Bioequivalence of Two Lispro Formulations

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01133392

First Posted: May 28, 2010

Last Update Posted: December 30, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Eli Lilly and Company

Purpose

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

Condition	Intervention	Phase
Healthy Volunteers	Drug: Insulin lispro A Drug: Insulin lispro B	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Evaluation of the Bioequivalence of Two Formulations of Insulin Lispro in Healthy Subjects

Resource links provided by NLM:

Drug Information available for: Insulin Insulin human Insulin lispro

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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] [ Time Frame: 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:

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


Enrollment:	41
Study Start Date:	May 2010
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Insulin Lispro A 20 units (U) subcutaneously (SC)	Drug: Insulin lispro A 20 units (U) subcutaneously (SC). Other Name: LY275585
Active Comparator: Insulin lispro B 20 units (U) subcutaneously (SC)	Drug: Insulin lispro B 20 U subcutaneously (SC). Other Name: LY275585

Detailed Description:

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

Lispro A

Lispro B

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	21 Years to 50 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01133392

Locations


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, Singapore

Sponsors and Collaborators

Eli Lilly and Company

Investigators


Study Director:	Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company

More Information


Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01133392 History of Changes
Other Study ID Numbers:	13300 F3Z-EW-IOPY ( Other Identifier: Eli Lilly and Company )
First Submitted:	May 27, 2010
First Posted:	May 28, 2010
Results First Submitted:	October 10, 2014
Results First Posted:	December 30, 2014
Last Update Posted:	December 30, 2014
Last Verified:	December 2014

Keywords provided by Eli Lilly and Company:


insulin lispro

Additional relevant MeSH terms:


Insulin, Globin Zinc Insulin Insulin Lispro Hypoglycemic Agents Physiological Effects of Drugs

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