Bioequivalence of Two Lispro Formulations

Evaluation of the Bioequivalence of Two Formulations of Insulin Lispro in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Insulin lispro A; Drug: Insulin lispro B

Detailed Description

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

Lispro A

Lispro B

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insulin Lispro A; 20 units (U) subcutaneously (SC)	Drug: Insulin lispro A; 20 units (U) subcutaneously (SC).; Other Names: LY275585
Active Comparator: Insulin lispro B; 20 units (U) subcutaneously (SC)	Drug: Insulin lispro B; 20 U subcutaneously (SC).; Other Names: LY275585

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]	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.	0 up to 8 hours post dose

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: May 27, 2010
• First Submitted That Met QC Criteria: May 27, 2010
• First Posted (Estimate): May 28, 2010

Study Record Updates

• Last Update Posted (Estimate): December 30, 2014
• Last Update Submitted That Met QC Criteria: December 29, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: insulin; lispro
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Lispro
• Other Study ID Numbers: 13300; F3Z-EW-IOPY (Other Identifier: Eli Lilly and Company)