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A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy (PRONTO-Pump-2)

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ClinicalTrials.gov Identifier: NCT03830281
Recruitment Status : Not yet recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) when both are used in insulin pump therapy in adults with type 1 diabetes (T1D).

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 526 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog in Adults With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion
Estimated Study Start Date : February 14, 2019
Estimated Primary Completion Date : November 25, 2019
Estimated Study Completion Date : November 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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

Active Comparator: Insulin Lispro
Insulin lispro (Humalog) administered via CSII.
Drug: Insulin Lispro
Administered SC
Other Names:
  • Humalog
  • LY275585




Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 16 ]
    Change from baseline in HbA1c


Secondary Outcome Measures :
  1. 1-hour Postprandial Glucose (PPG) Excursion during Mixed-Meal Tolerance Test (MMTT) [ Time Frame: Week 16 ]
    1-hour PPG excursion during MMTT

  2. 2-hour PPG Excursion during MMTT [ Time Frame: Week 16 ]
    2-hour PPG excursion during MMTT

  3. Rate of Severe Hypoglycemia [ Time Frame: Baseline through Week 16 ]
    Rate of severe hypoglycemia

  4. Rate of Documented Symptomatic Hypoglycemia [ Time Frame: Baseline through Week 16 ]
    Rate of documented symptomatic hypoglycemia

  5. Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) [ Time Frame: Baseline, Week 16 ]
    Change from baseline in 1,5-AG

  6. Change from Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values [ Time Frame: Baseline, Week 16 ]
    Change from baseline in 10-point SMBG values

  7. Change from Baseline in Bolus/Total Insulin Dose Ratio [ Time Frame: Baseline, Week 16 ]
    Change from baseline in bolus/total insulin dose ratio

  8. Percentage of Participants with HbA1c <7% and ≤6.5% [ Time Frame: Week 16 ]
    Percentage of participants with HbA1c <7% and ≤6.5%

  9. Percentage of Time with Sensor Glucose Values between 71 and 180 milligrams per deciliter (mg/dL) [ Time Frame: Week 16 ]
    Percentage of time with sensor glucose values between 71 and 180 mg/dL

  10. Percentage of Participants with at Least 1 Pump Occlusion Alarm that Leads to an Unplanned Infusion Set Change [ Time Frame: Baseline through Week 16 ]
    Percentage of participants with at least 1 pump occlusion alarm that leads to an unplanned infusion set change

  11. Percentage of Participants with at Least 1 Event of Unexplained Hyperglycemia >300 mg/dL confirmed by SMBG that Leads to an Unplanned Infusion Set Change [ Time Frame: Baseline through Week 16 ]
    Percentage of participants with at least 1 event of unexplained hyperglycemia >300 milligrams per deciliter (mg/dL) confirmed by SMBG that leads to an unplanned infusion set change



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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:

  • Have been diagnosed with T1D and continuously using insulin for at least 1 year
  • Have been using CSII therapy for a minimum of 6 months
  • Currently treated with <100 Units of one of following rapid-acting analog insulin via CSII for at least the past 30 days: insulin lispro U-100, insulin aspart, fast-acting insulin aspart, insulin glulisine
  • Must be using a MiniMed 530G or 630G (US), 640G (EU) insulin pump for at least the past 90 days

Exclusion Criteria:

  • Have hypoglycemia unawareness
  • Have had more than 1 episode of severe hypoglycemia within 6 months prior to screening
  • Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening

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): NCT03830281


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

  Show 84 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03830281     History of Changes
Other Study ID Numbers: 16315
I8B-MC-ITRO ( Other Identifier: Eli Lilly and Company )
2015-005358-36 ( EudraCT Number )
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://www.clinicalstudydatarequest.com

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

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