A Study of LY900014 Administered in Participants With Type 1 Diabetes Using an Insulin Pump

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-23

Study Completion Date

2017-06-19

Brief Summary

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This study will be conducted in participants with type 1 diabetes mellitus to investigate how the human body processes LY900014, a new blood sugar lowering insulin, and its effect on blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability will be documented. The study will last about 4 to 11 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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LY900014

LY900014 (Treatment B) delivered via an insulin pump as a continuous infusion under the skin, with various intermittent bolus doses immediately before meals over 3-days per period.

Group Type EXPERIMENTAL

LY900014

Intervention Type DRUG

Administered subcutaneously (SC)

Insulin Lispro (Humalog)

Insulin lispro (Treatment A) delivered via an insulin pump as a continuous infusion under the skin, with various intermittent bolus doses immediately before meals over 3-days per period.

Group Type ACTIVE_COMPARATOR

Insulin Lispro (Humalog)

Intervention Type DRUG

Administered SC

Interventions

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LY900014

Administered subcutaneously (SC)

Intervention Type DRUG

Insulin Lispro (Humalog)

Administered SC

Intervention Type DRUG

Other Intervention Names

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Ultra-Rapid Lispro LY275585 Humalog

Eligibility Criteria

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Inclusion Criteria

* Male or female participants with Type 1 Diabetes Mellitus (T1DM) who are receiving insulin therapy via an approved insulin pump
* Have a screening body mass index (BMI) of greater than 18.5 to 33.0 kilograms per meter squared (kg/m²), inclusive
* Have medical and laboratory test results that are acceptable for the study
* Have had no episodes of severe hypoglycemia (requiring assistance in treatment by a second party) in the past 6 months
* Have venous access sufficient to allow for blood sampling
* Have provided written consent and are willing to follow study procedures and commit to the study duration

Exclusion Criteria

* Are currently participating or recently participated in a clinical trial or any other type of medical research judged to be incompatible with this study
* Had blood loss of more than 500 milliliters (mL) within the last month
* Have known allergies to LY900014, insulin lispro, related compounds or any components in the study drug formulations
* Have previously participated or withdrawn from this study
* Have or used to have health problems or medical test results that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No