A Study of LY900014 in Participants With Type 1 Diabetes on Insulin Injection Therapy
Pharmacokinetics, Glucodynamics, Safety, and Tolerability of LY900014 in Patients With Type 1 Diabetes Mellitus on Multiple Daily Insulin Injection Therapy
3 other identifiers
interventional
30
1 country
1
Brief Summary
The study will be conducted in participants with type1 diabetes on insulin injection therapy to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will be conducted in two parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in both parts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2016
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
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 4, 2016
CompletedFirst Posted
Study publicly available on registry
March 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedResults Posted
Study results publicly available
April 28, 2020
CompletedJune 17, 2020
June 1, 2020
4 months
March 4, 2016
April 15, 2020
June 10, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part A)
PK: Insulin Lispro AUC(0-5h) (Part A)
Day 1: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, 300 minutes post dose for each treatment
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part B)
PK: Insulin Lispro AUC(0-5h) (Part B)
Days 1 and 14: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, 300 minutes post dose for each treatment
Secondary Outcomes (2)
Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) (Part A)
Day 1: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, 300 minutes
Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) (Part B)
Days 1 and 14: Day 1: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, 300 minutes in each study period
Study Arms (4)
LY900014 - Test (Part A)
EXPERIMENTALIndividualized doses of LY900014 administered by injection under the skin once in each of 3 periods
Insulin Lispro - Reference (Part A)
ACTIVE COMPARATORIndividualized doses of insulin lispro reference formulation administered by injection under the skin once in each of 3 periods
LY900014 - Test (Part B)
EXPERIMENTALIndividualized doses of LY900014 administered by injection under the skin immediately before each meal for 14 days
Insulin Lispro - Reference (Part B)
ACTIVE COMPARATORIndividualized doses of insulin lispro reference formulation administered by injection under the skin immediately before each meal for 14 days
Interventions
Administered subcutaneously (SC)
Administered SC
Eligibility Criteria
You may qualify if:
- Are male or female participants with Type 1 Diabetes Mellitus (T1DM) on a stable multiple daily injection regimen with a short-acting as well as a long-acting insulin
- Have a body mass index (BMI) ranging from 18.5 to 33.0 kilogram per square meter (kg/m²), inclusive, at screening
- Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results acceptable for the study
- Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party)
- Have venous access sufficient to allow for blood sampling
- Have provided written consent and are willing to follow study procedures and commit to the study duration
You may not qualify if:
- Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research judged to be incompatible with this study
- Have previously completed or withdrawn from this study
- Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
- Had blood loss of more than 500 milliliters (mL) within the last month
- Are treated with a continuous subcutaneous insulin infusion (insulin pump)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
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.
Mainz, 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 4, 2016
First Posted
March 9, 2016
Study Start
March 1, 2016
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
June 17, 2020
Results First Posted
April 28, 2020
Record last verified: 2020-06