A Study of LY900014 and Insulin Lispro With an External Continuous Subcutaneous Insulin Infusion System in Adult Participants With Type 1 Diabetes

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-21

Study Completion Date

2018-09-04

Brief Summary

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The purpose of this study is to evaluate the compatibility and safety of LY900014 and insulin lispro with an external continuous subcutaneous insulin infusion system in adult participants with type 1 diabetes.

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Detailed Description

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Conditions

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Diabetes Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY900014

100 units per milliliter (U/mL) LY900014 administered by individualized, continuous, subcutaneous insulin infusion (CSII)

Group Type EXPERIMENTAL

LY900014

Intervention Type DRUG

Administered by CSII

Insulin Lispro

100 U/mL insulin lispro (Humalog®) administered by individualized CSII

Group Type EXPERIMENTAL

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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Ultra-Rapid Lispro Humalog

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with type 1 diabetes and have been using insulin continuously for at least 12 months.
* Using an insulin pump with 'rapid-acting insulin' for at least 6 months and using the same rapid-acting insulin for at least the past 30 days.
* Have experience using Continuous Glucose Monitoring (CGM) or Flash Glucose Monitoring (FGM) for at least 60 days during the past 12 months.
* Have hemoglobin A1c values ≤8.5%, as determined by the central laboratory at screening.
* Have a body mass index (BMI) of ≤35 kilograms per meter squared at screening.
* Have been using the MiniMed 530G or 630G (US) or the MiniMed 640G (EU) insulin pump for at least the past 30 days.

Exclusion Criteria

* Have had more than 1 emergency treatment for very low blood glucose in the last 6 months.
* Have had more than 1 emergency treatment for poor glucose control (hyperglycemia or diabetic ketoacidosis) in the last 6 months.
* Have significant insulin resistance defined as having received a total daily dose of insulin \>1.2 units per kilogram (U/kg) at screening, as determined by the average total daily insulin dose over the 3 days prior to screening divided by weight in kilograms based on investigator review of the participant's pump history.
* Have significant lipohypertrophy, lipoatrophy, or scars within the subcutaneous tissue in areas of infusion or have a history of abscess at an infusion site within the last 90 days prior to screening.
* Are receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than rapid-acting analog insulin via CSII in the 90 days prior to screening. Occasional pen or syringe injection of insulin is allowed, for example, due to pump malfunction or unexplained hyperglycemia not responsive to pump correction bolus.
* Taking certain diabetes medications that are not allowed for study participation.
* Have major problems with heart, kidneys, liver, or have a blood disorder.
* Have had or are now being treated for certain types of cancer that prevents study participation.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No