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

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ClinicalTrials.gov Identifier: NCT03433677
Recruitment Status : Completed
First Posted : February 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Diabetes Type 1 Drug: LY900014 Drug: Insulin lispro Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : February 21, 2018
Actual Primary Completion Date : September 4, 2018
Actual Study Completion Date : September 4, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: LY900014
LY900014 administered by continuous subcutaneous insulin infusion (CSII)
Drug: LY900014
Administered by CSII

Experimental: Insulin Lispro
Insulin lispro administered by CSII
Drug: Insulin lispro
Administered by CSII
Other Name: Humalog




Primary Outcome Measures :
  1. Rate of Infusion Set Failures [ Time Frame: 6 Weeks ]
    Infusion set failures are defined as premature infusion set changes, due to a pump occlusion alarm OR due to unexplained hyperglycemia with blood glucose (SMBG) >250 milligrams per deciliter (mg/dL) (13.9 millimoles per liter [mmol/L]) that does not decrease within 1 hour following a correction bolus delivered via the pump


Secondary Outcome Measures :
  1. Percent of Participants with at Least 1 Event of Infusion Set Failure [ Time Frame: 6 Weeks ]
    Infusion set failures are defined as premature infusion set changes, due to a pump occlusion alarm OR due to unexplained hyperglycemia with blood glucose (SMBG) >250mg/dL (13.9 mmol/L) that does not decrease within 1 hour following a correction bolus delivered via the pump

  2. Rate of Premature Infusion Set Changes [ Time Frame: 6 Weeks ]
    Rate of premature infusion set changes

  3. Time Interval until Infusion Set Change [ Time Frame: 6 Weeks ]
    Time interval until infusion set change

  4. Bolus/total insulin dose ratio [ Time Frame: 6 Weeks ]
    Bolus/total insulin dose ratio

  5. Interstitial Glucose Reduction Rate from Hyperglycemia Following a Non-Meal-Related Correction Bolus Delivered Via the Pump [ Time Frame: 6 Weeks ]
    Interstitial glucose reduction rate from hyperglycemia following a non-meal-related correction bolus delivered via the pump

  6. Rate of Severe Hypoglycemic Events [ Time Frame: 6 Weeks ]
    Rate of severe hypoglycemic events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433677


Locations
United States, California
Valley Research
Fresno, California, United States, 93720
United States, Colorado
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
Spain
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.
Sevilla, Spain, 41009
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.
Seville, Spain, 41003
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 1-877-CTLILLY (1-877-285-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03433677     History of Changes
Other Study ID Numbers: 16908
I8B-MC-ITSI ( Other Identifier: Eli Lilly and Company )
2017-002374-39 ( EudraCT Number )
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eli Lilly and Company:
insulin pump

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs