A study of LY900014 compared to Humalog in children, adolescents and adults 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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003220-78-DE

Enrollment

Registered

2017-10-26

Start date

Unknown

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1 MedDRA version: 20.0 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: Insulin lispro (ultra rapid formulation) Product Code: LY900014 Pharmaceutical Form: Solution for injection INN or Proposed INN: INSULIN L

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or female participants aged 6-64 with Type 1 Diabetes Mellitus (T1DM) for at least 1 year Glycated hemoglobin (HbA1c) less than (=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 12 months prior to screening 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the PK of insulin lispro following a single SC bolus dose administered through injection or CSII of LY900014 compared to Humalog in children, adolescents, and adults with T1DM; Secondary Objective: Evaluate the difference in GD response to LY900014 and Humalog administered through SC bolus injection or CSII, as assessed using the liquid MMTT in children, adolescents, and adults with T1DM Evaluate the tolerability of LY900014 following SC injection or CSII in children, adolescents, and adults with T1DM ;Primary end point(s): Early 50% tmax and AUC(0-30min);Timepoint(s) of evaluation of this end point: Predose through 420 minutes postdose	—

Measure

Time frame

Main Objective: Evaluate the PK of insulin lispro following a single SC bolus dose administered through injection or CSII of LY900014 compared to Humalog in children, adolescents, and adults with T1DM; Secondary Objective: Evaluate the difference in GD response to LY900014 and Humalog administered through SC bolus injection or CSII, as assessed using the liquid MMTT in children, adolescents, and adults with T1DM Evaluate the tolerability of LY900014 following SC injection or CSII in children, adolescents, and adults with T1DM ;Primary end point(s): Early 50% tmax and AUC(0-30min);Timepoint(s) of evaluation of this end point: Predose through 420 minutes postdose

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 1) 30 minutes predose through 5 hours post dose 2) Throughout study ; Secondary end point(s): 1) area under the baseline subtracted glucose concentration versus time curve from time 0 to 2 hours and 0 to 5 hours 2) To evaluate the tolerability of LY900014 following SC injection or CSII in children, adolescents, and adults with T1DM	—

Countries

Canada, Germany

Contacts

Public ContactClinical Trial Registry Office

Eli Lilly

EU_Lilly_Clinical_Trials@lilly.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026