Back to resultsA Study of LY900014 in Participants With Type 1 Diabetes Mellitus
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LY900014
Insulin Lispro
Sponsored by
About this trial
This is an interventional basic science trial for Type 1 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Are male or female participants aged 6-64 with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
- Have a glycated hemoglobin (HbA1c) less than (<)10.0 percent (%)
Exclusion Criteria:
- Receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 12 months prior to screening
- More than one episode of severe hypoglycaemia in the last 6 months
- Presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, proliferative retinopathy, uncontrolled celiac disease, uncontrolled hyperthyroidism or hypothyroidism, or adrenal insufficiency
- Have obvious clinical signs or symptoms of liver disease
- Have a history of renal impairment
Sites / Locations
- LMC Endocrinology Centres Ltd.
- Kinderkrankenhaus auf der Bult
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
LY900014-Part A
Humalog (Insulin Lispro)-Part A
LY900014-Part B
Humalog (Insulin Lispro)-Part B
Arm Description
Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014.
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL of Humalog.
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the continuous subcutaneous insulin infusion (CSII) pump.
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
Outcomes
Primary Outcome Measures
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) Following Each Treatment Arm for Each Study Part
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC(0 -7h)) following Each Treatment Arm for Each Study Part.
Secondary Outcome Measures
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve (BG∆AUC(0-5h)) Following Each Treatment Arm for Each Study Part.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03465878
Brief Title
A Study of LY900014 in Participants With Type 1 Diabetes Mellitus
Official Title
A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog in Children, Adolescents, and Adults With Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 26, 2018 (Actual)
Primary Completion Date
November 14, 2019 (Actual)
Study Completion Date
November 14, 2019 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in participants with type 1 diabetes mellitus.
There are 2 parts to this study. Part A is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by subcutaneous injection. Part B of the study is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by continuous subcutaneous insulin infusion (CSII) pump.
Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 40 days in each part.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY900014-Part A
Arm Type
Experimental
Arm Description
Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014.
Arm Title
Humalog (Insulin Lispro)-Part A
Arm Type
Active Comparator
Arm Description
Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL of Humalog.
Arm Title
LY900014-Part B
Arm Type
Experimental
Arm Description
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the continuous subcutaneous insulin infusion (CSII) pump.
Arm Title
Humalog (Insulin Lispro)-Part B
Arm Type
Active Comparator
Arm Description
Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
Intervention Type
Drug
Intervention Name(s)
LY900014
Other Intervention Name(s)
Ultra-Rapid Lispro
Intervention Description
Administered via SC injection
Intervention Type
Drug
Intervention Name(s)
Insulin Lispro
Other Intervention Name(s)
Humalog, LY275585
Intervention Description
Administered via SC injection
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) Following Each Treatment Arm for Each Study Part
Description
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC(0 -7h)) following Each Treatment Arm for Each Study Part.
Time Frame
Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes postdose
Secondary Outcome Measure Information:
Title
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part
Description
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve (BG∆AUC(0-5h)) Following Each Treatment Arm for Each Study Part.
Time Frame
-30, -15, 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240 and 300 minutes postdose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Are male or female participants aged 6-64 with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
Have a glycated hemoglobin (HbA1c) less than (<)10.0 percent (%)
Exclusion Criteria:
Receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 12 months prior to screening
More than one episode of severe hypoglycaemia in the last 6 months
Presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, proliferative retinopathy, uncontrolled celiac disease, uncontrolled hyperthyroidism or hypothyroidism, or adrenal insufficiency
Have obvious clinical signs or symptoms of liver disease
Have a history of renal impairment
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
LMC Endocrinology Centres Ltd.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
Kinderkrankenhaus auf der Bult
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30173
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.lillytrialguide.com/en-US/studies/type-1-diabetes/ITSA#?postal=
Description
A Study of LY900014 in Participants With Type 1 Diabetes Mellitus
Learn more about this trial
A Study of LY900014 in Participants With Type 1 Diabetes Mellitus
We'll reach out to this number within 24 hrs