A Study of LY900014 in Participants With Type 1 Diabetes Mellitus

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-26

Study Completion Date

2019-11-14

Brief Summary

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The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in participants with type 1 diabetes mellitus.

There are 2 parts to this study. Part A is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by subcutaneous injection. Part B of the study is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by continuous subcutaneous insulin infusion (CSII) pump.

Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 40 days in each part.

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Detailed Description

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Conditions

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Type 1 Diabetes Mellitus

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-Part A

Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014.

Group Type EXPERIMENTAL

LY900014

Intervention Type DRUG

Administered via SC injection

Humalog (Insulin Lispro)-Part A

Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL of Humalog.

Group Type ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type DRUG

Administered via SC injection

LY900014-Part B

Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the continuous subcutaneous insulin infusion (CSII) pump.

Group Type EXPERIMENTAL

LY900014

Intervention Type DRUG

Administered via SC injection

Humalog (Insulin Lispro)-Part B

Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.

Group Type ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type DRUG

Administered via SC injection

Interventions

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LY900014

Administered via SC injection

Intervention Type DRUG

Insulin Lispro

Administered via SC injection

Intervention Type DRUG

Other Intervention Names

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Ultra-Rapid Lispro Humalog LY275585

Eligibility Criteria

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Inclusion Criteria

* Are male or female participants aged 6-64 with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
* Have a glycated hemoglobin (HbA1c) less than (\<)10.0 percent (%)

Exclusion Criteria

* Receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 12 months prior to screening
* More than one episode of severe hypoglycaemia in the last 6 months
* Presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, proliferative retinopathy, uncontrolled celiac disease, uncontrolled hyperthyroidism or hypothyroidism, or adrenal insufficiency
* Have obvious clinical signs or symptoms of liver disease
* Have a history of renal impairment

Minimum Eligible Age

6 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No