A Study of LY900014 in a Medtronic Pump

Lilly

Status and phase: Completed; Phase 2

Conditions: Type1 Diabetes Mellitus

Treatments: Drug: LY900014; Drug: Insulin Lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT03760640

I8B-MC-ITSM (Other Identifier)

16917

Details and patient eligibility

About

The purpose of this study is to compare the study drug LY900014 to insulin lispro (Humalog) when both are delivered by the Medtronic MiniMed 670G System in adults with type 1 diabetes (T1D). The study will consist of two treatment periods of 4 weeks.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have been diagnosed with type 1 diabetes and have been using insulin continuously for at least 12 months
• Participants must be using an insulin pump with "rapid-acting insulin" for at least 6 months and the same "rapid acting insulin" for at least the past 30 days
• Participants must have hemoglobin A1c (HbA1c) values ≥6.0% and ≤8.0%
• Participants must have been using the MiniMed 670G insulin pump for at least the past 90 days
• Participants must use their Guardian (3) sensor at least an average of 75% of the time and remain in Auto Mode an average of 70% of the time

Exclusion criteria

• Participants must not have had more than 1 emergency treatment for very low blood glucose or any hospitalizations for poor glucose control (very high blood sugar or diabetic ketoacidosis) in the last 6 months
• Participants must not have significant abnormal accumulation of fat, loss of fat tissue, or scars just under the skin in areas of infusion or have a history of an infection at an infusion site within 90 days prior to screening
• Participants must not have a total daily insulin dose >100 units
• Participants must not be receiving any oral or injectable medication intended for the treatment of diabetes other than rapid-acting analog insulin via CSII in the 30 days prior to screening
• Participants must not have major problems with their heart, kidneys, liver, or have a blood disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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42 participants in 2 patient groups

LY900014

Experimental group

Description:

Participants received 100 units per milliliter (U/mL) of LY900014 administered via continuous subcutaneous insulin infusion (CSII) by the Medtronic MiniMed 670G insulin pump.

Treatment:

Drug: LY900014

Insulin Lispro (Humalog)

Active Comparator group

Description:

Participants received 100 U/mL of Insulin lispro (Humalog) administered via CSII by the Medtronic MiniMed 670G insulin pump.

Treatment:

Drug: Insulin Lispro