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

Lilly

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: LY900014; Drug: Insulin Lispro (Humalog)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03056456

I8B-MC-ITSC (Other Identifier)

2016-004093-18 (EudraCT Number)

16727

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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• Have previously participated or withdrawn from this study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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups

LY900014

Experimental group

Description:

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.

Treatment:

Drug: LY900014

Insulin Lispro (Humalog)

Active Comparator group

Description:

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.

Treatment:

Drug: Insulin Lispro (Humalog)