A Study of LY900014 in Participants With Type 1 Diabetes Mellitus
A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog in Children, Adolescents, and Adults With Type 1 Diabetes Mellitus
3 other identifiers
interventional
56
2 countries
2
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.
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 Mar 2018
2 active sites
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
March 9, 2018
CompletedFirst Posted
Study publicly available on registry
March 14, 2018
CompletedStudy Start
First participant enrolled
March 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2019
CompletedResults Posted
Study results publicly available
June 18, 2020
CompletedJune 18, 2020
December 1, 2019
1.6 years
March 9, 2018
May 5, 2020
June 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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 Outcomes (1)
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part
-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
Study Arms (4)
LY900014-Part A
EXPERIMENTALParticipants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014.
Humalog (Insulin Lispro)-Part A
ACTIVE COMPARATORParticipants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL of Humalog.
LY900014-Part B
EXPERIMENTALParticipants 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.
Humalog (Insulin Lispro)-Part B
ACTIVE COMPARATORParticipants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.
Interventions
Administered via SC injection
Administered via SC injection
Eligibility Criteria
You may qualify if:
- 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 (%)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
LMC Endocrinology Centres Ltd.
Toronto, Ontario, M4G 3E8, Canada
Kinderkrankenhaus auf der Bult
Hanover, Lower Saxony, 30173, Germany
Related Links
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
March 9, 2018
First Posted
March 14, 2018
Study Start
March 26, 2018
Primary Completion
November 14, 2019
Study Completion
November 14, 2019
Last Updated
June 18, 2020
Results First Posted
June 18, 2020
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share