Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ADMELOG is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 ) FDA label
Also known as Insulin lispro (Humalog), Lispro, Lispro Prandial Insulin, Insulin Lispro (U100), Lispro SC, LY275585, Humalog, Ultra-Rapid Lispro
Insulin Lispro · 26 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.
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.
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.
Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over the last 8-12 weeks. Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline HbA1c (\>8% or ≤8%) and participants.
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.
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. |
| 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 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. |
| Insulin Lispro, then Insulin Aspart | ACTIVE_COMPARATOR | Insulin lispro \[100 units/milliliter (U/mL)\] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2. |
| Insulin Aspart, then Insulin Lispro | ACTIVE_COMPARATOR | Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2. |
| 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. |
| 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. |
| AID System Containing Insulin Lispro | EXPERIMENTAL | The AID system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a hybrid closed-loop control (HCLC) algorithm, and a continuous glucose monitor (CGM) component. |
| 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 |
| Ultra-Rapid Lispro | DRUG | Administered SC |
| Metformin | DRUG | Administered orally. |
| SGLT2 inhibitor | DRUG | Administered orally. |
| Insulin Aspart | DRUG | Insulin aspart (100 U/mL) administered by CSII pump |
| AID System | DEVICE | AID system |
| 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 ...
Insulin Lispro is used to treat Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus. It is a rapid-acting prandial insulin given to control blood glucose, including in people using insulin pump therapy. It is developed by Eli Lilly and Company under the ticker LLY.
Insulin Lispro targets INSR, the insulin receptor, and acts as an agonist at that receptor. By activating the insulin receptor, it produces a rapid blood glucose lowering effect when used as prandial insulin in Type 1 and Type 2 Diabetes Mellitus.
Insulin Lispro is made by Eli Lilly and Company, which trades under the ticker LLY. Eli Lilly is the developer of the asset across its diabetes programs, including the Phase 3 study of Insulin Lispro versus insulin aspart in Type 2 Diabetes Mellitus patients on insulin pump therapy.
Insulin Lispro is in Phase 3 development for Type 2 Diabetes Mellitus and Type 1 Diabetes Mellitus. It is an investigational and marketed insulin product studied in active-controlled, randomized, double-blind trials, including a Phase 3 comparison against insulin aspart in insulin pump users.
Insulin Lispro has been studied in completed trials including NCT01474538, a Phase 3 safety and efficacy study versus insulin aspart in 122 participants with Type 2 Diabetes Mellitus on insulin pump therapy, and NCT03367390, a Phase 1 study of an automated insulin delivery system in 30 participants with Type 1 Diabetes Mellitus.
Yes, Insulin Lispro is also known as Humalog. Other names used for the same product include Lispro, Lispro Prandial Insulin, Insulin Lispro (U100), and Lispro SC. These names all refer to the same rapid-acting insulin receptor agonist developed by Eli Lilly and Company.