Bioequivalence of Two Lispro Formulations

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01133392
First received: May 27, 2010
Last updated: September 8, 2010
Last verified: September 2010

May 27, 2010
September 8, 2010
May 2010
August 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01133392 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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 U will be administered subcutaneously. Two doses of insulin lispro A will be administered 8 to 14 days apart
    Other Name: LY275585
  • Drug: insulin lispro B
    20 U will be administered subcutaneously. Two doses of insulin lispro B will be administered 8 to 14 days apart.
    Other Name: LY275585
  • Experimental: insulin lispro A
    Intervention: Drug: insulin lispro A
  • Active Comparator: insulin lispro B
    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
45
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 kg/m2
  • Are nonsmokers.
  • Have normal blood pressure and pulse rate, a normal 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 mmol/L at screening.
  • Have positive hepatitis B surface antigen.
Both
21 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01133392
13300, F3Z-EW-IOPY
No
Chief Medical Officer, Eli Lilly
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
September 2010

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