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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
LY900014
Insulin Lispro
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • 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.
  • 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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

LY900014 Before Meal

LY900014 After Meal

Insulin Lispro (Humalog) Before Meal

Insulin Lispro (Humalog) After Meal

Arm Description

Individualized dose of LY900014 administered subcutaneously (SC) immediately before meal in one of four study periods.

Individualized dose of LY900014 administered SC 20 minutes after start of meal in one of four study periods.

Individualized dose of insulin lispro administered SC immediately before meal in one of four study periods.

Individualized dose of insulin lispro administered SC 20 minutes after start of meal in one of four study periods.

Outcomes

Primary Outcome Measures

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC)
PK: Insulin Lispro AUC for Each Treatment Arm. LY900014 before and after meal and insulin lispro (Humalog) before and after meal were pooled by treatment to evaluate the overall PK of LY900014 and insulin lispro (Humalog) per protocol .

Secondary Outcome Measures

Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve
GD: Area Under The Baseline Subtracted Glucose Concentration Curve for Each Treatment Arm

Full Information

First Posted
November 9, 2017
Last Updated
May 12, 2020
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03341299
Brief Title
A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 1 Diabetes Mellitus
Official Title
A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog® in Patients With T1DM
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 13, 2017 (Actual)
Primary Completion Date
April 3, 2018 (Actual)
Study Completion Date
April 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY900014 Before Meal
Arm Type
Experimental
Arm Description
Individualized dose of LY900014 administered subcutaneously (SC) immediately before meal in one of four study periods.
Arm Title
LY900014 After Meal
Arm Type
Experimental
Arm Description
Individualized dose of LY900014 administered SC 20 minutes after start of meal in one of four study periods.
Arm Title
Insulin Lispro (Humalog) Before Meal
Arm Type
Active Comparator
Arm Description
Individualized dose of insulin lispro administered SC immediately before meal in one of four study periods.
Arm Title
Insulin Lispro (Humalog) After Meal
Arm Type
Active Comparator
Arm Description
Individualized dose of insulin lispro administered SC 20 minutes after start of meal in one of four study periods.
Intervention Type
Biological
Intervention Name(s)
LY900014
Other Intervention Name(s)
Ultra-Rapid Lispro
Intervention Description
Administered SC
Intervention Type
Biological
Intervention Name(s)
Insulin Lispro
Other Intervention Name(s)
LY275585, Humalog
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC)
Description
PK: Insulin Lispro AUC for Each Treatment Arm. LY900014 before and after meal and insulin lispro (Humalog) before and after meal were pooled by treatment to evaluate the overall PK of LY900014 and insulin lispro (Humalog) per protocol .
Time Frame
Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, and 420 minutes (7 hours)
Secondary Outcome Measure Information:
Title
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve
Description
GD: Area Under The Baseline Subtracted Glucose Concentration Curve for Each Treatment Arm
Time Frame
Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Mainz
Country
Germany
Facility Name
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.
City
Neuss
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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