Clinical trial NCT03760640: A Study of LY900014 in a Medtronic Pump
Official title: Evaluation of LY900014 in a Medtronic Pump
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type1 Diabetes Mellitus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-11-30
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) (24-Hour)
timeFrame: Week 2 through Week 4
Secondary outcomes:
measure: Mean Sensor Glucose Value (24-Hour)
timeFrame: Week 2 through Week 4
measure: Percentage of Time Spent in Auto Mode
timeFrame: Week 2 through Week 4
measure: Percentage of Time With Sensor Glucose Values <54 mg/dL (24-Hour)
timeFrame: Week 2 through Week 4
measure: Rate of Severe Hypoglycemic Events
timeFrame: Week 2 through Week 4
measure: Total Daily Insulin Dose
timeFrame: Week 2 through Week 4
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Saint Louis Park
country: United States
facility: International Diabetes Center
state: Minnesota
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Bode B, Carlson A, Liu R, Hardy T, Bergenstal R, Boyd J, Morrett S, Ignaut D. Ultrarapid Lispro Demonstrates Similar Time in Target Range to Lispro with a Hybrid Closed-Loop System. Diabetes Technol Ther. 2021 Dec;23(12):828-836. doi: 10.1089/dia.2021.0184. Epub 2021 Oct 26.