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Completed

NCT Number: NCT01871493

A Study of LY2605541 and Insulin Lispro Mixture in Healthy Participants

The main purpose of this study is to evaluate how the body absorbs and removes LY2605541, insulin lispro, and a mixture of both from the blood. The study has two parts. Participants may enroll in only one part. Each part has four treatment periods in a fixed order. The study will last approximately 8 weeks, not including screening. Screening is required within 28 days prior to the start of the study.

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Key information

Conditions

Healthy Volunteers

Age range

21 year–65 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 not of child-bearing potential
  • Have a body mass index (BMI) between 18 and 29.9 kilograms per meter squared (kg/m^2), inclusive
  • Are nonsmokers or have not smoked for at least 2 months prior to entering the study

Exclusion criteria

  • Have known allergies to insulin or its excipients, or related drugs, or history of relevant allergic reactions of any origin
  • Have a history of first-degree relatives known to have diabetes mellitus
  • Have used systemic glucocorticoids within 3 months prior to entry into the study
  • Have donated blood or had a blood loss of 450 milliliter (mL) within 1 month prior to study enrollment

Treatment and study plan

LY2605541

Drug

Administered subcutaneous (SQ)

Insulin Lispro

Drug

Administered SQ

Other names: Humalog

Primary outcomes

  1. Pharmacokinetics (PK): Time to Reach Peak Concentration (tmax) of LY2605541 and Insulin Lispro

    Time frame: Pre-dose up to 216 hours post-dose

  2. Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY2605541 and Insulin Lispro

    Time frame: Pre-dose up to 216 hours post-dose

  3. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-∞) of LY2605541 and Insulin Lispro

    Time frame: Pre-dose up to 216 hours post-dose

Secondary outcomes

  1. Maximum Glucose Infusion Rate (Rmax)

    Time frame: Predose up to 32 hours post clamp procedure in all treatment periods

  2. Total Glucose Infused Over Clamp Duration (Gtot)

    Time frame: Predose up to 32 hours post clamp procedure in all treatment periods

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1 Study to Evaluate the Pharmacokinetics of LY2605541 Injection and Insulin Lispro Injection Administered as Mixture or as Individual Components in Healthy Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 6, 2013
Registry last updated
Oct 21, 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.

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