Back to results

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

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

LY900027

Insulin Lispro

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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

Exclusion Criteria:

Sites / Locations

Profil Institut für Stoffwechselforschung

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LY900027

Insulin Lispro

Arm Description

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

Insulin lispro administered to participants with T1DM using CSII in one of two dosing periods.

Outcomes

Primary Outcome Measures

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

PK: Maximum Observed Insulin Lispro Concentration (Cmax)

PK: C PK: Cmax

Secondary Outcome Measures

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

PD: Total Daily Insulin Dose

Duration Until Catheter Failure

Full Information

NCT ID

NCT04161976

First Posted

November 12, 2019

Last Updated

August 4, 2020

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT04161976

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 1, 2020

Overall Recruitment Status

Completed

Study Start Date

December 27, 2019 (Actual)

Primary Completion Date

July 14, 2020 (Actual)

Study Completion Date

July 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LY900027

Arm Type

Experimental

Arm Description

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

Arm Title

Insulin Lispro

Arm Type

Active Comparator

Arm Description

Insulin lispro administered to participants with T1DM using CSII in one of two dosing periods.

Intervention Type

Drug

Intervention Name(s)

LY900027

Intervention Description

LY900027 administered to participants with T1DM using CSII.

Intervention Type

Drug

Intervention Name(s)

Insulin Lispro

Other Intervention Name(s)

Humalog, LY275585

Intervention Description

Insulin lispro administered to participants with T1DM using CSII.

Primary Outcome Measure Information:

Title

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)

Description

PK: AUC after Bolus Administration Prior to a MMTT

Time Frame

Day 1 through Day 10 in each dosing period

Title

PK: Maximum Observed Insulin Lispro Concentration (Cmax)

Description

PK: C PK: Cmax

Time Frame

Day 1 through Day 10 in each dosing period

Secondary Outcome Measure Information:

Title

Pharmacodynamics (PD): Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion

Description

PD: Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion

Time Frame

Day 1 through Day 10 in each dosing period

Title

PD: Total Daily Insulin Dose

Description

PD: Total Daily Insulin Dose

Time Frame

Day 1 through Day 10 in each dosing period

Title

Duration Until Catheter Failure

Description

Duration Until Catheter Failure

Time Frame

Day -1 through Day 10 in each dosing period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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:

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Profil Institut für Stoffwechselforschung

City

Neuss

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

41460

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs