A Study of 2 Different Formulations of Insulin Lispro in Healthy Participants

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

The study involves 4 injections of insulin lispro and its purpose is to:

• Determine if 2 formulations of insulin lispro are treated by the body in a similar way.
• Compare how the 2 formulations of insulin lispro affect blood sugar level.
• Determine the safety of each insulin lispro formulations and any side effects that might be associated with them when given to healthy participants. The study is expected to last up to approximately 9 weeks for each participant.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Biological: Insulin Lispro

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117597
    • 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: 18 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 kilogram 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 (fasting blood glucose [FBG], plasma) >6 millimoles per liter (mmol/L) at screening
• Have positive hepatitis B surface antigen.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Insulin Lispro A; Insulin Lispro A 20 units (U) of strength 200 units per milliliter (U/mL) (U-200)administered subcutaneously (SC) once in two of four study periods.(Two doses of test [T]).	Biological: Insulin Lispro; LY275585 administered SC.
Experimental: Insulin Lispro B; Insulin Lispro B 20 units (U) of strength 100 U/mL (U-100) administered SC once in two of four study periods.(Two doses of reference [R]).	Biological: Insulin Lispro; LY275585 administered SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Zero to Time of Return to Baseline (AUC0-tlast)	Day 1, predose through 8 hours post dose in each period.
Pharmacokinetic Parameter: Maximum Serum Insulin Concentration (Cmax)	Day 1, predose through 8 hours post dose in each period
Pharmacokinetic Parameter: Area Under the Curve(AUC)	Zero to infinity [AUC(0-∞)]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic Parameter: Time of Maximum Observed Serum Concentration (Tmax)		Day 1, predose through 8 hours post dose in each period.
Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)	The total amount of glucose infused during the euglycemic clamp procedure.	Day1, predose through 8 hours post dose in each period.
Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)	The maximum observed glucose infusion rate during the euglycemic clamp procedure.	Day 1, predose through 8 hours post dose in each period.
Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)		Day 1, predose through 8 hours post dose in each period.

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: April 8, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimate): April 10, 2014

Study Record Updates

• Last Update Posted (Estimate): May 21, 2015
• Last Update Submitted That Met QC Criteria: May 4, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Lispro
• Other Study ID Numbers: 15418; F3Z-EW-IOQM (Other Identifier: Eli Lilly and Company)