Back to resultsA Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 2 Diabetes Mellitus (T2DM)
Primary Purpose
Diabetes Mellitus, Type 2
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 2
Eligibility Criteria
Inclusion Criteria:
- Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 40.0 kg/m²
- Have a glycated hemoglobin (HbA1c) less than or equal to (≤)9.0%
- Have a fasting C-peptide ≤1.0 nanomole per liter (nmol/L)
- Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn [NPH] insulin, insulin glargine or insulin detemir) with or without a stable dose of metformin for at least 3 months before screening
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)
- Require daily insulin treatment greater than (>)1.2 units per kilogram per body weight (U/kg/body weight)
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 Zero to Seven Hours (AUC0-7hr)
PK: Insulin Lispro AUC for Each Treatment Arm. 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 (BGΔAUC) for Each Treatment Arm
GD: Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) for Each Treatment Arm
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03341312
Brief Title
A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 2 Diabetes Mellitus (T2DM)
Official Title
A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog® in Patients With T2DM
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
March 31, 2018 (Actual)
Study Completion Date
March 31, 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 will last 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 2
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 Zero to Seven Hours (AUC0-7hr)
Description
PK: Insulin Lispro AUC for Each Treatment Arm. 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, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes (7 hours) postdose
Secondary Outcome Measure Information:
Title
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) for Each Treatment Arm
Description
GD: Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) for Each Treatment Arm
Time Frame
-30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, and 300 minutes post-meal
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:
Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 40.0 kg/m²
Have a glycated hemoglobin (HbA1c) less than or equal to (≤)9.0%
Have a fasting C-peptide ≤1.0 nanomole per liter (nmol/L)
Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn [NPH] insulin, insulin glargine or insulin detemir) with or without a stable dose of metformin for at least 3 months before screening
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)
Require daily insulin treatment greater than (>)1.2 units per kilogram per body weight (U/kg/body weight)
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
Plan to Share IPD
No
Learn more about this trial
A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 2 Diabetes Mellitus (T2DM)
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