Bioequivalence of Two Lispro Formulations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01133392
First received: May 27, 2010
Last updated: December 29, 2014
Last verified: December 2014

May 27, 2010
December 29, 2014
May 2010
August 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
area under the serum insulin concentration versus time curve from time zero to time of return to baseline [AUC0-tlast] [ Time Frame: from 0 up to 8 hours post dose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01133392 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic Parameter: Maximum Serum Insulin Concentration [Cmax] [ Time Frame: 0 to 8 hours post dose ] [ Designated as safety issue: No ]
    The maximum observed insulin lispro concentration following dosing.
  • Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax) [ Time Frame: 0 to 8 hours post dose ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Time of maximal glucose infusion rate.
  • Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot) [ Time Frame: 0 to 8 hours post dose ] [ Designated as safety issue: No ]
    The total amount of glucose infused during the euglycemic clamp procedure.
  • maximum serum insulin concentration [Cmax] for insulin lispro A versus insulin lispro B [ Time Frame: 0 to 8 hours post dose ] [ Designated as safety issue: No ]
  • maximum glucose infusion rate (Rmax) for insulin lispro A versus insulin lispro B [ Time Frame: 0 to 8 hours post dose ] [ Designated as safety issue: No ]
  • time of maximum glucose infusion rate (tRmax) for insulin lispro A versus insulin lispro B [ Time Frame: 0 to 8 hours post dose ] [ Designated as safety issue: No ]
  • total amount of glucose infused (Gtot) for insulin lispro A versus insulin lispro B [ Time Frame: 0 to 8 hours post dose ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Bioequivalence of Two Lispro Formulations
Evaluation of the Bioequivalence of Two Formulations of Insulin Lispro in Healthy Subjects
This study will compare how the body treats 2 different forms of insulin lispro and how they affect blood sugar levels.

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

Lispro A

Lispro B

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Volunteers
  • Drug: Insulin lispro A
    20 units (U) subcutaneously (SC).
    Other Name: LY275585
  • Drug: Insulin lispro B
    20 U subcutaneously (SC).
    Other Name: LY275585
  • Experimental: Insulin Lispro A
    20 units (U) subcutaneously (SC)
    Intervention: Drug: Insulin lispro A
  • Active Comparator: Insulin lispro B
    20 units (U) subcutaneously (SC)
    Intervention: Drug: Insulin lispro B
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
August 2010
August 2010   (final data collection date for primary outcome measure)

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.
Both
21 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01133392
13300, F3Z-EW-IOPY
No
Not Provided
Not Provided
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP