Skip to main content
OpenTrials
Completed

NCT Number: NCT01133392

Bioequivalence of Two Lispro Formulations

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

About this study

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

Lispro A

Lispro B

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin lispro A

Drug

20 units (U) subcutaneously (SC).

Other names: LY275585

Insulin lispro B

Drug

20 U subcutaneously (SC).

Other names: LY275585

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Evaluation of the Bioequivalence of Two Formulations of Insulin Lispro in Healthy Subjects

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 28, 2010
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.