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A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes

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: NCT03952130
Recruitment Status : Active, not recruiting
First Posted : May 16, 2019
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE May 14, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date June 18, 2021
Actual Study Start Date  ICMJE May 29, 2019
Estimated Primary Completion Date December 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 26 ]
Change from Baseline in HbA1c
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • 1-hour Postprandial Glucose (PPG) Excursion during Mixed-Meal Tolerance Test (MMTT) [ Time Frame: Week 26 ]
    1-hour PPG excursion during MMTT
  • 2-hour PPG Excursion during MMTT [ Time Frame: Week 26 ]
    2-hour PPG excursion during MMTT
  • Rate of Severe Hypoglycemia [ Time Frame: Baseline through Week 26 ]
    Rate of Severe Hypoglycemia
  • Rate of Documented Symptomatic Postmeal Hypoglycemia [ Time Frame: Baseline through Week 26 ]
    Rate of Documented Symptomatic Postmeal Hypoglycemia
  • Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) [ Time Frame: Baseline, Week 26 ]
    Change From Baseline in 1,5-AG
  • Change from Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values [ Time Frame: Baseline, Week 26 ]
    Change from Baseline in 10-Point SMBG Values
  • Change from Baseline in Insulin Dose [ Time Frame: Baseline, Week 26 ]
    Change from Baseline in Insulin Dose
  • Proportion of Participants with HbA1c <7% and ≤6.5% [ Time Frame: Week 26 ]
    Proportion of Participants with HbA1c <7% and ≤6.5%
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes
Official Title  ICMJE A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 1 Diabetes
Brief Summary The purpose of this study is to see if LY900014 compared to insulin lispro (Humalog), both in combination with insulin glargine or insulin degludec, is safe and effective in participants 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:
    • LY275585
    • Humalog
  • Drug: Insulin Glargine
    Administered SC
  • Drug: Insulin Degludec
    Administered SC
Study Arms  ICMJE
  • Experimental: LY900014
    LY900014 given subcutaneously (SC) with either insulin glargine given SC or insulin degludec given SC.
    Interventions:
    • Drug: LY900014
    • Drug: Insulin Glargine
    • Drug: Insulin Degludec
  • Active Comparator: Insulin Lispro
    Insulin lispro (Humalog) given SC with either insulin glargine given SC or insulin degludec given SC.
    Interventions:
    • Drug: Insulin Lispro
    • Drug: Insulin Glargine
    • Drug: Insulin Degludec
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: May 14, 2019)
350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 28, 2021
Estimated Primary Completion Date December 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants must have T1D for at least 1 year prior to screening and continuously using insulin for at least 1 year.
  • Participants must have HbA1c of ≥7.0 and ≤10.0%.
  • Participants must have been treated for at least 90 days prior to screening with either multiple daily injection(s) (MDI) or premixed analog/human insulin regimens at least twice daily.
  • Participants must have body mass index (BMI) of ≤35.0 kilograms per square meter (kg/m2).

Exclusion Criteria:

  • Participants must not have used other anti-hyperglycemic medications or therapies (inhaled, oral or injectable) except for metformin within 90-days of screening.
  • Participants must not have had more than 1 severe hypoglycemic episode within 6 months of screening.
  • Participants must not have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months of 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 Argentina,   China,   Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03952130
Other Study ID Numbers  ICMJE 16829
I8B-FH-ITSD ( Other Identifier: Eli Lilly and Company )
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
Product Manufactured in and Exported from the U.S.: Yes
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: https://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 June 15, 2021

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