Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03952130
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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).

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 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 Insulin Lispro in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 1 Diabetes
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: LY900014
LY900014 given subcutaneously (SC) with either insulin glargine given SC or insulin degludec given SC.
Drug: LY900014
Administered SC
Other Name: Ultra-Rapid Lispro

Drug: Insulin Glargine
Administered SC

Drug: Insulin Degludec
Administered SC

Active Comparator: Insulin Lispro
Insulin lispro (Humalog) given SC with either insulin glargine given SC or insulin degludec given SC.
Drug: Insulin Lispro
Administered SC
Other Names:
  • LY275585
  • Humalog

Drug: Insulin Glargine
Administered SC

Drug: Insulin Degludec
Administered SC




Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 26 ]
    Change from Baseline in HbA1c


Secondary Outcome Measures :
  1. 1-hour Postprandial Glucose (PPG) Excursion during Mixed-Meal Tolerance Test (MMTT) [ Time Frame: Week 26 ]
    1-hour PPG excursion during MMTT

  2. 2-hour PPG Excursion during MMTT [ Time Frame: Week 26 ]
    2-hour PPG excursion during MMTT

  3. Rate of Severe Hypoglycemia [ Time Frame: Baseline through Week 26 ]
    Rate of Severe Hypoglycemia

  4. Rate of Documented Symptomatic Postmeal Hypoglycemia [ Time Frame: Baseline through Week 26 ]
    Rate of Documented Symptomatic Postmeal Hypoglycemia

  5. Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) [ Time Frame: Baseline, Week 26 ]
    Change From Baseline in 1,5-AG

  6. 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

  7. Change from Baseline in Insulin Dose [ Time Frame: Baseline, Week 26 ]
    Change from Baseline in Insulin Dose

  8. Proportion of Participants with HbA1c <7% and ≤6.5% [ Time Frame: Week 26 ]
    Proportion of Participants with HbA1c <7% and ≤6.5%



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03952130


Contacts
Layout table for location 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 30 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Layout table for investigator information
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

Additional Information:
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03952130     History of Changes
Other Study ID Numbers: 16829
I8B-FH-ITSD ( Other Identifier: Eli Lilly and Company )
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 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

Layout table for additional information
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

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