Bioequivalence of Two Lispro Formulations

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133392
• Other study ID #: 13300
• Secondary ID: F3Z-EW-IOPY
• Status: Completed
• Phase: Phase 1
• First received: May 27, 2010
• Last updated: December 29, 2014
• Start date: May 2010
• Est. completion date: August 2010

Study information

• Verified date: December 2014
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Lispro A

Lispro B

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Insulin lispro A
20 units (U) subcutaneously (SC).
• Insulin lispro B
20 U subcutaneously (SC).

Locations

Country	Name	City	State
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.	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pharmacokinetic Parameter: Maximum Serum Insulin Concentration [Cmax]	The maximum observed insulin lispro concentration following dosing.	0 to 8 hours post dose	No
Secondary	Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)	The maximum observed glucose infusion rate during the euglycemic clamp procedure.	0 to 8 hours post dose	No
Secondary	Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)	Time of maximal glucose infusion rate.	0 to 8 hours post dose	No
Secondary	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	No