Clinical trial NCT03433677: A Study of LY900014 and Insulin Lispro With an External Continuous Subcutaneous Insulin Infusion System in Adult Participants With Type 1 Diabetes
Official title: A Prospective, Randomized, Double-Blind, Crossover Comparison Evaluating Compatibility and Safety of LY900014 and Insulin Lispro With an External Continuous Subcutaneous Insulin Infusion System in Adult Patients With Type 1 Diabetes (PRONTO-Pump)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Type 1
Keywords: insulin pump
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-02-14
Enrollment: 49
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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Infusion Set Failures
timeFrame: 6 Weeks
Secondary outcomes:
measure: Percentage of Participants With at Least 1 Event of Infusion Set Failure
timeFrame: 6 Weeks
measure: Rate of Premature Infusion Set Changes
timeFrame: 6 Weeks
measure: Time Interval Until Infusion Set Change
timeFrame: 6 Weeks
measure: Ratio of Bolus/Total Insulin Dose
timeFrame: 6 Weeks
measure: Interstitial Glucose Reduction Rate From Hyperglycemia Following a Non-Meal-Related Correction Bolus Delivered Via the Pump
timeFrame: 6 Weeks
measure: Number of Participants With Severe Hypoglycemic Events
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Valley Research
state: California
city: Aurora
country: United States
facility: Barbara Davis Center for Childhood Diabetes
state: Colorado
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Sevilla
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
city: Seville
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: 1-877-CTLILLY (1-877-285-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: