Bioequivalence of Two Lispro Formulations
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ClinicalTrials.gov Identifier: NCT01133392 |
Recruitment Status
:
Completed
First Posted
: May 28, 2010
Results First Posted
: December 30, 2014
Last Update Posted
: December 30, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Volunteers | Drug: Insulin lispro A Drug: Insulin lispro B | Phase 1 |
The 2 formulations of insulin lispro will be referred to here as:
Lispro A
Lispro B
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 41 participants |
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 |
Study Start Date : | May 2010 |
Actual Primary Completion Date : | August 2010 |
Actual Study Completion Date : | August 2010 |
Arm | Intervention/treatment |
---|---|
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
|
- 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.
- 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.

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

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
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 |
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 |
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 Posted: | May 28, 2010 Key Record Dates |
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 |