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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT03952130
Collaborator
(none)
354
Enrollment
30
Locations
2
Arms
31.4
Actual Duration (Months)
11.8
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: LY900014
  • Drug: Insulin Lispro
  • Drug: Insulin Glargine
  • Drug: Insulin Degludec
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
354 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 29, 2019
Actual Primary Completion Date :
Jan 10, 2022
Actual Study Completion Date :
Jan 10, 2022

Arms and Interventions

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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in Hemoglobin A1c (HbA1c) [Baseline, Week 26]

      Change from Baseline in HbA1c

    Secondary Outcome Measures

    1. 1-hour Postprandial Glucose (PPG) Excursion during Mixed-Meal Tolerance Test (MMTT) [Week 26]

      1-hour PPG excursion during MMTT

    2. 2-hour PPG Excursion during MMTT [Week 26]

      2-hour PPG excursion during MMTT

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

      Rate of Severe Hypoglycemia

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

      Rate of Documented Symptomatic Postmeal Hypoglycemia

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

      Change From Baseline in 1,5-AG

    6. Change from Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values [Baseline, Week 26]

      Change from Baseline in 10-Point SMBG Values

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

      Change from Baseline in Insulin Dose

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

      Proportion of Participants with HbA1c <7% and ≤6.5%

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centro de Investigaciones Metabólicas (CINME) Caba Buenos Aires Argentina C1056ABJ
    2 Centro Médico Viamonte Caba Buenos Aires Argentina C1120AAC
    3 Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC Cordoba Argentina X5008HHW
    4 The Second People's Hospital of Hefei Hefei Anhui China 230011
    5 Shantou University Medical College No.2 Affiliated Hospital Shantou Guang Dong Province China 515041
    6 Dongguan people's hospital Dongguan Guangdong China 523059
    7 Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong China 510120
    8 Shenzhen Second People's Hospital Shenzhen Guangdong China 518039
    9 The Fourth Affiliated Hospital of Harbin Medical University Harbin Heilongjiang China 150001
    10 The First Affiliated Hospital of Henan University of Science &Technology Luoyang Henan China 471003
    11 The First People's Hospital of Changde City Changde Hunan China 415003
    12 The Second Xiangya Hospital of Central South University Changsha Hunan China 410011
    13 Changzhou No.2 People's Hospital Changzhou Jiangsu China 213003
    14 Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School Nanjing Jiangsu China 210000
    15 The First Hospital of Nanjing Nanjing Jiangsu China 210006
    16 Sir Run Run Hospital of Nanjing Medical University Nanjing Jiangsu China 211166
    17 The Second Affiliated Hospital of Soochow University Suzhou Jiangsu China 215004
    18 Affiliated Hospital of Jiangsu University Zhenjiang Jiangsu China 212000
    19 No.2 Hospital Affiliated to Jilin University Changchun City Jilin China 130041
    20 The First Hospital of Jilin University Changchun Jilin China 130021
    21 Shengjing Hospital of China Medical University Shenyang Liaoning China 110004
    22 Jiangsu Province Hospital Nanjing Nanjing China 210029
    23 Shanghai Tenth People's Hospital Shanghai Shanghai China 200072
    24 West China Hospital Sichuan University Chengdu Sichuan China 610041
    25 Beijing Peking Union Medical College Hospital Beijing China 100730
    26 Shanghai Putuo District Center Hospital Shanghai China 200062
    27 Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine Shanghai China 200092
    28 Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente Guadalajara Jalisco Mexico 44150
    29 Unidad de patologia Clinica Guadalajara Jalisco Mexico 44650
    30 Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey N.l. Mexico 64460

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03952130
    Other Study ID Numbers:
    • 16829
    • I8B-FH-ITSD
    First Posted:
    May 16, 2019
    Last Update Posted:
    Feb 21, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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:
    Diabetes Mellitus
    Diabetes Mellitus, Type 1
    Insulin
    Insulin, Globin Zinc
    Insulin Glargine
    Insulin Lispro

    Study Results

    No Results Posted as of Feb 21, 2022