Back to resultsA Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps
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:
- Male or female participants with type 1 diabetes
- Body mass index (BMI) between 18.5 and 30.0 kilograms per square meter, inclusive
- Hemoglobin A1c (HbA1c) less than or equal to 8.5 percent (%)
- Using CSII and stable insulin regimen for at least 3 months prior to inclusion into the trial
Exclusion Criteria:
- Known or suspected hypersensitivity to investigational medical product(s) or related products
- Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomization in this trial
- Known slowing of gastric emptying and or gastrointestinal surgery that, in the opinion of the investigator, might change gastrointestinal motility and food absorption
- Proliferative retinopathy or maculopathy as judged by the Investigator based on a recent (less than 1.5 years) ophthalmologic examination
- Widespread subcutaneous lipodystrophy in the abdomen
- Current use of any glucose-lowering agents other than insulin within 3 months prior to screening
- Chronic or recent use of corticosteroids
Sites / Locations
- Profil Mainz GmbH & Co. KG
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
100 U/mL LY900014
100 U/mL Insulin Lispro (Humalog)
Arm Description
100 units per milliliter (U/mL) LY900014 administered by continuous subcutaneous insulin infusion (CSII) in one of two study periods.
100 U/mL Insulin Lispro (Humalog) administered by CSII in one of two study periods.
Outcomes
Primary Outcome Measures
Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Missed Meal Bolus
Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 Milligrams per deciliter (mg/dL).
Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Pump Suspension
Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 mg/dL.
Secondary Outcome Measures
Pharmacodynamics (PD): Maximum Observed Plasma Glucose (PGmax) Following Administration of LY900014 and Insulin Lispro (Humalog)
PD: PGmax following administration of LY900014 and insulin lispro (Humalog)
Pharmacokinetics (PK): Time to Maximum Observed Insulin Lispro Concentration (Tmax) Following Administration of LY900014 and Insulin Lispro (Humalog)
PK: Tmax following administration of LY900014 and insulin lispro (Humalog)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04276207
Brief Title
A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps
Official Title
Effects of LY900014 on Recovery From Hyperglycemia Compared to Humalog in Subjects With Type 1 Diabetes Mellitus (T1DM) on Continuous Subcutaneous Insulin Infusion
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 25, 2020 (Actual)
Primary Completion Date
August 10, 2020 (Actual)
Study Completion Date
August 10, 2020 (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 main purpose of this study is to compare LY900014 to insulin lispro (Humalog) in participants with type 1 diabetes who are using an insulin pump and have high blood sugar after eating. For each participant, the study will last about two to nine weeks.
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
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
100 U/mL LY900014
Arm Type
Experimental
Arm Description
100 units per milliliter (U/mL) LY900014 administered by continuous subcutaneous insulin infusion (CSII) in one of two study periods.
Arm Title
100 U/mL Insulin Lispro (Humalog)
Arm Type
Active Comparator
Arm Description
100 U/mL Insulin Lispro (Humalog) administered by CSII in one of two study periods.
Intervention Type
Drug
Intervention Name(s)
LY900014
Intervention Description
Administered by CSII
Intervention Type
Drug
Intervention Name(s)
Insulin Lispro
Other Intervention Name(s)
Humalog, LY275585
Intervention Description
Administered by CSII
Primary Outcome Measure Information:
Title
Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Missed Meal Bolus
Description
Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 Milligrams per deciliter (mg/dL).
Time Frame
Day 1: Baseline up to 5 hours after missed meal bolus
Title
Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Pump Suspension
Description
Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 mg/dL.
Time Frame
Day 2: Baseline up to 5 hours after pump suspension
Secondary Outcome Measure Information:
Title
Pharmacodynamics (PD): Maximum Observed Plasma Glucose (PGmax) Following Administration of LY900014 and Insulin Lispro (Humalog)
Description
PD: PGmax following administration of LY900014 and insulin lispro (Humalog)
Time Frame
Day 1: Baseline up to 5 hours after missed meal bolus and Day 2: Baseline up to 5 hours after pump suspension
Title
Pharmacokinetics (PK): Time to Maximum Observed Insulin Lispro Concentration (Tmax) Following Administration of LY900014 and Insulin Lispro (Humalog)
Description
PK: Tmax following administration of LY900014 and insulin lispro (Humalog)
Time Frame
Day 1: Baseline up to 5 hours after missed meal bolus and Day 2: Baseline up to 5 hours after pump suspension
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female participants with type 1 diabetes
Body mass index (BMI) between 18.5 and 30.0 kilograms per square meter, inclusive
Hemoglobin A1c (HbA1c) less than or equal to 8.5 percent (%)
Using CSII and stable insulin regimen for at least 3 months prior to inclusion into the trial
Exclusion Criteria:
Known or suspected hypersensitivity to investigational medical product(s) or related products
Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomization in this trial
Known slowing of gastric emptying and or gastrointestinal surgery that, in the opinion of the investigator, might change gastrointestinal motility and food absorption
Proliferative retinopathy or maculopathy as judged by the Investigator based on a recent (less than 1.5 years) ophthalmologic examination
Widespread subcutaneous lipodystrophy in the abdomen
Current use of any glucose-lowering agents other than insulin within 3 months prior to screening
Chronic or recent use of corticosteroids
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
Profil Mainz GmbH & Co. KG
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55116
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps
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