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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03830281
Recruitment Status : Active, not recruiting
First Posted : February 5, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE February 4, 2019
First Posted Date  ICMJE February 5, 2019
Last Update Posted Date November 6, 2019
Actual Study Start Date  ICMJE February 14, 2019
Estimated Primary Completion Date January 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 16 ]
Change from baseline in HbA1c
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03830281 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2019)
  • 1-hour Postprandial Glucose (PPG) During Mixed-Meal Tolerance Test (MMTT) [ Time Frame: Week 16 ]
    1-hour PPG during MMTT
  • 2-hour PPG During MMTT [ Time Frame: Week 16 ]
    2-hour PPG during MMTT
  • Percentage of Time with Sensor Glucose Values between 70 and 180 milligrams per deciliter (mg/dL) [ Time Frame: Week 16 ]
    Percentage of time with sensor glucose values between 70 and 180 mg/dL
  • Rate of Severe Hypoglycemia [ Time Frame: Baseline through Week 16 ]
    Rate of severe hypoglycemia
  • Rate of Documented Symptomatic Hypoglycemia [ Time Frame: Baseline through Week 16 ]
    Rate of documented symptomatic hypoglycemia
  • Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) [ Time Frame: Baseline, Week 16 ]
    Change from baseline in 1,5-AG
  • 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
  • Change from Baseline in Bolus/Total Insulin Dose Ratio [ Time Frame: Baseline, Week 16 ]
    Change from baseline in bolus/total insulin dose ratio
  • Percentage of Participants with HbA1c <7% and ≤6.5% [ Time Frame: Week 16 ]
    Percentage of participants with HbA1c <7% and ≤6.5%
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
  • 1-hour Postprandial Glucose (PPG) Excursion during Mixed-Meal Tolerance Test (MMTT) [ Time Frame: Week 16 ]
    1-hour PPG excursion during MMTT
  • 2-hour PPG Excursion during MMTT [ Time Frame: Week 16 ]
    2-hour PPG excursion during MMTT
  • Rate of Severe Hypoglycemia [ Time Frame: Baseline through Week 16 ]
    Rate of severe hypoglycemia
  • Rate of Documented Symptomatic Hypoglycemia [ Time Frame: Baseline through Week 16 ]
    Rate of documented symptomatic hypoglycemia
  • Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) [ Time Frame: Baseline, Week 16 ]
    Change from baseline in 1,5-AG
  • 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
  • Change from Baseline in Bolus/Total Insulin Dose Ratio [ Time Frame: Baseline, Week 16 ]
    Change from baseline in bolus/total insulin dose ratio
  • Percentage of Participants with HbA1c <7% and ≤6.5% [ Time Frame: Week 16 ]
    Percentage of participants with HbA1c <7% and ≤6.5%
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy
Official Title  ICMJE A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog in Adults With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE
  • Drug: LY900014
    Administered SC
    Other Name: Ultra-Rapid Lispro
  • Drug: Insulin Lispro
    Administered SC
    Other Names:
    • Humalog
    • LY275585
Study Arms  ICMJE
  • Experimental: LY900014
    LY900014 administered via continuous subcutaneous (SC) insulin infusion (CSII).
    Intervention: Drug: LY900014
  • Active Comparator: Insulin Lispro
    Insulin lispro (Humalog) administered via CSII.
    Intervention: Drug: Insulin Lispro
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 4, 2019)
526
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 3, 2020
Estimated Primary Completion Date January 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 (US), Paradigm Revel (US), or MiniMed 630G (US and Canada), MiniMed 640G or Paradigm Veo (select countries outside the US), 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Canada,   France,   Germany,   Hungary,   Israel,   Italy,   Puerto Rico,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03830281
Other Study ID Numbers  ICMJE 16315
I8B-MC-ITRO ( Other Identifier: Eli Lilly and Company )
2015-005358-36 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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://vivli.org/
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date November 1, 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP