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A Study of LY900014 Formulation in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02942654
Recruitment Status : Completed
First Posted : October 24, 2016
Results First Posted : April 27, 2020
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE October 21, 2016
First Posted Date  ICMJE October 24, 2016
Results First Submitted Date  ICMJE April 15, 2020
Results First Posted Date  ICMJE April 27, 2020
Last Update Posted Date April 27, 2020
Study Start Date  ICMJE November 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2020)		 Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours]) [ Time Frame: Predose (0), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 210, 240, 300, 330, 360, 420, and 480 minutes, post dose ]
Area Under the Concentration Versus Time Curve (AUC) was measured from time zero to 8 hours (AUC[0-8 Hours]).
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2016)		 Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY900014 [ Time Frame: Predose through 8 hours postdose on Day 1 in each study arm ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2020)		 Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) [ Time Frame: 2.5 minutes for the first 30 minutes, then every 5 minutes until 120 minutes postdose, and then every 10 minutes until 480 minutes postdose ]
Gtot is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY900014 or Insulin Lispro by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2016)		 Total Amount of Glucose Infused (Gtot) [ Time Frame: Predose through 8 hours postdose on Day 1 in each study arm ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY900014 Formulation in Healthy Participants
Official Title  ICMJE Pharmacokinetics and Glucodynamics of LY900014 Compared to Insulin Lispro Following Single-Dose Administration in Healthy Subjects
Brief Summary This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is administered by injection under the skin of the abdomen. The study will be conducted in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of different doses of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will last about 6 to 7 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: LY900014
    Administered subcutaneously (SC)
    Other Name: Ultra-Rapid Lispro
  • Drug: Insulin Lispro
    Administered SC
Study Arms  ICMJE
  • Experimental: LY900014
    Test formulation. 15-U dose of LY900014 administered subcutaneously (SC) in one of two periods.
    Intervention: Drug: LY900014
  • Active Comparator: Insulin Lispro
    Reference formulation. 15-U dose of Insulin Lispro administered SC in one of two periods.
    Intervention: Drug: Insulin Lispro
Publications * Leohr J, Dellva MA, Carter K, LaBell E, Linnebjerg H. Ultra Rapid Lispro (URLi) Accelerates Insulin Lispro Absorption and Insulin Action vs Humalog(R) Consistently Across Study Populations: A Pooled Analysis of Pharmacokinetic and Glucodynamic Data. Clin Pharmacokinet. 2021 Nov;60(11):1423-1434. doi: 10.1007/s40262-021-01030-0. Epub 2021 May 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2016)		 32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until study completion)
  • Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²), inclusive, at screening
  • Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
  • Are nonsmokers, have not smoked for at least 2 months prior to entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study

Exclusion Criteria:

  • Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
  • Have previously participated or withdrawn from this study
  • Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
  • Had blood loss of more than 450 milliliters (mL) within the last month
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02942654
Other Study ID Numbers  ICMJE 16170
I8B-MC-ITRL ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Eli Lilly and Company
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eli Lilly and Company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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
PRS Account Eli Lilly and Company
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP