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LY900014

Phase 3

Diabetes Type 1 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Mar 3, 2023

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment49

FDA Designations

No designations recorded

Clinical trial landscape

LY900014 · 29 trials · 10 indications

Phase 3 7Phase 2 2Phase 1 20
NCT04605991A Study of Mealtime Insulin LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range)Type 2 Diabetes
COMPLETED187 Analytics
NCT03952130A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 DiabetesType 1 Diabetes Mellitus
COMPLETED354 Analytics
NCT03952143A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 DiabetesType 2 Diabetes Mellitus
COMPLETED628 Analytics
NCT03740919A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 DiabetesType 1 Diabetes Mellitus
COMPLETED751 Analytics
NCT03433677A Study of LY900014 and Insulin Lispro With an External Continuous Subcutaneous Insulin Infusion System in Adult Participants With Type 1 DiabetesDiabetes Type 1
COMPLETED49 Analytics
NCT03214367A Study of LY900014 in Participants With Type 1 DiabetesType 1 Diabetes Mellitus
COMPLETED1,392 Analytics
NCT03214380A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 DiabetesType 2 Diabetes Mellitus
COMPLETED933 Analytics
PHASE3COMPLETED
A Study of Mealtime Insulin LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range)
Type 2 Diabetes
NCT04605991187
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PHASE3COMPLETED
A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes
Type 1 Diabetes Mellitus
NCT03952130354
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PHASE3COMPLETED
A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes
Type 2 Diabetes Mellitus
NCT03952143628
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PHASE3COMPLETED
A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes
Type 1 Diabetes Mellitus
NCT03740919751
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PHASE3COMPLETED
A Study of LY900014 and Insulin Lispro With an External Continuous Subcutaneous Insulin Infusion System in Adult Participants With Type 1 Diabetes
Diabetes Type 1
NCT0343367749
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PHASE3COMPLETED
A Study of LY900014 in Participants With Type 1 Diabetes
Type 1 Diabetes Mellitus
NCT032143671,392
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PHASE3COMPLETED
A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes
Type 2 Diabetes Mellitus
NCT03214380933
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Study Endpoints

Primary Endpoints

Change From Baseline in Percentage of Time With Continuous Glucose Monitoring (CGM) Sensor Glucose Values Between 70-180 Milligrams/Deciliter (mg/dL) (3.9-10.0 Millimoles/Liter [mmol/L]) (Both Inclusive) During Daytime Period at Week 12
Baseline, Week 12

Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Time as variables.

Change From Baseline in Hemoglobin A1c (HbA1c)
Baseline, Week 26

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 Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26
Baseline, Week 26

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.

Rate of Infusion Set Failures
6 Weeks

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 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM)
Day 46

Percentage of Time with Sensor Glucose Values Between 70 and 180 mg/dL (both inclusive) with CGM.

Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) (24-Hour)
Week 2 through Week 4

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 Following Administration of LY900014 and Insulin Lispro (Humalog) After Missed Meal Bolus
Day 1: Baseline up to 5 hours after missed meal bolus

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 Following Administration of LY900014 and Insulin Lispro (Humalog) After Pump Suspension
Day 2: Baseline up to 5 hours after pump suspension

Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 mg/dL.

Pharmacokinetics (PK): Insulin Lispro Area Under the Serum Concentration Versus Time Curve From Time Zero to 10 Hours Postdose (AUC[0-10h])
Day 1: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes postdose

PK: Insulin Lispro AUC(0-10h)

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) Following Each Treatment Arm for Each Study Part
Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes postdose

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC(0 -7h)) following Each Treatment Arm for Each Study Part.

Pharmacokinetics (PK): Insulin Lispro or Insulin Aspart Area Under the Concentration Curve From Zero to Seven Hours (AUC 0-7h) Following Administration of Each Study Arm
0 (predose), 1, 2, 3,5,10, 15, 20, 25, 30,35, 40, 45, 50, 55,60, 70, 90, 120, 150,180, 240, 300, 360 and 420 minutes postdose

PK: Insulin Lispro or Insulin Aspart AUC(0-7h)

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve Zero to 10 Hours (AUC 0-10h) Following Administration of Each Treatment Arm
Predose, 5 minutes (min), 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min, 45 min, 50 min, 55 min, 60 min, 70 min, 90 min, 120 min, 150 min, 180 min, 240 min, 300 min, 360 min, 420 min, 480 min, 540 min, and 600 min postdose

PK: Insulin Lispro AUC from time zero to 10 hours

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve Zero to Seven Hours (AUC0-7hr)
Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes (7 hours) postdose

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 (PK): Insulin Lispro Area Under the Concentration Curve (AUC)
Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, and 420 minutes (7 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 .

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Versus Time Curve (AUC)
Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose

Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours Post Dose \[AUC(0-10h)\]

Pharmacokinetics (PK): Insulin Lispro Area Under the Plasma Concentration Curve Zero to 10 Hours (AUC[0-10) Following Each Treatment Arm
Predose, 5 minutes (mn), 10mn, 15mn, 20mn, 25mn, 30mn, 35mn, 40mn,45 mn,50mn, 55mn, 60mn, 70mn, 90mn, 120mn, 150mn, 180mn, 240mn, 300mn, 360mn, 420mn, 480mn, 540mn, and 600 minutes(10 hours) postdose

Pharmacokinetics(PK): Insulin Lispro AUC from zero to 10 hours postdose \[AUC(0-10)\] following each treatment arm

Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) Following LY900014 Administration
Day 1: Pre-dose, 2.5, 5, 10, 15, 20, 25, 30, 40, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose

Pharmacokinetics(PK): Insulin lispro AUC from time zero to 10 hours post dose \[AUC(0-10h)\].

Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) for Each Treatment Arm
Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose

Pharmacokinetics: Insulin lispro AUC from time zero to 10 hours postdose \[AUC(0-10h)\] for each treatment arm.

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours(h) (AUC [0-5 h]) Following Administration of Each Study Arm With a Standard Single-wave Bolus
Days 1 and 3: -15, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes post dose

PK: Insulin Lispro AUC(0-5h)

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC [0-5 h]) of Following Administration of Each Study Arm With a Standard Dual-wave Bolus
Days 1 and 3: -15, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes post dose

PK: Insulin Lispro AUC(0-5h)

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours])
Predose (0), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 210, 240, 300, 330, 360, 420, and 480 minutes, post dose

Area Under the Concentration Versus Time Curve (AUC) was measured from time zero to 8 hours (AUC\[0-8 Hours\]).

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part A)
Day 1: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, 300 minutes post dose for each treatment

PK: Insulin Lispro AUC(0-5h) (Part A)

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part B)
Days 1 and 14: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, 300 minutes post dose for each treatment

PK: Insulin Lispro AUC(0-5h) (Part B)

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h])
Days 1 and 3: -15, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300 minutes post dose for each treatment

PK: Insulin Lispro AUC(0-5h)

Pharmacokinetics (PK): Area Under The Concentration Curve (AUC 0-30mins) of Insulin Lispro
Predose,5,10,15,20,25,30,35,40,45,50,55,60,70,90,120,150,180,240,300, 360 and 420 minutes postdose
Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) )
5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes per period.
Part A: Pharmacokinetics (PK ): Area Under the Concentration Curve From Zero to the Last Recorded Time Post Dose (AUC0-tlast)
30 minutes predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose

Secondary Endpoints

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
Baseline, Week 12
Change From Baseline in Percentage of Time With CGM Sensor Glucose Values Between 70-180 mg/dL (3.9-10.0 mmol/L) (Both Inclusive) During the 24-hour Period at Week 12
Baseline, Week 12
Change From Baseline in Percentage of Time With CGM Sensor Glucose Values <54 mg/dL (<3.0 mmol/L) During Daytime and 24-hour Periods at Week 12
Baseline, Week 12
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LY900014EXPERIMENTALLY900014 (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_COMPARATORParticipants 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 LisproACTIVE_COMPARATORParticipants 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 PostmealEXPERIMENTALParticipants received 100 U/mL LY900014 administered SC, up to 20 minutes after the start of the meal.
LY900014 Postmeal (Open Label)EXPERIMENTALLY900014 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)EXPERIMENTALLY900014 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)-MEEACTIVE_COMPARATORInsulin 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)-MEEEXPERIMENTALLY900014 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)EXPERIMENTALLY900014 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) MEEACTIVE_COMPARATORInsulin 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 DegludecEXPERIMENTALLY900014 (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 LY900014EXPERIMENTAL100 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_COMPARATOR100 U/mL Insulin Lispro (Humalog) administered by CSII in one of two study periods.
LY900014-Part AEXPERIMENTALParticipants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014.
Humalog (Insulin Lispro)-Part AACTIVE_COMPARATORParticipants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL of Humalog.
LY900014-Part BEXPERIMENTALParticipants 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 BACTIVE_COMPARATORParticipants 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_COMPARATORT1DM participants received a single, individualized, SC dose of insulin lispro.
Insulin Aspart (NovoRapid®)ACTIVE_COMPARATORT1DM participants received a single, individualized, SC dose of insulin aspart.
Insulin Aspart (Fiasp®)ACTIVE_COMPARATORT1DM participants received a single, individualized, SC dose of insulin aspart.
Healthy ParticipantsNO_INTERVENTIONHealthy participants who received no study drug.
LY900014 Before MealEXPERIMENTALIndividualized dose of LY900014 administered subcutaneously (SC) immediately before meal in one of four study periods.
LY900014 After MealEXPERIMENTALIndividualized dose of LY900014 administered SC 20 minutes after start of meal in one of four study periods.
Insulin Lispro (Humalog) Before MealACTIVE_COMPARATORIndividualized dose of insulin lispro administered SC immediately before meal in one of four study periods.
Insulin Lispro (Humalog) After MealACTIVE_COMPARATORIndividualized dose of insulin lispro administered SC 20 minutes after start of meal in one of four study periods.
LY900014 (SC Abdomen)EXPERIMENTALSingle dose of 15-U of LY900014 administered subcutaneously (SC) into the abdomen in one period
LY900014 (SC Thigh)EXPERIMENTALSingle dose of 15-U of LY900014 administered SC into the thigh in one period
LY900014 (SC Arm)EXPERIMENTALSingle dose of 15-U of LY900014 administered SC into the arm (deltoid) in one period
LY900014 (IV)ACTIVE_COMPARATORSingle dose of 15-U of LY900014 administered intravenously (IV) in one period
Elderly Adults LY900014EXPERIMENTALSingle, subcutaneous (SC) 15-U dose of LY900014 in the elderly adult group.
Elderly Adults Insulin LisproACTIVE_COMPARATORSingle, SC 15-U dose of insulin lispro (Humalog) in in the elderly adult group.
Younger Adults LY900014EXPERIMENTALSingle, SC 15-U dose of LY900014 in the younger adult group.
Younger Adults Insulin LisproACTIVE_COMPARATORSingle, SC 15-U dose of insulin lispro (Humalog) in the younger adult group.
U-193 LY900014 TestEXPERIMENTALLY900014 test dose administered via subcutaneous (SC) injection
U-95 LY900014 ReferenceACTIVE_COMPARATORLY900014 reference dose administered via SC injection
LY900014 - Test (Part A)EXPERIMENTALIndividualized doses of LY900014 administered by injection under the skin once in each of 3 periods
Insulin Lispro - Reference (Part A)ACTIVE_COMPARATORIndividualized doses of insulin lispro reference formulation administered by injection under the skin once in each of 3 periods
LY900014 - Test (Part B)EXPERIMENTALIndividualized doses of LY900014 administered by injection under the skin immediately before each meal for 14 days
Insulin Lispro - Reference (Part B)ACTIVE_COMPARATORIndividualized doses of insulin lispro reference formulation administered by injection under the skin immediately before each meal for 14 days
LY900014 (Part A)EXPERIMENTALIndividualized doses of LY900014 administered by injection under the skin once in each of 3 periods
LY900014 (Part B)EXPERIMENTALIndividualized doses of LY900014 administered by injection under the skin with each meal for 14 days
LY900014 Test BEXPERIMENTALTest formulation B: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods
LY900014 Test AEXPERIMENTALTest formulation B: Single dose of LY900014 formulation administered SC in one of five periods
LY900014 Test CEXPERIMENTALTest formulation C: Single dose of LY900014 formulation administered SC in one of five periods
LY900014 Test DEXPERIMENTALFormulation D: Single dose of LY900014 formulation administered SC in one of five periods
LY900014 7.5 Units (U)EXPERIMENTALSingle dose of 7.5 U LY900014 administered subcutaneously (SC) in one to two of five periods.
LY900014 15 UEXPERIMENTALSingle dose of 15 U LY900014 administered subcutaneously (SC) in one to two of five periods.
LY900014 30 UEXPERIMENTALSingle dose of 30 U LY900014 administered subcutaneously (SC) in one to two of five periods.
Part A: LY900014 Test AEXPERIMENTALTest Formulation A. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.
Part A:Insulin LisproEXPERIMENTALReference formulation. 15 U insulin lispro administered SC in one of five periods.
Part A: LY900014 Test BEXPERIMENTALTest Formulation B. Single dose LY900014 administered subcutaneously (SC) in one of five periods.
Part A: LY900014 Test CEXPERIMENTALTest Formulation C. Single dose LY900014administered subcutaneously (SC) in one of five periods.
Part A: LY900014 Test DEXPERIMENTALTest Formulation D. Single dose LY900014administered subcutaneously (SC) in one of five periods.
Part B: LY900014EXPERIMENTALTest formulation selected from Part A. Single dose of LY900014 administered SC in one of four periods.

Interventions

NameTypeDescription
LY900014DRUGAdministered SC
Insulin GlargineDRUGAdministered SC
Insulin LisproDRUGAdministered SC
Insulin DegludecDRUGAdministered SC
MetforminDRUGAdministered orally.
SGLT2 inhibitorDRUGAdministered orally.
Insulin AspartDRUGAdministered SC
LY900014 (SC)DRUGAdministered SC
LY900014 (IV)DRUGAdministered IV
Insulin Lispro (Humalog)DRUGAdministered SC
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites32

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 ...

Countries:United StatesPuerto RicoArgentinaChinaMexicoAustriaBrazilCzechiaDenmarkFranceGermanyIsraelItalyJapanPolandRussiaSpainUkraineUnited KingdomAustraliaGreeceIndiaNew ZealandRomaniaSlovakiaSwedenTaiwanHungarySouth KoreaCanadaSingapore
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Competitive Landscape -Diabetes Complications 6 trials (matched to "Diabetes Type 1")

CompanyTickerTrialsLead PhaseDrugs
FibroBiologics, Inc.FBLG1PHASE1Undisclosed
MiMedx Group, Inc.MDXG2N/AUndisclosed
Integra LifeSciences Holdings CorporationIART1N/AUndisclosed
Organogenesis Holdings, Inc. Class AORGO1N/AUndisclosed
Healthcare Services Group, Inc.HCSG1N/AUndisclosed
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Frequently asked questions about LY900014

What is LY900014 used for?

LY900014 is an investigational small molecule being developed for Type 1 Diabetes and Type 2 Diabetes. It is studied in participants with Type 2 Diabetes on insulin injection therapy and in healthy participants. The drug is in Phase 1 clinical development and is not yet approved.

Who makes LY900014?

LY900014 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker LLY. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and efficacy in diabetes.

What phase is LY900014 in?

LY900014 is in Phase 1 clinical development. All eight clinical trials for LY900014 have been completed, with no active trials currently ongoing. The drug remains investigational and has not received regulatory approval.

What clinical trials is LY900014 in?

LY900014 has been studied in several completed Phase 1 trials, including NCT02703337 in participants with Type 2 Diabetes on insulin therapy, NCT03232983 in healthy participants, NCT03286751 comparing LY900014 to insulin lispro in healthy participants, and NCT03341312 comparing LY900014 to insulin lispro in Type 2 Diabetes.

Is LY900014 the same as insulin lispro?

LY900014 is not the same as insulin lispro. Clinical trials have been conducted to compare LY900014 to insulin lispro (Humalog) in healthy participants and in participants with Type 2 Diabetes Mellitus. These comparative studies aim to evaluate differences between the two treatments.