Bioequivalence of Two Lispro Formulations

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Insulin lispro A; Drug: Insulin lispro B

• Registration Number: NCT01133392
• Lead Sponsor: Eli Lilly and Company

Brief Summary

This study will compare how the body treats 2 different forms of insulin lispro and how they affect blood sugar levels.

Detailed Description

The 2 formulations of insulin lispro will be referred to here as:

Lispro A

Lispro B

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-27
• Study First Submitted QC: 2010-05-27
• Study First Posted: 2010-05-28
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Results First Submitted: 2014-10-10
• Status Verified: 2014-12
• Results First Submitted QC: 2014-12-29
• Last Update Submitted: 2014-12-29
• Results First Posted: 2014-12-30
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 at screening.

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Exclusion Criteria

• History of first-degree relatives known to have diabetes mellitus.
• Evidence of significant active neuropsychiatric disease.
• Evidence of an acute infection with fever or infectious disease.
• Intend to use over-the-counter or prescription medication (apart from vitamin/mineral supplements, occasional paracetamol, or birth control methods).
• Have used systemic glucocorticoids within 3 months prior to entry into the study.
• Have donated blood of 1 unit or more within the last 3 months prior to study entry.
• Excessive alcohol intake
• Have a fasting venous blood glucose (FBG, plasma) >6 millimoles/liter (mmol/L) at screening.
• Have positive hepatitis B surface antigen.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Insulin Lispro A	Insulin lispro A	20 units (U) subcutaneously (SC)
Insulin lispro B	Insulin lispro B	20 units (U) subcutaneously (SC)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)	0 to 8 hours post dose	Time of maximal glucose infusion rate.
Pharmacokinetic Parameter: Maximum Serum Insulin Concentration [Cmax]	0 to 8 hours post dose	The maximum observed insulin lispro concentration following dosing.
Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)	0 to 8 hours post dose	The maximum observed glucose infusion rate during the euglycemic clamp procedure.
Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)	0 to 8 hours post dose	The total amount of glucose infused during the euglycemic clamp procedure.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇸🇬 Singapore, Singapore