro (Humalog) given 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 Maximum Extended Enrollment (MEE) | EXPERIMENTAL | LY900014 given subcutaneously (SC) with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets. |
| Insulin Lispro (Humalog) MEE | ACTIVE_COMPARATOR | Insulin lispro given SC with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets. |
| LY900014 + Insulin Degludec | EXPERIMENTAL | LY900014 (100 units/milliliter (U/mL)) is a prandial insulin administered subcutaneously (SC) 0-2 minutes before meals. Insulin degludec (100 U/mL) is a basal insulin administered once daily SC. Participants received individually adjusted insulin doses during the 35-day titration period. The target glucose values were: fasting glucose 80-110 milligrams per deciliter (mg/dL), overnight glucose excursion (the difference between bedtime and prebreakfast glucose levels) \< or = +/- 30 mg/dL, postprandial glucose peak \<140 mg/dL or \<20% increase from premeal level. Following the titration period, there was an 11-day maintenance period during which the doses were kept unchanged unless for safety reasons. |
| Treatment Sequence 1: ADBC | EXPERIMENTAL | Period 1: Lyumjev with 50% basal rate reduction (Treatment A) Period 2: Humalog with 100% basal rate reduction (Treatment D) Period 3: Lyumjev with 100% basal rate reduction (Treatment B) Period 4: Humalog with 50% basal rate reduction (Treatment C) Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously. |
| Treatment Sequence 2: BACD | EXPERIMENTAL | Period 1: Lyumjev with 100% basal rate reduction (Treatment B) Period 2: Lyumjev with 50% basal rate reduction (Treatment A) Period 3: Humalog with 50% basal rate reduction (Treatment C) Period 4: Humalog with 100% basal rate reduction (Treatment D) Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously. |
| Treatment Sequence 3: CBDA | EXPERIMENTAL | Period 1: Humalog with 50% basal rate reduction (Treatment C) Period 2: Lyumjev with 100% basal rate reduction (Treatment B) Period 3: Humalog with 100% basal rate reduction (Treatment D) Period 4: Lyumjev with 50% basal rate reduction (Treatment A) Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously. |
| Treatment Sequence 4: DCAB | EXPERIMENTAL | Period 1: Humalog with 100% basal rate reduction (Treatment D) Period 2: Humalog with 50% basal rate reduction (Treatment C) Period 3: Lyumjev with 50% basal rate reduction (Treatment A) Period 4: Lyumjev with 100% basal rate reduction (Treatment B) Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously. |
| 100 U/mL LY900014 | EXPERIMENTAL | 100 units per milliliter (U/mL) LY900014 administered by continuous subcutaneous insulin infusion (CSII) in one of two study periods. |
| 100 U/mL Insulin Lispro (Humalog) | ACTIVE_COMPARATOR | 100 U/mL Insulin Lispro (Humalog) administered by CSII in one of two study periods. |
| 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. |
| Insulin Lispro (Humalog®) | ACTIVE_COMPARATOR | T1DM participants received a single, individualized, SC dose of insulin lispro. |
| Insulin Aspart (NovoRapid®) | ACTIVE_COMPARATOR | T1DM participants received a single, individualized, SC dose of insulin aspart. |
| Insulin Aspart (Fiasp®) | ACTIVE_COMPARATOR | T1DM participants received a single, individualized, SC dose of insulin aspart. |
| Healthy Participants | NO_INTERVENTION | Healthy participants who received no study drug. |
| LY900014 Before Meal | EXPERIMENTAL | Individualized dose of LY900014 administered subcutaneously (SC) immediately before meal in one of four study periods. |
| LY900014 After Meal | EXPERIMENTAL | Individualized dose of LY900014 administered SC 20 minutes after start of meal in one of four study periods. |
| Insulin Lispro (Humalog) Before Meal | ACTIVE_COMPARATOR | Individualized dose of insulin lispro administered SC immediately before meal in one of four study periods. |
| Insulin Lispro (Humalog) After Meal | ACTIVE_COMPARATOR | Individualized dose of insulin lispro administered SC 20 minutes after start of meal in one of four study periods. |
| LY900014 (SC Abdomen) | EXPERIMENTAL | Single dose of 15-U of LY900014 administered subcutaneously (SC) into the abdomen in one period |
| LY900014 (SC Thigh) | EXPERIMENTAL | Single dose of 15-U of LY900014 administered SC into the thigh in one period |
| LY900014 (SC Arm) | EXPERIMENTAL | Single dose of 15-U of LY900014 administered SC into the arm (deltoid) in one period |
| LY900014 (IV) | ACTIVE_COMPARATOR | Single dose of 15-U of LY900014 administered intravenously (IV) in one period |
| Elderly Adults LY900014 | EXPERIMENTAL | Single, subcutaneous (SC) 15-U dose of LY900014 in the elderly adult group. |
| Elderly Adults Insulin Lispro | ACTIVE_COMPARATOR | Single, SC 15-U dose of insulin lispro (Humalog) in in the elderly adult group. |
| Younger Adults LY900014 | EXPERIMENTAL | Single, SC 15-U dose of LY900014 in the younger adult group. |
| Younger Adults Insulin Lispro | ACTIVE_COMPARATOR | Single, SC 15-U dose of insulin lispro (Humalog) in the younger adult group. |
| LY900014 (Part A) | EXPERIMENTAL | Individualized doses of LY900014 administered by injection under the skin once in each of 3 periods |
| Insulin Lispro - Reference (Part A) | ACTIVE_COMPARATOR | Individualized doses of insulin lispro reference formulation administered by injection under the skin once in each of 3 periods |
| LY900014 (Part B) | EXPERIMENTAL | Individualized doses of LY900014 administered by injection under the skin with each meal for 14 days |
| Insulin Lispro - Reference (Part B) | ACTIVE_COMPARATOR | Individualized doses of insulin lispro reference formulation administered by injection under the skin with each meal for 14 days |
| LY900014 - Test (Part A) | EXPERIMENTAL | Individualized doses of LY900014 administered by injection under the skin once in each of 3 periods |
| LY900014 - Test (Part B) | EXPERIMENTAL | Individualized doses of LY900014 administered by injection under the skin immediately before each meal for 14 days |
| Name | Type | Description |
|---|---|---|
| LY900014 | DRUG | Administered SC |
| Insulin Glargine | DRUG | Administered SC |
| Insulin Lispro | DRUG | Administered SC |
| Insulin Degludec | DRUG | Administered SC |
| Metformin | DRUG | Administered orally. |
| SGLT2 inhibitor | DRUG | Administered orally. |
| Lyumjev with 50% basal rate reduction | DRUG | Administered SC. |
| Humalog with 50% basal rate reduction | DRUG | Administered SC. |
| Humalog with 100% basal rate reduction | DRUG | Administered SC. |
| Lyumjev with 100% basal rate reduction | DRUG | Administered SC. |
| Insulin Aspart | DRUG | Administered SC |
| LY900014 (SC) | DRUG | Administered SC |
| LY900014 (IV) | DRUG | Administered IV |
| Insulin Lispro (Humalog) | DRUG | Administered SC |
Inclusion Criteria: * Participants diagnosed (clinically) with type 2 diabetes mellitus (T2D) for at least 1 year prior to screening. * Have been treated with basal-bolus multiple daily injection (MDI) therapy for at least 90 days prior to screening including: * Basal insulin glargine U-100, in ...
Lyumjev with 50% basal rate reduction is used for the treatment of Type 1 Diabetes Mellitus. It is an investigational small molecule being developed by Eli Lilly and Company. The drug is intended to manage blood glucose levels in patients with this condition.
Lyumjev with 50% basal rate reduction targets insulin receptors. It is a form of insulin lispro, a rapid-acting insulin analog, that works by replacing the insulin normally produced by the body to help regulate blood sugar levels in patients with Type 1 Diabetes Mellitus.
Lyumjev with 50% basal rate reduction is developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with Type 1 Diabetes Mellitus.
Lyumjev with 50% basal rate reduction is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied in a clinical trial to assess its effects in participants with Type 1 Diabetes Mellitus.
Lyumjev with 50% basal rate reduction is associated with one completed clinical trial, NCT05262387, titled 'A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes'. This Phase 1 trial enrolled 25 participants in Canada and was a randomized, double-blind, controlled study.
Yes, Lyumjev with 50% basal rate reduction is the same as LY900014. The clinical trial NCT05262387 refers to the drug as LY900014 (Lyumjev). This naming is used in the study to identify the investigational product being evaluated in participants with Type 1 Diabetes Mellitus.