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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-27

Study Completion Date

2020-07-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY900027

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

Group Type EXPERIMENTAL

LY900027

Intervention Type DRUG

LY900027 administered to participants with T1DM using CSII.

Insulin Lispro

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

Group Type ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type DRUG

Insulin lispro administered to participants with T1DM using CSII.

Interventions

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LY900027

LY900027 administered to participants with T1DM using CSII.

Intervention Type DRUG

Insulin Lispro

Insulin lispro administered to participants with T1DM using CSII.

Intervention Type DRUG

Other Intervention Names

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Humalog LY275585

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No