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Completed

NCT Number: NCT02111083

A Study of 2 Different Formulations of Insulin Lispro in Healthy Participants

The study involves 4 injections of insulin lispro and its purpose is to:

* Determine if 2 formulations of insulin lispro are treated by the body in a similar way. * Compare how the 2 formulations of insulin lispro affect blood sugar level. * Determine the safety of each insulin lispro formulations and any side effects that might be associated with them when given to healthy participants. The study is expected to last up to approximately 9 weeks for each participant.

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Key information

Conditions

Healthy Volunteers

Age range

18 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, 117597

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 kilogram 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 (fasting blood glucose [FBG], plasma) >6 millimoles per liter (mmol/L) at screening
  • Have positive hepatitis B surface antigen.

Treatment and study plan

Insulin Lispro

Biological

LY275585 administered SC.

Primary outcomes

  1. Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Zero to Time of Return to Baseline (AUC0-tlast)

    Time frame: Day 1, predose through 8 hours post dose in each period.

  2. Pharmacokinetic Parameter: Maximum Serum Insulin Concentration (Cmax)

    Time frame: Day 1, predose through 8 hours post dose in each period

  3. Pharmacokinetic Parameter: Area Under the Curve(AUC)

    Time frame: Zero to infinity [AUC(0-∞)]

Secondary outcomes

  1. Pharmacokinetic Parameter: Time of Maximum Observed Serum Concentration (Tmax)

    Time frame: Day 1, predose through 8 hours post dose in each period.

  2. Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)

    Time frame: Day1, predose through 8 hours post dose in each period.

    The total amount of glucose infused during the euglycemic clamp procedure.

  3. Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)

    Time frame: Day 1, predose through 8 hours post dose in each period.

    The maximum observed glucose infusion rate during the euglycemic clamp procedure.

  4. Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)

    Time frame: Day 1, predose through 8 hours post dose in each period.

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
2014
Primary completion
2014
Study completion
2014
First posted
Apr 10, 2014
Registry last updated
May 21, 2015

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.

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