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A Study of LY900014 Administered in Participants With Type 1 Diabetes Using an Insulin Pump

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ClinicalTrials.gov Identifier: NCT03056456
Recruitment Status : Completed
First Posted : February 17, 2017
Results First Posted : May 1, 2020
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
This study will be conducted in participants with type 1 diabetes mellitus to investigate how the human body processes LY900014, a new blood sugar lowering insulin, and its effect on blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability will be documented. The study will last about 4 to 11 weeks for each participant.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: LY900014 Drug: Insulin Lispro (Humalog) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Study to Assess the Pharmacokinetics, Glucodynamics, Safety, and Tolerability of LY900014 in Patients With Type 1 Diabetes Mellitus on Continuous Subcutaneous Insulin Infusion Therapy
Actual Study Start Date : February 23, 2017
Actual Primary Completion Date : June 19, 2017
Actual Study Completion Date : June 19, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: LY900014
LY900014 (Treatment B) delivered via an insulin pump as a continuous infusion under the skin, with various intermittent bolus doses immediately before meals over 3-days per period.
 Drug: LY900014
Administered subcutaneously (SC)
Other Name: Ultra-Rapid Lispro
Active Comparator: Insulin Lispro (Humalog)
Insulin lispro (Treatment A) delivered via an insulin pump as a continuous infusion under the skin, with various intermittent bolus doses immediately before meals over 3-days per period.
 Drug: Insulin Lispro (Humalog)
Administered SC
Other Names:
  • LY275585
  • Humalog


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours(h) (AUC [0-5 h]) Following Administration of Each Study Arm With a Standard Single-wave Bolus [ Time Frame: Days 1 and 3: -15, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes post dose ]
    PK: Insulin Lispro AUC(0-5h)

  2. Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC [0-5 h]) of Following Administration of Each Study Arm With a Standard Dual-wave Bolus [ Time Frame: Days 1 and 3: -15, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes post dose ]
    PK: Insulin Lispro AUC(0-5h)


Secondary Outcome Measures :
  1. Glucodynamics (GD): Change From Baseline Area Under the Concentration Curve From Time Zero to 5 Hours (AUC [0-5h]) of Glucose Relative to Mixed Meal Tolerance Test Following Administration of Each Study Arm With a Standard Single-wave Bolus [ Time Frame: Days 1 and 3: -30, -15, 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180,195, 210, 225, 240, and 300 minutes post dose ]
    GD: Change from baseline in AUC (0-5h) of glucose relative to mixed meal tolerance test (MMTT).

  2. Glucodynamics (GD): Change From Baseline Area Under the Concentration Curve From Time Zero to 5 Hours (AUC [0-5 h]) of Glucose Relative to MMTT Following Administration of Each Study Arm With a Standard Dual-wave Bolus [ Time Frame: Day 1 and 3: -30, -15, 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180,195, 210, 225, 240, and 300 minutes post dose ]
    GD: Change from baseline in AUC (0-5h) of glucose relative to MMTT.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female participants with Type 1 Diabetes Mellitus (T1DM) who are receiving insulin therapy via an approved insulin pump
  • Have a screening body mass index (BMI) of greater than 18.5 to 33.0 kilograms per meter squared (kg/m²), inclusive
  • Have medical and laboratory test results that are acceptable for the study
  • Have had no episodes of severe hypoglycemia (requiring assistance in treatment by a second party) in the past 6 months
  • Have venous access sufficient to allow for blood sampling
  • Have provided written consent and are willing to follow study procedures and commit to the study duration

Exclusion Criteria:

  • Are currently participating or recently participated in a clinical trial or any other type of medical research judged to be incompatible with this study
  • Had blood loss of more than 500 milliliters (mL) within the last month
  • Have known allergies to LY900014, insulin lispro, related compounds or any components in the study drug formulations
  • Have previously participated or withdrawn from this study
  • Have or used to have health problems or medical test results that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056456


Locations
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Germany
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Neuss, Germany, 41460
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Neuss, Germany
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] February 6, 2017
Statistical Analysis Plan  [PDF] February 24, 2017

More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03056456    
Other Study ID Numbers: 16727
I8B-MC-ITSC ( Other Identifier: Eli Lilly and Company )
2016-004093-18 ( EudraCT Number )
First Posted: February 17, 2017    Key Record Dates
Results First Posted: May 1, 2020
Last Update Posted: May 1, 2020
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs