Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.
Enrollment: 41
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
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

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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01133392     History of Changes
Other Study ID Numbers: 13300, F3Z-EW-IOPY
Study First Received: May 27, 2010
Results First Received: October 10, 2014
Last Updated: December 29, 2014
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Eli Lilly and Company:
insulin
lispro

Additional relevant MeSH terms:
Insulin
Insulin Lispro
Insulin, Globin Zinc
 Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 02, 2015