A Study of LY900027 Given by Insulin Pump to Participants With Type 1 Diabetes Mellitus
A Study to Assess the Pharmacokinetics, Glucodynamics, Safety, and Tolerability of LY900027 in Patients With Type 1 Diabetes Mellitus on Continuous Subcutaneous Insulin Infusion Therapy
3 other identifiers
interventional
20
1 country
1
Brief Summary
The main purpose of this study is to learn more about a new formulation of insulin lispro when given by an insulin pump to participants with type 1 diabetes mellitus. The study will investigate how the body processes the drug and how the drug affects the body. Information about side effects will be collected. The study will last from six to 12 weeks for each participant.
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 Dec 2019
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
November 12, 2019
CompletedFirst Posted
Study publicly available on registry
November 13, 2019
CompletedStudy Start
First participant enrolled
December 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 14, 2020
CompletedAugust 5, 2020
August 1, 2020
7 months
November 12, 2019
August 4, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Pharmacokinetics (PK): Pharmacokinetics (PK): Area Under the Insulin Lispro Curve (AUC) 0 to 5 hours after Bolus Administration Prior to a Mixed Meal Tolerance Text (MMTT)
PK: AUC after Bolus Administration Prior to a MMTT
Day 1 through Day 10 in each dosing period
PK: Maximum Observed Insulin Lispro Concentration (Cmax)
PK: C PK: Cmax
Day 1 through Day 10 in each dosing period
Secondary Outcomes (3)
Pharmacodynamics (PD): Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion
Day 1 through Day 10 in each dosing period
PD: Total Daily Insulin Dose
Day 1 through Day 10 in each dosing period
Duration Until Catheter Failure
Day -1 through Day 10 in each dosing period
Study Arms (2)
LY900027
EXPERIMENTALLY900027 administered to participants with type 1 diabetes mellitus (T1DM) using continuous subcutaneous insulin infusion (CSII) in one of two dosing periods.
Insulin Lispro
ACTIVE COMPARATORInsulin lispro administered to participants with T1DM using CSII in one of two dosing periods.
Interventions
Insulin lispro administered to participants with T1DM using CSII.
Eligibility Criteria
You may qualify if:
- Diagnosis of T1DM for at least 1 year
- Fasting C-peptide ≤0.30 nanomoles per liter (nmol/L)
- Bbody mass index between 18.5 and 33.0 kilograms per square meter (kg/m²)
- Participants should have a glycated hemoglobin of ≤9.0% at screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Profil Institut für Stoffwechselforschung
Neuss, North Rhine-Westphalia, 41460, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
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
November 12, 2019
First Posted
November 13, 2019
Study Start
December 27, 2019
Primary Completion
July 14, 2020
Study Completion
July 14, 2020
Last Updated
August 5, 2020
Record last verified: 2020-08-01
Data Sharing
- IPD Sharing
- Will not share