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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04161976

Enrollment

Registered

2019-11-13

Start date

2019-12-27

Completion date

2020-07-14

Last updated

2020-08-05

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

Conditions

Diabetes Mellitus, Type 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.

Interventions

DRUGLY900027

LY900027 administered to participants with T1DM using CSII.

DRUGInsulin Lispro

Insulin lispro administered to participants with T1DM using CSII.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Inclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
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)	Day 1 through Day 10 in each dosing period	PK: AUC after Bolus Administration Prior to a MMTT
PK: Maximum Observed Insulin Lispro Concentration (Cmax)	Day 1 through Day 10 in each dosing period	PK: C PK: Cmax

Secondary

Measure	Time frame	Description
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: Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion
PD: Total Daily Insulin Dose	Day 1 through Day 10 in each dosing period	PD: Total Daily Insulin Dose
Duration Until Catheter Failure	Day -1 through Day 10 in each dosing period	Duration Until Catheter Failure

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026