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Insulin lispro A

Phase 1

Undisclosed | Small molecule | Other |Eli Lilly and Company|Trials Updated: Dec 30, 2014

Insulin lispro A development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since May 2010

Insulin lispro A target and mechanism

Molecular targetINSR
Target classAgonist
ModalitySmall molecule

Also known as LY275585

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Insulin lispro A clinical trials

Insulin lispro A · 1 trial · 1 indication

Phase 1 1
NCT01133392Bioequivalence of Two Lispro FormulationsHealthy Volunteers
COMPLETED41 Analytics
PHASE1COMPLETED
Bioequivalence of Two Lispro Formulations
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Study Endpoints

Primary Endpoints

Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC0-tlast]
0 up to 8 hours post dose

Primary outcome measure is based on the pharmacokinetic area under the concentration-time curve from time 0 to the last time point with a measurable concentration.

Secondary Endpoints

Pharmacokinetic Parameter: Maximum Serum Insulin Concentration [Cmax]
0 to 8 hours post dose
Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)
0 to 8 hours post dose
Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)
0 to 8 hours post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Insulin Lispro AEXPERIMENTAL20 units (U) subcutaneously (SC)
Insulin lispro BACTIVE_COMPARATOR20 units (U) subcutaneously (SC)

Interventions

NameTypeDescription
Insulin lispro ADRUG20 units (U) subcutaneously (SC).
Insulin lispro BDRUG20 U subcutaneously (SC).
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Eligibility Criteria

Age Range21 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are healthy males or females. * Body mass index (BMI) between 18.5 and 29.9 kilograms per meter squared (kg/m\^2) * Are nonsmokers. * Have normal blood pressure and pulse rate, a normal electrocardiogram (ECG), and clinical laboratory test results within normal reference range...

Countries:Singapore
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Frequently asked questions about Insulin lispro A

What is Insulin lispro A?

Insulin lispro A is an investigational small molecule developed by Eli Lilly and Company. It acts as an agonist at the insulin receptor (INSR). It has been studied in a Phase 1 bioequivalence trial in healthy volunteers. No approved indication has been disclosed for this asset.

What does Insulin lispro A target?

Insulin lispro A targets the insulin receptor, also known as INSR. It is classified as an INSR agonist, meaning it activates this receptor. The insulin receptor plays a central role in glucose regulation, and agonism of INSR is the mechanism of action for this investigational agent.

Who makes Insulin lispro A?

Insulin lispro A is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Eli Lilly is the sponsor of the clinical program for this asset.

What phase is Insulin lispro A in?

Insulin lispro A is in Phase 1 clinical development. It is an investigational drug and has not been approved for any indication. The Phase 1 program consists of one completed trial, with no active trials currently listed.

What clinical trials is Insulin lispro A in?

Insulin lispro A has been evaluated in one completed Phase 1 trial, NCT01133392, titled Bioequivalence of Two Lispro Formulations. The trial enrolled 41 healthy volunteers in Singapore, was randomized and active-controlled, and did not use double blinding. No active trials are listed.