A Study of LY900027 Given by Insulin Pump to Participants With Type 1 Diabetes Mellitus

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: LY900027; Drug: Insulin Lispro

• Registration Number: NCT04161976
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-11-12
• Study First Posted: 2019-11-13
• Study Start: 2019-12-27
• Primary Completion: 2020-07-14
• Study Completion: 2020-07-14
• Status Verified: 2020-08-01
• Last Update Submitted: 2020-08-04
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY900027	LY900027	LY900027 administered to participants with type 1 diabetes mellitus (T1DM) using continuous subcutaneous insulin infusion (CSII) in one of two dosing periods.
Insulin Lispro	Insulin Lispro	Insulin lispro administered to participants with T1DM using CSII in one of two dosing periods.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Duration Until Catheter Failure	Day -1 through Day 10 in each dosing period	Duration Until Catheter Failure
PD: Total Daily Insulin Dose	Day 1 through Day 10 in each dosing period	PD: Total Daily Insulin Dose

Trial Locations

Locations (1)

Profil Institut für Stoffwechselforschung; 🇩🇪 Neuss, Nordrhein-Westfalen, Germany