- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03341299
A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 1 Diabetes Mellitus
May 12, 2020 updated by: Eli Lilly and Company
A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog® in Patients With T1DM
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 there will be approximately 12 weeks from screening to final study follow up.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Mainz, Germany
- 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.
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Neuss, Germany
- 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.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Are male or female participants with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
- Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 35.0 kg/m²
- Have a glycated hemoglobin (HbA1c) ≤9.0% at screening
- Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn [NPH] insulin, insulin glargine or insulin detemir) for at least 3 months before screening with a total insulin dose demand of less than or equal to (≤) 1.5 units per kilogram per day (U/kg/day)
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: LY900014 Before Meal
Individualized dose of LY900014 administered subcutaneously (SC) immediately before meal in one of four study periods.
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Administered SC
Other Names:
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Experimental: LY900014 After Meal
Individualized dose of LY900014 administered SC 20 minutes after start of meal in one of four study periods.
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Administered SC
Other Names:
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Active Comparator: Insulin Lispro (Humalog) Before Meal
Individualized dose of insulin lispro administered SC immediately before meal in one of four study periods.
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Administered SC
Other Names:
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Active Comparator: Insulin Lispro (Humalog) After Meal
Individualized dose of insulin lispro administered SC 20 minutes after start of meal in one of four study periods.
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Administered SC
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC)
Time Frame: Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, and 420 minutes (7 hours)
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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 .
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Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, and 420 minutes (7 hours)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve
Time Frame: Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose
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GD: Area Under The Baseline Subtracted Glucose Concentration Curve for Each Treatment Arm
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Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 13, 2017
Primary Completion (Actual)
April 3, 2018
Study Completion (Actual)
April 3, 2018
Study Registration Dates
First Submitted
November 9, 2017
First Submitted That Met QC Criteria
November 9, 2017
First Posted (Actual)
November 14, 2017
Study Record Updates
Last Update Posted (Actual)
May 14, 2020
Last Update Submitted That Met QC Criteria
May 12, 2020
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16641
- I8B-MC-ITRV (Other Identifier: Eli Lilly and Company)
- 2017-001500-30 (EudraCT Number)
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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