Back to resultsA Study of LY900014 in Participants With Type 1 Diabetes on Insulin Injection Therapy
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
LY900014
Insulin Lispro
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria:
- Are male or female participants with Type 1 Diabetes Mellitus (T1DM) on a stable multiple daily injection regimen with a short-acting as well as a long-acting insulin
- Have a body mass index (BMI) ranging from 18.5 to 33.0 kilogram per square meter (kg/m²), inclusive, at screening
- Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results acceptable for the study
- Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party)
- 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 enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research judged to be incompatible with this study
- Have previously completed or withdrawn from this study
- Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
- Had blood loss of more than 500 milliliters (mL) within the last month
- Are treated with a continuous subcutaneous insulin infusion (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.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
LY900014 - Test (Part A)
Insulin Lispro - Reference (Part A)
LY900014 - Test (Part B)
Insulin Lispro - Reference (Part B)
Arm Description
Individualized doses of LY900014 administered by injection under the skin once in each of 3 periods
Individualized doses of insulin lispro reference formulation administered by injection under the skin once in each of 3 periods
Individualized doses of LY900014 administered by injection under the skin immediately before each meal for 14 days
Individualized doses of insulin lispro reference formulation administered by injection under the skin immediately before each meal for 14 days
Outcomes
Primary Outcome Measures
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part A)
PK: Insulin Lispro AUC(0-5h) (Part A)
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part B)
PK: Insulin Lispro AUC(0-5h) (Part B)
Secondary Outcome Measures
Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) (Part A)
PD: AUC(0-5h) of Glucose Relative to a MMTT (Part A)
Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) (Part B)
PD: AUC(0-5h) of Glucose Relative to a MMTT (Part B)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02703350
Brief Title
A Study of LY900014 in Participants With Type 1 Diabetes on Insulin Injection Therapy
Official Title
Pharmacokinetics, Glucodynamics, Safety, and Tolerability of LY900014 in Patients With Type 1 Diabetes Mellitus on Multiple Daily Insulin Injection Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will be conducted in participants with type1 diabetes on insulin injection therapy to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will be conducted in two parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in both parts.
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
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY900014 - Test (Part A)
Arm Type
Experimental
Arm Description
Individualized doses of LY900014 administered by injection under the skin once in each of 3 periods
Arm Title
Insulin Lispro - Reference (Part A)
Arm Type
Active Comparator
Arm Description
Individualized doses of insulin lispro reference formulation administered by injection under the skin once in each of 3 periods
Arm Title
LY900014 - Test (Part B)
Arm Type
Experimental
Arm Description
Individualized doses of LY900014 administered by injection under the skin immediately before each meal for 14 days
Arm Title
Insulin Lispro - Reference (Part B)
Arm Type
Active Comparator
Arm Description
Individualized doses of insulin lispro reference formulation administered by injection under the skin immediately before each meal for 14 days
Intervention Type
Drug
Intervention Name(s)
LY900014
Other Intervention Name(s)
Ultra-Rapid Lispro
Intervention Description
Administered subcutaneously (SC)
Intervention Type
Drug
Intervention Name(s)
Insulin Lispro
Other Intervention Name(s)
LY275585
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part A)
Description
PK: Insulin Lispro AUC(0-5h) (Part A)
Time Frame
Day 1: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, 300 minutes post dose for each treatment
Title
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part B)
Description
PK: Insulin Lispro AUC(0-5h) (Part B)
Time Frame
Days 1 and 14: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, 300 minutes post dose for each treatment
Secondary Outcome Measure Information:
Title
Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) (Part A)
Description
PD: AUC(0-5h) of Glucose Relative to a MMTT (Part A)
Time Frame
Day 1: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, 300 minutes
Title
Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) (Part B)
Description
PD: AUC(0-5h) of Glucose Relative to a MMTT (Part B)
Time Frame
Days 1 and 14: Day 1: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, 300 minutes in each study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Are male or female participants with Type 1 Diabetes Mellitus (T1DM) on a stable multiple daily injection regimen with a short-acting as well as a long-acting insulin
Have a body mass index (BMI) ranging from 18.5 to 33.0 kilogram per square meter (kg/m²), inclusive, at screening
Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results acceptable for the study
Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party)
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 enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research judged to be incompatible with this study
Have previously completed or withdrawn from this study
Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
Had blood loss of more than 500 milliliters (mL) within the last month
Are treated with a continuous subcutaneous insulin infusion (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
12. IPD Sharing Statement
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A Study of LY900014 in Participants With Type 1 Diabetes on Insulin Injection Therapy
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