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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
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Insulin lispro A Drug: Insulin lispro B Phase 1

Detailed Description:

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

Lispro A

Lispro B


Study Design
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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

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U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Pharmacokinetic Parameter: Maximum Serum Insulin Concentration [Cmax] [ Time Frame: 0 to 8 hours post dose ]
    The maximum observed insulin lispro concentration following dosing.

  2. 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.

  3. Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax) [ Time Frame: 0 to 8 hours post dose ]
    Time of maximal glucose infusion rate.

  4. 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.


Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 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