A Study of LY2605541 and Insulin Lispro Mixture in Healthy Participants
- Registration Number
- NCT01871493
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LY2605541-Part A LY2605541 1.42 units per kilogram (U/kg) of LY2605541 given once daily (QD) for 1 day, subcutaneously (SQ) in 1 of 4 treatment periods. LY2605541 QD-Part B LY2605541 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. LY2605541/Lispro Mix 1-Part A LY2605541 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. LY2605541/Lispro Mix 2-Part A LY2605541 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. LY2605541/Lispro Mix-Part B LY2605541 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. LY2605541 BID-Part B LY2605541 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. Insulin Lispro-Part A Insulin Lispro Single dose 0.36 U/kg of insulin lispro given QD for 1 day, SQ in 1 of 4 treatment periods. LY2605541/Lispro Mix 1-Part A Insulin Lispro 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. LY2605541/Lispro Mix 2-Part A Insulin Lispro 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. Insulin Lispro-Part B Insulin Lispro 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. LY2605541/Lispro Mix-Part B Insulin Lispro 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.
- Primary Outcome Measures
Name Time Method Pharmacokinetics (PK): Time to Reach Peak Concentration (tmax) 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 Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY2605541 and Insulin Lispro Pre-dose up to 216 hours post-dose
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (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, Singapore