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Lyumjev with 50% basal rate reduction

Phase 1

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Sep 3, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

Lyumjev with 50% basal rate reduction · 1 trial · 1 indication

Phase 1 1
NCT05262387A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 DiabetesDiabetes Mellitus, Type 1
COMPLETED25 Analytics
PHASE1COMPLETED
A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes
Diabetes Mellitus, Type 1Unlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacodynamics (PD): Change in Plasma Glucose (PG) From the Start to the End of Exercise
Start (0 minute) to end of exercise (60 minutes)

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.

Secondary Endpoints

Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Versus Time Curve From Time 0 to 4 Hours [AUC(0-4)] of Postprandial Plasma Glucose (PPG) Post Mixed-Meal Tolerance Test (MMTT)
Baseline (0-hour time point prior of the MMTT), 4 hour post-meal MMTT
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Treatment Sequence 1: ADBCEXPERIMENTALPeriod 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: BACDEXPERIMENTALPeriod 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: CBDAEXPERIMENTALPeriod 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: DCABEXPERIMENTALPeriod 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.

Interventions

NameTypeDescription
Lyumjev with 50% basal rate reductionDRUGAdministered SC.
Humalog with 50% basal rate reductionDRUGAdministered SC.
Humalog with 100% basal rate reductionDRUGAdministered SC.
Lyumjev with 100% basal rate reductionDRUGAdministered SC.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female participants with type 1 diabetes * Body mass index (BMI) between 18.5 and 29.0 kilograms per square meter (kg/m²), inclusive * Hemoglobin A1c (HbA1c) less than or equal to 8.5 percent (%) * Using CSII and stable insulin regimen for at least 6 months prior to in...

Countries:Canada
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Frequently asked questions about Lyumjev with 50% basal rate reduction

What is Lyumjev with 50% basal rate reduction used for?

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.

What does Lyumjev with 50% basal rate reduction target?

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.

Who makes Lyumjev with 50% basal rate reduction?

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.

What phase is Lyumjev with 50% basal rate reduction in?

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.

What clinical trials is Lyumjev with 50% basal rate reduction in?

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.

Is Lyumjev with 50% basal rate reduction the same as LY900014?

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.