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A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 1 Diabetes Mellitus

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: NCT03341299
Recruitment Status : Completed
First Posted : November 14, 2017
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014, and the effect of LY900014 on blood sugar levels following a standard meal. For each participant, the study will consist of 4 periods and there will be approximately 12 weeks from screening to final study follow up.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Biological: LY900014 Biological: Insulin Lispro Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog® in Patients With T1DM
Actual Study Start Date : November 13, 2017
Actual Primary Completion Date : April 3, 2018
Actual Study Completion Date : April 3, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: LY900014 Before Meal
Individualized dose of LY900014 administered subcutaneously (SC) immediately before meal in one of four study periods.
Biological: LY900014
Administered SC

Experimental: LY900014 After Meal
Individualized dose of LY900014 administered SC 20 minutes after start of meal in one of four study periods.
Biological: LY900014
Administered SC

Active Comparator: Insulin Lispro (Humalog) Before Meal
Individualized dose of insulin lispro administered SC immediately before meal in one of four study periods.
Biological: Insulin Lispro
Administered SC
Other Names:
  • LY275585
  • Humalog

Active Comparator: Insulin Lispro (Humalog) After Meal
Individualized dose of insulin lispro administered SC 20 minutes after start of meal in one of four study periods.
Biological: Insulin Lispro
Administered SC
Other Names:
  • LY275585
  • Humalog




Primary Outcome Measures :
  1. Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) for Each Treatment Arm [ Time Frame: 0 to 420 minutes after dose of study drug in each study treatment ]
    PK: Insulin Lispro AUC for Each Treatment Arm


Secondary Outcome Measures :
  1. Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve for Each Treatment Arm [ Time Frame: 0 to 300 minutes with respect to start of test meal for each injection-to-meal timing and study treatment ]
    GD: Area Under The Baseline Subtracted Glucose Concentration Curve for Each Treatment Arm



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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:

  • Are male or female participants with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
  • Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 35.0 kg/m²
  • Have a glycated hemoglobin (HbA1c) ≤9.0% at screening
  • Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn [NPH] insulin, insulin glargine or insulin detemir) for at least 3 months before screening with a total insulin dose demand of less than or equal to (≤) 1.5 units per kilogram per day (U/kg/day)

Exclusion Criteria:

  • Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research
  • Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
  • Have donated blood of more than 450 millilitre (mL) or more in the last 3 months or provided any blood donation within the last month before screening.
  • Any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening as assessed by the investigator.
  • Are treated with a CSII (insulin pump)

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): NCT03341299


Locations
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Germany
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.
Mainz, Germany
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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03341299     History of Changes
Other Study ID Numbers: 16641
I8B-MC-ITRV ( Other Identifier: Eli Lilly and Company )
2017-001500-30 ( EudraCT Number )
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

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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
Insulin, Globin Zinc
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs