A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-25

Study Completion Date

2020-08-10

Brief Summary

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The main purpose of this study is to compare LY900014 to insulin lispro (Humalog) in participants with type 1 diabetes who are using an insulin pump and have high blood sugar after eating. For each participant, the study will last about two to nine weeks.

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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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100 U/mL LY900014

100 units per milliliter (U/mL) LY900014 administered by continuous subcutaneous insulin infusion (CSII) in one of two study periods.

Group Type EXPERIMENTAL

LY900014

Intervention Type DRUG

Administered by CSII

100 U/mL Insulin Lispro (Humalog)

100 U/mL Insulin Lispro (Humalog) administered by CSII in one of two study periods.

Group Type ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type DRUG

Administered by CSII

Interventions

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LY900014

Administered by CSII

Intervention Type DRUG

Insulin Lispro

Administered by CSII

Intervention Type DRUG

Other Intervention Names

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Humalog LY275585

Eligibility Criteria

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Inclusion Criteria

* Male or female participants with type 1 diabetes
* Body mass index (BMI) between 18.5 and 30.0 kilograms per square meter, inclusive
* Hemoglobin A1c (HbA1c) less than or equal to 8.5 percent (%)
* Using CSII and stable insulin regimen for at least 3 months prior to inclusion into the trial

Exclusion Criteria

* Known or suspected hypersensitivity to investigational medical product(s) or related products
* Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomization in this trial
* Known slowing of gastric emptying and or gastrointestinal surgery that, in the opinion of the investigator, might change gastrointestinal motility and food absorption
* Proliferative retinopathy or maculopathy as judged by the Investigator based on a recent (less than 1.5 years) ophthalmologic examination
* Widespread subcutaneous lipodystrophy in the abdomen
* Current use of any glucose-lowering agents other than insulin within 3 months prior to screening
* Chronic or recent use of corticosteroids

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No