A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps
Effects of LY900014 on Recovery From Hyperglycemia Compared to Humalog in Subjects With Type 1 Diabetes Mellitus (T1DM) on Continuous Subcutaneous Insulin Infusion
3 other identifiers
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2020
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2020
CompletedFirst Posted
Study publicly available on registry
February 19, 2020
CompletedStudy Start
First participant enrolled
February 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2020
CompletedResults Posted
Study results publicly available
August 25, 2021
CompletedAugust 25, 2021
July 1, 2021
6 months
February 18, 2020
July 30, 2021
July 30, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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).
Day 1: Baseline up to 5 hours after missed meal bolus
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.
Day 2: Baseline up to 5 hours after pump suspension
Secondary Outcomes (2)
Pharmacodynamics (PD): Maximum Observed Plasma Glucose (PGmax) Following Administration of LY900014 and Insulin Lispro (Humalog)
Day 1: Baseline up to 5 hours after missed meal bolus and Day 2: Baseline up to 5 hours after pump suspension
Pharmacokinetics (PK): Time to Maximum Observed Insulin Lispro Concentration (Tmax) Following Administration of LY900014 and Insulin Lispro (Humalog)
Day 1: Baseline up to 5 hours after missed meal bolus and Day 2: Baseline up to 5 hours after pump suspension
Study Arms (2)
100 U/mL LY900014
EXPERIMENTAL100 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)
ACTIVE COMPARATOR100 U/mL Insulin Lispro (Humalog) administered by CSII in one of two study periods.
Interventions
Administered by CSII
Eligibility Criteria
You may qualify if:
- 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 (%)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Profil Mainz GmbH & Co. KG
Mainz, Rhineland-Palatinate, 55116, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2020
First Posted
February 19, 2020
Study Start
February 25, 2020
Primary Completion
August 10, 2020
Study Completion
August 10, 2020
Last Updated
August 25, 2021
Results First Posted
August 25, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share