A Study of LY900014 in Participants With Type 1 Diabetes on Insulin Injection Therapy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-07-31

Brief Summary

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The study will be conducted in participants with type1 diabetes on insulin injection therapy to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will be conducted in two parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in both parts.

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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 - Test (Part A)

Individualized doses of LY900014 administered by injection under the skin once in each of 3 periods

Group Type EXPERIMENTAL

LY900014

Intervention Type DRUG

Administered subcutaneously (SC)

Insulin Lispro - Reference (Part A)

Individualized doses of insulin lispro reference formulation administered by injection under the skin once in each of 3 periods

Group Type ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type DRUG

Administered SC

LY900014 - Test (Part B)

Individualized doses of LY900014 administered by injection under the skin immediately before each meal for 14 days

Group Type EXPERIMENTAL

LY900014

Intervention Type DRUG

Administered subcutaneously (SC)

Insulin Lispro - Reference (Part B)

Individualized doses of insulin lispro reference formulation administered by injection under the skin immediately before each meal for 14 days

Group Type ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type DRUG

Administered SC

Interventions

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LY900014

Administered subcutaneously (SC)

Intervention Type DRUG

Insulin Lispro

Administered SC

Intervention Type DRUG

Other Intervention Names

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Ultra-Rapid Lispro LY275585

Eligibility Criteria

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Inclusion Criteria

* Are male or female participants with Type 1 Diabetes Mellitus (T1DM) on a stable multiple daily injection regimen with a short-acting as well as a long-acting insulin
* Have a body mass index (BMI) ranging from 18.5 to 33.0 kilogram per square meter (kg/m²), inclusive, at screening
* Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results acceptable for the study
* Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party)
* 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 enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research judged to be incompatible with this study
* Have previously completed or withdrawn from this study
* Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
* Had blood loss of more than 500 milliliters (mL) within the last month
* Are treated with a continuous subcutaneous insulin infusion (insulin pump)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No