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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04161976
• Other study ID #: 17489
• Secondary ID: J2H-MC-IUAA2019-
• Status: Completed
• Phase: Phase 1
• Start date: December 27, 2019
• Est. completion date: July 14, 2020

Study information

• Verified date: August 1, 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 14, 2020
• Est. primary completion date: July 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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:

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• LY900027
LY900027 administered to participants with T1DM using CSII.
• Insulin Lispro
Insulin lispro administered to participants with T1DM using CSII.

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung	Neuss	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	PK: Maximum Observed Insulin Lispro Concentration (Cmax)	PK: C PK: Cmax	Day 1 through Day 10 in each dosing period
Secondary	Pharmacodynamics (PD): Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion	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
Secondary	PD: Total Daily Insulin Dose	PD: Total Daily Insulin Dose	Day 1 through Day 10 in each dosing period
Secondary	Duration Until Catheter Failure	Duration Until Catheter Failure	Day -1 through Day 10 in each dosing period