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Insulin lispro A

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: Dec 30, 2014

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

Clinical trial landscape

Insulin lispro A · 1 trial · 1 indication

Phase 1 1
NCT01133392Bioequivalence of Two Lispro FormulationsHealthy Volunteers
COMPLETED41 Analytics
PHASE1COMPLETED
Bioequivalence of Two Lispro Formulations
Healthy Volunteers
NCT0113339241
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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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