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A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT03952143
Collaborator
(none)
628
Enrollment
41
Locations
2
Arms
19.8
Actual Duration (Months)
15.3
Patients Per Site
0.8
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 2 diabetes (T2D).

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 :
628 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, Both in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 2 Diabetes
Actual Study Start Date :
May 27, 2019
Actual Primary Completion Date :
Jan 20, 2021
Actual Study Completion Date :
Jan 20, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY900014

Participants received 100 units per milliliter (U/mL) LY900014 subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.

Drug: LY900014
Administered SC
Other Names:
  • Ultra-Rapid Lispro

    • Drug: Insulin Glargine
    Administered SC

    Drug: Insulin Degludec
    Administered SC
    Active Comparator: Insulin Lispro

    Participants received 100 U/mL insulin lispro (Humalog) given SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.

    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]

      HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Pooled Country + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares).

    Secondary Outcome Measures

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

      A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares).

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

      A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares).

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

      Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within that treatment group *36525.

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

      Documented symptomatic postmeal hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of ≤70 mg/dL [3.9 millimole per liter (mmol/L)]. The rate of documented symptomatic postmeal hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable

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

      1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares)

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

      SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares).

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

      LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares)

    8. Percentage of Participants With HbA1c <7% and ≤6.5% [Week 26]

      Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Only subjects with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.

    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 T2D based on the disease diagnostic criteria World Health Organization (WHO) classification.

    • Participants must have been treated for at least 90 days prior to screening with either basal insulin + at least 1 prandial injection of bolus insulin or premixed analog/human insulin regimens at least twice daily.

    • Participants must be treated no more than 3 oral anti-hyperglycemic medications (OAMs).

    • Participants must have a HbA1c ≥7.0% and ≤11.0%.

    • Participants must have body mass index (BMI) of ≤35.0 kilograms per meter squared (kg/m2).

    Exclusion Criteria:

    • Participants must not have been diagnosed, at any time, with type 1 diabetes (T1D) or latent autoimmune diabetes in adults.

    • Participants must not have had any episode of severe hypoglycemia within the 6 months prior to screening.

    • Participants must not have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening.

    • Participants must not have used thiazolidinediones, glucagon-like peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centro Médico Viamonte Buenos Aires Ar-c Argentina C1120AAC
    2 Centro de Investigaciones Metabólicas (CINME) Caba Buenos Aires Argentina C1056ABJ
    3 Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC Cordoba Argentina X5008HHW
    4 Beijing Pinggu District Hospital Beijing Cn-11 China 101200
    5 Tianjin Medical University General Hospital Tianjin Cn-12 China 300052
    6 Cangzhou People's Hospital Cangzhou Cn-13 China 061000
    7 The First Hospital of Qinhuangdao Qinhuangdao Shi Cn-13 China 066000
    8 Inner Mongolia People's Hospital Hohhot Cn-15 China 010017
    9 Dalian Municipal Central Hospital Affiliated of Dalian Medical University Dalian Cn-21 China 116033
    10 Shengjing Hospital of China Medical University Shenyang Cn-21 China 110004
    11 Shanghai Putuo District Center Hospital Shanghai Cn-31 China 200062
    12 Shanghai 6th people's hospital Shanghai Cn-31 China
    13 The Affiliated Jiangyin Hospital of Southeast University Medical College Jiangyin Cn-32 China 214400
    14 Zhongda Hospital Southeast University Nanjing Cn-32 China 210009
    15 Nanjing Medical University - Nanjing Jiangning Hospital Nanjing Cn-32 China 211100
    16 Affiliated Hospital of Jiangsu University Zhenjiang Cn-32 China 212000
    17 The Third Hospital of Nanchang Nanchang Cn-36 China 330009
    18 The Central Hospital of Wuhan Wuhan Cn-42 China
    19 The First People's Hospital of Yueyang Yueyang Cn-43 China 414000
    20 Chongqing General Hospital Chongqing Cn-50 China 400014
    21 Fujian Medical University Union Hospital Fuzhou Fujian China 350001
    22 Xingtai People's Hospital Xingtai Hebei China 054031
    23 The Fourth Affiliated Hospital of Harbin Medical University Harbin Heilongjiang China 150001
    24 The First Hospital of Qiqihar Qiqihar Heilongjiang China 161006
    25 The First Affiliated Hospital of Henan University of Science &Technology Luoyang Henan China 471003
    26 Wuhan Pu'ai Hospital Wuhan Hubei China 430000
    27 Yichang Central People's Hospital Yichang Hubei China 443003
    28 Chenzhou NO.1 People's Hospital Chenzhou Hunan China 424300
    29 Changzhou No.2 People's Hospital Changzhou Jiangsu China 213003
    30 The First Hospital of Nanjing Nanjing Jiangsu China 210012
    31 China-Japan Union Hospital, CJUH. Changchun Jilin China 130033
    32 Siping Central People's Hospital Siping Jilin China 136000
    33 Qinghai University Affiliated Hospital Xining Qinghai China 810001
    34 Jinan Central Hospital Jinan Shandong China 250013
    35 The First Affiliated Hospital of Xi'an Medical University XI 'an Shanxi China
    36 Beijing Peking Union Medical College Hospital Beijing China 100730
    37 Pingxiang People's Hospital Pingxiang China 337000
    38 Unidad de patologia Clinica Guadalajara Jalisco Mexico 44650
    39 Centro de Inv. Medica de Occidente, SC Zapopan Jalisco Mexico 45116
    40 Unidad Médica para la Salud Integral San Nicolás de los Garza Mx-nle Mexico 66465
    41 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)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03952143
    Other Study ID Numbers:
    • 16830
    • I8B-FH-ITSE
    First Posted:
    May 16, 2019
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Jan 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 2
    Insulin
    Insulin, Globin Zinc
    Insulin Glargine
    Insulin Lispro

    Study Results

    Participant Flow

    Recruitment Details The study included 8-week lead-in period followed by a 26-week treatment period.
    Pre-assignment Detail The purpose of the lead-in period (prior to randomization) was to titrate basal insulin, obtain preliminary diagnostic laboratory tests, and determine baseline hypoglycemia rates. Participants were then randomized into the treatment groups in a 2:1 ratio (LY900014:insulin lispro).
    Arm/Group Title Insulin Lispro (Humalog) Lead-in Insulin Lispro (Humalog) LY900014
    Arm/Group Description Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
    Period Title: Lead-In Period
    STARTED 628 0 0
    Participants Who Received at Least One Dose 628 0 0
    COMPLETED 595 0 0
    NOT COMPLETED 33 0 0
    Period Title: Lead-In Period
    STARTED 0 200 395
    Participants Who Received at Least One Dose 0 200 395
    COMPLETED 0 191 359
    NOT COMPLETED 0 9 36

    Baseline Characteristics

    Arm/Group Title Insulin Lispro (Humalog) LY900014 Total
    Arm/Group Description Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. Total of all reporting groups
    Overall Participants 200 395 595
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    58.70
    (9.48)
    58.30
    (9.26)
    58.50
    (9.33)
    Sex: Female, Male (Count of Participants)
    Female
    93
    46.5%
    182
    46.1%
    275
    46.2%
    Male
    107
    53.5%
    213
    53.9%
    320
    53.8%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    5
    2.5%
    11
    2.8%
    16
    2.7%
    Asian
    162
    81%
    319
    80.8%
    481
    80.8%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    White
    29
    14.5%
    53
    13.4%
    82
    13.8%
    More than one race
    4
    2%
    12
    3%
    16
    2.7%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (Count of Participants)
    Argentina
    18
    9%
    32
    8.1%
    50
    8.4%
    China
    162
    81%
    319
    80.8%
    481
    80.8%
    Mexico
    20
    10%
    44
    11.1%
    64
    10.8%
    Hemoglobin A1c (HbA1c) (Percentage of HbA1c) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Percentage of HbA1c]
    7.78
    (0.88)
    7.73
    (0.87)
    7.74
    (0.88)

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in Hemoglobin A1c (HbA1c)
    Description HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Pooled Country + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares).
    Time Frame Baseline, Week 26

    Outcome Measure Data

    Analysis Population Description
    All randomized Participants with baseline and at least one post-baseline HbA1c data.
    Arm/Group Title Insulin Lispro (Humalog) LY900014
    Arm/Group Description Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
    Measure Participants 198 388
    Least Squares Mean (Standard Error) [Percentage of HbA1c]
    -0.63
    (0.061)
    -0.56
    (0.046)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority margin = 0.4% for HbA1c
    Statistical Test of Hypothesis p-Value 0.321
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.07
    Confidence Interval (2-Sided) 95%
    -0.07 to 0.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT)
    Description A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares).
    Time Frame Week 26

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline and at least one post-baseline 1-hour PPG excursion data.
    Arm/Group Title Insulin Lispro (Humalog) LY900014
    Arm/Group Description Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
    Measure Participants 178 326
    Least Squares Mean (Standard Error) [milligrams per deciliter (mg/dL)]
    100.8
    (4.00)
    86.2
    (3.51)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -14.6
    Confidence Interval (2-Sided) 95%
    -21.9 to -7.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title 2-hour PPG Excursion During MMTT
    Description A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares).
    Time Frame Week 26

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline and at least one post-baseline 2-hour PPG excursion data.
    Arm/Group Title Insulin Lispro (Humalog) LY900014
    Arm/Group Description Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
    Measure Participants 179 327
    Least Squares Mean (Standard Error) [mg/dL]
    133.2
    (5.13)
    111.4
    (4.47)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -21.8
    Confidence Interval (2-Sided) 95%
    -30.9 to -12.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Rate of Severe Hypoglycemia
    Description Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within that treatment group *36525.
    Time Frame Baseline through Week 26

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug.
    Arm/Group Title Insulin Lispro (Humalog) LY900014
    Arm/Group Description Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
    Measure Participants 200 395
    Number [Events per 100 participant years]
    2.00
    0.52
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Relative rate
    Estimated Value 0.26
    Confidence Interval (2-Sided) 95%
    0.02 to 2.86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Rate of Documented Symptomatic Postmeal Hypoglycemia
    Description Documented symptomatic postmeal hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of ≤70 mg/dL [3.9 millimole per liter (mmol/L)]. The rate of documented symptomatic postmeal hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable
    Time Frame Baseline through Week 26

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug.
    Arm/Group Title Insulin Lispro (Humalog) LY900014
    Arm/Group Description Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
    Measure Participants 200 395
    ≤30 minutes post meal
    0.13
    (0.033)
    0.11
    (0.020)
    ≤1 hour post meal
    0.25
    (0.057)
    0.34
    (0.053)
    >1 to ≤2 hours post meal
    0.67
    (0.109)
    1.07
    (0.145)
    ≤2 hours post meal
    0.92
    (0.137)
    1.41
    (0.169)
    >2 to ≤4 hours post meal
    1.96
    (0.276)
    1.92
    (0.214)
    ≤4 hours post meal
    2.89
    (0.351)
    3.32
    (0.336)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments For ≤30 minutes post meal
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Relative rate
    Estimated Value 0.90
    Confidence Interval (2-Sided) 95%
    0.49 to 1.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments For ≤ 1 hour post meal
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Relative rate
    Estimated Value 1.35
    Confidence Interval (2-Sided) 95%
    0.79 to 2.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments For >1 to ≤2 hours post meal
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Relative rate
    Estimated Value 1.60
    Confidence Interval (2-Sided) 95%
    1.06 to 2.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments For ≤2 hours post meal
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Relative rate
    Estimated Value 1.53
    Confidence Interval (2-Sided) 95%
    1.05 to 2.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments For >2 to ≤4 hours post meal
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Relative rate
    Estimated Value 0.97
    Confidence Interval (2-Sided) 95%
    0.69 to 1.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments For ≤4 hours post meal
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Relative rate
    Estimated Value 1.15
    Confidence Interval (2-Sided) 95%
    0.84 to 1.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Change From Baseline in 1,5-Anhydroglucitol (1,5-AG)
    Description 1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares)
    Time Frame Baseline, Week 26

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline and at least one post-baseline 1,5-AG data.
    Arm/Group Title Insulin Lispro (Humalog) LY900014
    Arm/Group Description Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
    Measure Participants 190 358
    Least Squares Mean (Standard Error) [milligram per liter (mg/L)]
    2.49
    (0.363)
    2.21
    (0.280)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.29
    Confidence Interval (2-Sided) 95%
    -1.10 to 0.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Secondary Outcome
    Title Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
    Description SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares).
    Time Frame Baseline, Week 26

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline and at least one post-baseline SMBG data.
    Arm/Group Title Insulin Lispro (Humalog) LY900014
    Arm/Group Description Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
    Measure Participants 170 331
    Morning Premeal
    2.2
    (2.62)
    4.4
    (2.18)
    Morning 1-hour Postmeal
    -12.9
    (3.77)
    -18.1
    (3.13)
    Morning 2-hour Postmeal
    -15.9
    (3.65)
    -21.3
    (3.02)
    Midday Premeal
    -9.8
    (3.09)
    -5.7
    (2.56)
    Midday 1-hour Postmeal
    -15.2
    (3.52)
    -13.9
    (2.92)
    Midday 2-hour Postmeal
    -24.4
    (3.63)
    -22.5
    (3.02)
    Evening Premeal
    -25.0
    (3.34)
    -10.9
    (2.76)
    Evening 1-hour Postmeal
    -17.6
    (3.65)
    -15.6
    (3.06)
    Evening 2-hour Postmeal
    -22.1
    (3.67)
    -22.3
    (3.05)
    Bedtime
    -22.3
    (3.38)
    -20.7
    (2.82)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments For Morning Premeal
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 2.2
    Confidence Interval (2-Sided) 95%
    -2.8 to 7.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments For Morning 1-hour Postmeal
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -5.3
    Confidence Interval (2-Sided) 95%
    -12.6 to 2.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments For Morning 2-hour Postmeal
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -5.4
    Confidence Interval (2-Sided) 95%
    -12.5 to 1.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments For Midday Premeal
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 4.2
    Confidence Interval (2-Sided) 95%
    -1.8 to 10.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments For Midday 1-hour Postmeal
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.2
    Confidence Interval (2-Sided) 95%
    -5.7 to 8.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments For Midday 2-hour Postmeal
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.9
    Confidence Interval (2-Sided) 95%
    -5.1 to 8.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments For Evening Premeal
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 14.1
    Confidence Interval (2-Sided) 95%
    7.6 to 20.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments For Evening 1-hour Postmeal
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 2.0
    Confidence Interval (2-Sided) 95%
    -5.1 to 9.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments For Evening 2-hour Postmeal
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -7.3 to 6.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments For Bedtime
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.7
    Confidence Interval (2-Sided) 95%
    -4.7 to 8.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    8. Secondary Outcome
    Title Change From Baseline in Insulin Dose
    Description LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares)
    Time Frame Baseline, Week 26

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline and at least one post-baseline basal insulin dose data.
    Arm/Group Title Insulin Lispro (Humalog) LY900014
    Arm/Group Description Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
    Measure Participants 193 369
    Total Daily Insulin Dose
    15.1
    (1.13)
    17.8
    (0.82)
    Daily Basal Insulin Dose
    0.7
    (0.34)
    1.4
    (0.26)
    Daily Prandial Insulin Dose
    14.7
    (1.04)
    16.7
    (0.75)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments For Total Daily Insulin Dose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 2.8
    Confidence Interval (2-Sided) 95%
    0.1 to 5.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments For Daily Basal Insulin Dose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.8
    Confidence Interval (2-Sided) 95%
    0.0 to 1.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments For Daily Prandial Insulin Dose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 2.0
    Confidence Interval (2-Sided) 95%
    -0.5 to 4.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    9. Secondary Outcome
    Title Percentage of Participants With HbA1c <7% and ≤6.5%
    Description Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Only subjects with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.
    Time Frame Week 26

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline and at least one post-baseline HbA1c <7% and ≤6.5% data.
    Arm/Group Title Insulin Lispro (Humalog) LY900014
    Arm/Group Description Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
    Measure Participants 191 358
    HbA1c < 7%
    44.50
    22.3%
    46.65
    11.8%
    HbA1c ≤ 6.5%
    27.23
    13.6%
    27.93
    7.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments For HbA1c < 7%
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.924
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.02
    Confidence Interval (2-Sided) 95%
    0.69 to 1.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Insulin Lispro (Humalog), LY900014
    Comments For HbA1c ≤6.5%
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.908
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.98
    Confidence Interval (2-Sided) 95%
    0.64 to 1.49
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame Up to 30 weeks
    Adverse Event Reporting Description All randomized participants who received at least one dose of study drug.
    Arm/Group Title Insulin Lispro (Humalog) Lead-in Insulin Lispro (Humalog) LY900014
    Arm/Group Description Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. Participants received 100 U/mL insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
    All Cause Mortality
    Insulin Lispro (Humalog) Lead-in Insulin Lispro (Humalog) LY900014
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/628 (0%) 1/200 (0.5%) 0/395 (0%)
    Serious Adverse Events
    Insulin Lispro (Humalog) Lead-in Insulin Lispro (Humalog) LY900014
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 17/628 (2.7%) 15/200 (7.5%) 33/395 (8.4%)
    Blood and lymphatic system disorders
    Anaemia 0/628 (0%) 0 0/200 (0%) 0 1/395 (0.3%) 1
    Cardiac disorders
    Acute myocardial infarction 1/628 (0.2%) 1 1/200 (0.5%) 1 1/395 (0.3%) 1
    Angina unstable 3/628 (0.5%) 3 0/200 (0%) 0 2/395 (0.5%) 2
    Arrhythmia 0/628 (0%) 0 0/200 (0%) 0 1/395 (0.3%) 1
    Arteriosclerosis coronary artery 0/628 (0%) 0 0/200 (0%) 0 3/395 (0.8%) 3
    Cardiac failure 0/628 (0%) 0 0/200 (0%) 0 1/395 (0.3%) 1
    Coronary artery disease 0/628 (0%) 0 1/200 (0.5%) 1 1/395 (0.3%) 1
    Eye disorders
    Cataract 0/628 (0%) 0 1/200 (0.5%) 1 0/395 (0%) 0
    Cataract diabetic 0/628 (0%) 0 0/200 (0%) 0 1/395 (0.3%) 1
    Diabetic retinopathy 1/628 (0.2%) 1 1/200 (0.5%) 1 0/395 (0%) 0
    Vitreous haemorrhage 1/628 (0.2%) 1 0/200 (0%) 0 1/395 (0.3%) 1
    Vitreous opacities 0/628 (0%) 0 1/200 (0.5%) 1 0/395 (0%) 0
    Gastrointestinal disorders
    Anal fistula 0/628 (0%) 0 0/200 (0%) 0 1/395 (0.3%) 1
    Gastritis erosive 0/628 (0%) 0 0/200 (0%) 0 1/395 (0.3%) 1
    Upper gastrointestinal haemorrhage 0/628 (0%) 0 0/200 (0%) 0 1/395 (0.3%) 1
    General disorders
    Mass 1/628 (0.2%) 1 0/200 (0%) 0 0/395 (0%) 0
    Sudden cardiac death 0/628 (0%) 0 1/200 (0.5%) 1 0/395 (0%) 0
    Hepatobiliary disorders
    Cholecystitis acute 1/628 (0.2%) 1 0/200 (0%) 0 0/395 (0%) 0
    Cholecystitis chronic 0/628 (0%) 0 0/200 (0%) 0 1/395 (0.3%) 1
    Infections and infestations
    Herpes zoster 0/628 (0%) 0 0/200 (0%) 0 1/395 (0.3%) 1
    Pneumonia 2/628 (0.3%) 2 0/200 (0%) 0 1/395 (0.3%) 1
    Injury, poisoning and procedural complications
    Concussion 0/628 (0%) 0 0/200 (0%) 0 1/395 (0.3%) 1
    Femoral neck fracture 0/628 (0%) 0 0/200 (0%) 0 1/395 (0.3%) 1
    Foot fracture 0/628 (0%) 0 0/200 (0%) 0 1/395 (0.3%) 1
    Multiple injuries 0/628 (0%) 0 0/200 (0%) 0 1/395 (0.3%) 1
    Metabolism and nutrition disorders
    Diabetic complication 0/628 (0%) 0 0/200 (0%) 0 1/395 (0.3%) 1
    Hypoglycaemia 0/628 (0%) 0 1/200 (0.5%) 1 1/395 (0.3%) 1
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion 0/628 (0%) 0 0/200 (0%) 0 2/395 (0.5%) 2
    Osteonecrosis 1/628 (0.2%) 1 1/200 (0.5%) 1 0/395 (0%) 0
    Spinal osteoarthritis 1/628 (0.2%) 1 0/200 (0%) 0 0/395 (0%) 0
    Nervous system disorders
    Basal ganglia haemorrhage 0/628 (0%) 0 0/200 (0%) 0 1/395 (0.3%) 1
    Brain stem infarction 0/628 (0%) 0 1/200 (0.5%) 1 0/395 (0%) 0
    Cerebellar infarction 0/628 (0%) 0 0/200 (0%) 0 1/395 (0.3%) 1
    Cerebral infarction 2/628 (0.3%) 2 0/200 (0%) 0 4/395 (1%) 4
    Cerebral ischaemia 1/628 (0.2%) 1 0/200 (0%) 0 2/395 (0.5%) 2
    Cerebrovascular disorder 1/628 (0.2%) 1 0/200 (0%) 0 0/395 (0%) 0
    Diabetic neuropathy 0/628 (0%) 0 1/200 (0.5%) 1 0/395 (0%) 0
    Facial paralysis 0/628 (0%) 0 1/200 (0.5%) 1 0/395 (0%) 0
    Hypoglycaemic coma 0/628 (0%) 0 1/200 (0.5%) 1 0/395 (0%) 0
    Lacunar infarction 2/628 (0.3%) 2 0/200 (0%) 0 1/395 (0.3%) 3
    Vertebrobasilar insufficiency 1/628 (0.2%) 1 0/200 (0%) 0 0/395 (0%) 0
    Psychiatric disorders
    Anxiety 0/628 (0%) 0 1/200 (0.5%) 1 0/395 (0%) 0
    Renal and urinary disorders
    Hydronephrosis 0/628 (0%) 0 0/200 (0%) 0 1/395 (0.3%) 1
    Ureterolithiasis 0/628 (0%) 0 0/200 (0%) 0 1/395 (0.3%) 1
    Respiratory, thoracic and mediastinal disorders
    Haemoptysis 0/628 (0%) 0 1/200 (0.5%) 1 0/395 (0%) 0
    Pulmonary mass 0/628 (0%) 0 1/200 (0.5%) 1 0/395 (0%) 0
    Vascular disorders
    Peripheral vascular disorder 0/628 (0%) 0 0/200 (0%) 0 1/395 (0.3%) 1
    Other (Not Including Serious) Adverse Events
    Insulin Lispro (Humalog) Lead-in Insulin Lispro (Humalog) LY900014
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 29/628 (4.6%) 14/200 (7%) 21/395 (5.3%)
    Infections and infestations
    Upper respiratory tract infection 29/628 (4.6%) 31 14/200 (7%) 14 21/395 (5.3%) 23

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email ClinicalTrials.gov@lilly.com
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03952143
    Other Study ID Numbers:
    • 16830
    • I8B-FH-ITSE
    First Posted:
    May 16, 2019
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Jan 1, 2022