A Study of LY2605541 and Insulin Lispro Mixture in Healthy Participants

NCT01871493 | Completed Phase 1

• 2 other identifiers: 14833I6O-FW-BHBA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

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

  Pre-dose up to 216 hours post-dose

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

  Pre-dose up to 216 hours post-dose

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

  Pre-dose up to 216 hours post-dose

Secondary Outcomes (2)

• Maximum Glucose Infusion Rate (Rmax)

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

• Total Glucose Infused Over Clamp Duration (Gtot)

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

Study Arms (8)

LY2605541-Part A

EXPERIMENTAL

1.42 units per kilogram (U/kg) of LY2605541 given once daily (QD) for 1 day, subcutaneously (SQ) in 1 of 4 treatment periods.

Drug: LY2605541

Insulin Lispro-Part A

ACTIVE COMPARATOR

Single dose 0.36 U/kg of insulin lispro given QD for 1 day, SQ in 1 of 4 treatment periods.

Drug: Insulin Lispro

LY2605541/Lispro Mix 1-Part A

EXPERIMENTAL

Single dose 0.54 U/kg of LY2605541 and 0.36 U/kg insulin lispro mixture given QD for 1 day, SQ in 1 of 4 treatment periods.

Drug: LY2605541; Drug: Insulin Lispro

LY2605541/Lispro Mix 2-Part A

EXPERIMENTAL

Single dose 1.42 U/kg of LY2605541 and 0.36 insulin lispro mixture given QD for 1 day, SQ in 1 of 4 treatment periods.

Drug: LY2605541; Drug: Insulin Lispro

Insulin Lispro-Part B

ACTIVE COMPARATOR

0.18 U/kg insulin lispro given twice daily (BID) for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.

Drug: Insulin Lispro

LY2605541/Lispro Mix-Part B

EXPERIMENTAL

0.71 U/kg LY2605541 and 0.18 U/kg insulin lispro mixture given BID for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.

Drug: LY2605541; Drug: Insulin Lispro

LY2605541 QD-Part B

EXPERIMENTAL

0.54 U/kg of LY2605541 given QD for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.

Drug: LY2605541

LY2605541 BID-Part B

EXPERIMENTAL

0.71 U/kg of LY2605541 given BID for 1 day SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.

Drug: LY2605541

Interventions

LY2605541 DRUG

Administered subcutaneous (SQ)

LY2605541 BID-Part B; LY2605541 QD-Part B; LY2605541-Part A; LY2605541/Lispro Mix 1-Part A; LY2605541/Lispro Mix 2-Part A; LY2605541/Lispro Mix-Part B

Insulin Lispro DRUG

Administered SQ

Also known as: Humalog

Insulin Lispro-Part A; Insulin Lispro-Part B; LY2605541/Lispro Mix 1-Part A; LY2605541/Lispro Mix 2-Part A; LY2605541/Lispro Mix-Part B

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, Singapore

Location

MeSH Terms

Interventions

LY2605541; Insulin Lispro

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 6, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 21, 2014

Record last verified: 2014-10

Locations

SG (1)