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
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 45
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 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
Active Comparator: insulin lispro B 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

Detailed Description:

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

Lispro A

Lispro B

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT01133392     History of Changes
Other Study ID Numbers: 13300, F3Z-EW-IOPY
Study First Received: May 27, 2010
Last Updated: September 8, 2010
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Eli Lilly and Company:
insulin
lispro

Additional relevant MeSH terms:
Insulin LISPRO
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014