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A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 2 Diabetes Mellitus

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: NCT03338010
Recruitment Status : Completed
First Posted : November 9, 2017
Results First Posted : May 25, 2021
Last Update Posted : May 25, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes
Interventions Drug: LY2963016
Drug: Lantus®
Enrollment 536
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LY2963016 Lantus®
Hide Arm/Group Description Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the fasting blood glucose (FBG) ≤ 100 milligram per deciliter (mg/dL) (5.6 millimoles per litre [mmol/L]) while avoiding hypoglycemia. Participants were allowed to continue oral antihyperglycemic medication (OAM). Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM.
Period Title: Overall Study
Started 359 177
Received at Least One Dose of Study Drug 359 177
Completed 336 159
Not Completed 23 18
Reason Not Completed
Withdrawal by Subject             14             8
Lost to Follow-up             4             2
Adverse Event             3             2
Physician Decision             2             2
Non-Compliance with Study Drug             0             3
Protocol Violation             0             1
Arm/Group Title LY2963016 Lantus® Total
Hide Arm/Group Description Insulin naive participants started on 10 U LY2963016 given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue OAM. Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM. Total of all reporting groups
Overall Number of Baseline Participants 359 177 536
Hide Baseline Analysis Population Description
All randomized participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 359 participants 177 participants 536 participants
58.3  (9.6) 59.5  (8.9) 58.7  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 359 participants 177 participants 536 participants
Female 150 79 229
Male 209 98 307
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 359 participants 177 participants 536 participants
American Indian or Alaska Native 0 0 0
Asian 359 177 536
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 0 0 0
White 0 0 0
More than one race 0 0 0
Unknown or Not Reported 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
China Number Analyzed 359 participants 177 participants 536 participants
359 177 536
Baseline Hemoglobin A1c (HbA1c)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of HbA1c
Number Analyzed 359 participants 177 participants 536 participants
8.42  (1.04) 8.39  (0.92) 8.41  (1.00)
[1]
Measure Description: HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.
Duration of Diabetes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 359 participants 177 participants 536 participants
10.09  (5.47) 10.69  (5.94) 10.29  (5.63)
1.Primary Outcome
Title Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 to Lantus®)
Hide Description HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least square (LS) mean was calculated by mixed-effects model for repeated measures (MMRM) with baseline, insulin secretagogues at study entry, treatment, visit and treatment*visit in the model.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had a baseline and at least one non-missing post-baseline HbA1c value.
Arm/Group Title LY2963016 Lantus®
Hide Arm/Group Description:
Insulin naive participants started on 10 U LY2963016 given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue OAM.
Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM.
Overall Number of Participants Analyzed 334 158
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of HbA1c
-1.27  (0.043) -1.23  (0.062)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments 0.40% noninferiority margin was used.
Statistical Test of Hypothesis P-Value 0.545
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.19 to 0.10
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in HbA1c (Lantus® to LY2963016)
Hide Description HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, treatment, visit and treatment*visit in the model.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had a baseline and at least one non-missing post-baseline HbA1c value.
Arm/Group Title LY2963016 Lantus®
Hide Arm/Group Description:
Insulin naive participants started on 10 U LY2963016 given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue OAM.
Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM.
Overall Number of Participants Analyzed 334 158
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of HbA1c
-1.27  (0.043) -1.23  (0.062)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments 0.40% noninferiority margin was used.
Statistical Test of Hypothesis P-Value 0.545
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.19 to 0.10
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values
Hide Description Seven-point SMBG are completed at the following timepoints: Before Morning Meal, 2 Hours After Morning Meal, Before Mid-Day Meal, 2 Hours After Mid-Day Meal, Before Evening Meal, 2 Hours After Evening Meal and Bed Time. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment*time in the model.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had a baseline and at least one non-missing post-baseline SMBG value.
Arm/Group Title LY2963016 Lantus®
Hide Arm/Group Description:
Insulin naive participants started on 10 U LY2963016 given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue OAM.
Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM.
Overall Number of Participants Analyzed 337 159
Least Squares Mean (Standard Error)
Unit of Measure: milligrams per deciliter (mg/dL)
Before Morning Meal Glucose Number Analyzed 337 participants 159 participants
-48.7  (1.09) -49.7  (1.59)
2 Hours After Morning Meal Glucose Number Analyzed 328 participants 155 participants
-56.3  (2.34) -52.7  (3.39)
Before Mid-Day Meal Glucose Number Analyzed 327 participants 156 participants
-43.2  (2.03) -39.9  (2.93)
2 Hours After Mid-Day Meal Glucose Number Analyzed 321 participants 154 participants
-31.0  (2.31) -35.9  (3.33)
Before Evening Meal Glucose Number Analyzed 325 participants 155 participants
-32.1  (2.21) -33.0  (3.19)
2 Hours After Evening Meal Glucose Number Analyzed 320 participants 153 participants
-29.7  (2.46) -32.0  (3.55)
Bedtime Glucose Number Analyzed 309 participants 146 participants
-31.6  (2.35) -33.0  (3.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments Before Morning Meal Glucose
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.602
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-2.8 to 4.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments 2 Hours After Morning Meal Glucose
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.373
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.7
Confidence Interval (2-Sided) 95%
-11.8 to 4.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments Before Mid-Day Meal Glucose
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.351
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.3
Confidence Interval (2-Sided) 95%
-10.3 to 3.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments 2 Hours After Mid-Day Meal Glucose
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.230
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 4.9
Confidence Interval (2-Sided) 95%
-3.1 to 12.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments Before Evening Meal Glucose
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.819
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
-6.7 to 8.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments 2 Hours After Evening Meal Glucose
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.588
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
-6.2 to 10.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments Bedtime Glucose
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.732
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-6.7 to 9.5
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With HbA1c <7% at Week 24
Hide Description The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had a baseline and at least one non-missing post-baseline HbA1c value.
Arm/Group Title LY2963016 Lantus®
Hide Arm/Group Description:
Insulin naive participants started on 10 U LY2963016 given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue OAM.
Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM.
Overall Number of Participants Analyzed 334 158
Measure Type: Number
Unit of Measure: Percentage of participants
43.7 44.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.846
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With HbA1c ≤6.5% at Week 24
Hide Description The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had a baseline and at least one non-missing post-baseline HbA1c value.
Arm/Group Title LY2963016 Lantus®
Hide Arm/Group Description:
Insulin naive participants started on 10 U LY2963016 given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue OAM.
Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM.
Overall Number of Participants Analyzed 334 158
Measure Type: Number
Unit of Measure: Percentage of participants
23.4 16.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.098
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Glycemic Variability of Fasting Blood Glucose
Hide Description Glycemic variability is measured by the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning and daily pre-meal blood glucose value from the 7-point self-monitoring blood glucose [SMBG] profiles. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment*time in the model.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had a baseline and at least one non-missing post-baseline SMBG value.
Arm/Group Title LY2963016 Lantus®
Hide Arm/Group Description:
Insulin naive participants started on 10 U LY2963016 given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue OAM.
Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM.
Overall Number of Participants Analyzed 327 157
Least Squares Mean (Standard Error)
Unit of Measure: milligrams per deciliter (mg/dL)
Morning Pre-meal Standard Deviation Number Analyzed 316 participants 150 participants
-2.17  (0.606) -2.49  (0.879)
Daily Mean Standard Deviation Number Analyzed 327 participants 157 participants
-4.1  (0.85) -4.5  (1.22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments Morning Pre-meal Standard Deviation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.767
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.32
Confidence Interval (2-Sided) 95%
-1.78 to 2.42
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments Daily Mean Standard Deviation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.781
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-2.5 to 3.3
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Basal Insulin Dose Units Per Day
Hide Description Units of basal insulin dose taken per day (U/day). LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment*time in the model.
Time Frame At Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had a baseline and at least one non-missing post-baseline basal Insulin dose value.
Arm/Group Title LY2963016 Lantus®
Hide Arm/Group Description:
Insulin naive participants started on 10 U LY2963016 given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue OAM.
Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM.
Overall Number of Participants Analyzed 341 161
Least Squares Mean (Standard Error)
Unit of Measure: units per day (U/day)
16.0  (0.43) 15.7  (0.61)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.750
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-1.2 to 1.7
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Basal Insulin Dose Units Per Day
Hide Description Units of basal insulin dose taken per day (U/day). LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment*time in the model.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had a baseline and at least one non-missing post-baseline basal Insulin dose value.
Arm/Group Title LY2963016 Lantus®
Hide Arm/Group Description:
Insulin naive participants started on 10 U LY2963016 given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue OAM.
Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM.
Overall Number of Participants Analyzed 341 161
Least Squares Mean (Standard Error)
Unit of Measure: U/day
7.0  (0.43) 6.8  (0.61)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.750
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-1.2 to 1.7
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Body Weight
Hide Description Change from baseline in body weight was evaluated. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment*time in the model.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable baseline and at least one non-missing post-baseline body weight data.
Arm/Group Title LY2963016 Lantus®
Hide Arm/Group Description:
Insulin naive participants started on 10 U LY2963016 given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue OAM.
Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM.
Overall Number of Participants Analyzed 334 158
Least Squares Mean (Standard Error)
Unit of Measure: kilogram (kg)
1.1  (0.13) 1.2  (0.19)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.6 to 0.3
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Insulin Treatment Satisfaction Questionnaire (ITSQ)
Hide Description ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items divided into 5 domains of satisfaction: Inconvenience of Regimen [(IR) 5 items: domain scores range (DSR) 5-35], Lifestyle Flexibility [(LF) 3 items: DSR 3-21], Glycemic Control [(GC) 3 items: DSR 3-21], Hypoglycemic Control [(HC) 5 items: DSR 5-35], Insulin Delivery Device [(IDD) 6 items: DSR 6-42]. All items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. ITSQ Total Overall Raw Scores range from 22-154. Both raw domain and overall scores are transformed on a scale of 0-100, where transformed score=100*[(7-mean raw score)/6]. Higher scores indicate better treatment satisfaction. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment*time in the model.
Time Frame At Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had evaluable ITSQ data.
Arm/Group Title LY2963016 Lantus®
Hide Arm/Group Description:
Insulin naive participants started on 10 U LY2963016 given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue OAM.
Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM.
Overall Number of Participants Analyzed 334 158
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
IR 89.36  (0.80) 90.31  (1.16)
LF 83.70  (1.05) 87.69  (1.52)
HC 89.07  (0.79) 90.86  (1.15)
GC 87.80  (0.84) 87.83  (1.21)
IDD 86.84  (0.86) 88.29  (1.24)
ITSQ Overall Total 87.32  (0.75) 88.99  (1.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments Inconvenience of Regimen Transformed Score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.500
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.95
Confidence Interval (2-Sided) 95%
-3.72 to 1.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments Lifestyle Flexibility Transformed Score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.99
Confidence Interval (2-Sided) 95%
-7.62 to -0.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments Hypoglycemic Control Transformed Score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.200
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.79
Confidence Interval (2-Sided) 95%
-4.53 to 0.95
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments Glycemic Control Transformed Score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.988
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-2.92 to 2.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments Insulin Delivery Device Satisfaction Transformed Score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.337
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.45
Confidence Interval (2-Sided) 95%
-4.41 to 1.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments ITSQ Overall Total
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.205
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.67
Confidence Interval (2-Sided) 95%
-4.26 to 0.92
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Number of Participants With Detectable Anti-Glargine Antibodies
Hide Description Number of participants with detectable anti-glargine antibodies were reported.
Time Frame Baseline through 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug. Only participants with detected insulin antibody levels at baseline and at least one non-missing post-baseline were included in analysis.
Arm/Group Title LY2963016 Lantus®
Hide Arm/Group Description:
Insulin naive participants started on 10 U LY2963016 given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue OAM.
Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM.
Overall Number of Participants Analyzed 357 177
Measure Type: Number
Unit of Measure: participants
69 31
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.639
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
12.Secondary Outcome
Title Rate of Total Symptomatic and Nocturnal Hypoglycemia Events (Adjusted by 1 Year)
Hide Description Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). The overall yearly rates (events/participant/year) of those hypoglycemic events, calculated as, for each participant, the number of episodes times 365.25 and then divided by the participants treatment duration, will be summarized, and analyzed by a negative-binomial regression model with treatment as fixed effects and log of (participant's treatment duration/365.25) as an offset variable. A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking.
Time Frame Baseline through 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable baseline and at least one non-missing post-baseline hypoglycemic event.
Arm/Group Title LY2963016 Lantus®
Hide Arm/Group Description:
Insulin naive participants started on 10 U LY2963016 given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue OAM.
Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM.
Overall Number of Participants Analyzed 359 177
Least Squares Mean (Standard Error)
Unit of Measure: events/participant/year
Total hypoglycemia 1.37  (0.228) 1.15  (0.280)
Nocturnal Hypoglycemia 0.47  (0.132) 0.39  (0.110)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.143
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Ratio
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
0.74 to 1.92
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY2963016, Lantus®
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.945
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Ratio
Estimated Value 1.22
Confidence Interval (2-Sided) 95%
0.67 to 2.23
Estimation Comments [Not Specified]
Time Frame Baseline Up To 28 Weeks
Adverse Event Reporting Description All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
 
Arm/Group Title LY2963016 Lantus®
Hide Arm/Group Description Insulin naive participants started on 10 U LY2963016 given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue OAM. Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM.
All-Cause Mortality
LY2963016 Lantus®
Affected / at Risk (%) Affected / at Risk (%)
Total   0/359 (0.00%)      0/177 (0.00%)    
Hide Serious Adverse Events
LY2963016 Lantus®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/359 (7.80%)      14/177 (7.91%)    
Blood and lymphatic system disorders     
Anaemia † 1  0/359 (0.00%)  0 1/177 (0.56%)  1
Cardiac disorders     
Acute coronary syndrome † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Angina unstable † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Cardiac failure congestive † 1  0/359 (0.00%)  0 1/177 (0.56%)  1
Coronary artery disease † 1  1/359 (0.28%)  1 1/177 (0.56%)  1
Ear and labyrinth disorders     
Sudden hearing loss † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Eye disorders     
Cataract † 1  2/359 (0.56%)  2 0/177 (0.00%)  0
Malignant glaucoma † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Gastrointestinal disorders     
Colitis † 1  0/359 (0.00%)  0 1/177 (0.56%)  1
Gastrointestinal polyp † 1  0/359 (0.00%)  0 1/177 (0.56%)  1
Haemorrhoids † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Large intestine polyp † 1  1/359 (0.28%)  1 1/177 (0.56%)  1
Infections and infestations     
Central nervous system infection † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Gastroenteritis † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Hepatitis e † 1  0/359 (0.00%)  0 1/177 (0.56%)  1
Herpes zoster † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Pneumonia † 1  3/359 (0.84%)  3 1/177 (0.56%)  1
Soft tissue infection † 1  1/359 (0.28%)  1 1/177 (0.56%)  1
Urinary tract infection † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Injury, poisoning and procedural complications     
Facial bones fracture † 1  1/359 (0.28%)  1 1/177 (0.56%)  1
Femoral neck fracture † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Fibula fracture † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Foot fracture † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Rib fracture † 1  0/359 (0.00%)  0 1/177 (0.56%)  1
Skin laceration † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Sternal fracture † 1  0/359 (0.00%)  0 1/177 (0.56%)  1
Metabolism and nutrition disorders     
Hypochloraemia † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Hypokalaemia † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Hyponatraemia † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Pain in extremity † 1  0/359 (0.00%)  0 1/177 (0.56%)  1
Spinal osteoarthritis † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Lung neoplasm malignant † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Nervous system disorders     
Carotid artery stenosis † 1  0/359 (0.00%)  0 1/177 (0.56%)  1
Cerebral infarction † 1  5/359 (1.39%)  6 2/177 (1.13%)  2
Renal and urinary disorders     
Calculus urethral † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Hydronephrosis † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Nephrolithiasis † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Ureterolithiasis † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma † 1  1/359 (0.28%)  1 0/177 (0.00%)  0
Vascular disorders     
Hypertension † 1  0/359 (0.00%)  0 1/177 (0.56%)  1
Varicose vein † 1  0/359 (0.00%)  0 1/177 (0.56%)  1
1
Term from vocabulary, MedDRA 22.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
LY2963016 Lantus®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   194/359 (54.04%)      95/177 (53.67%)    
Blood and lymphatic system disorders     
Thrombocytopenia † 1  2/359 (0.56%)  2 3/177 (1.69%)  3
Cardiac disorders     
Angina pectoris † 1  2/359 (0.56%)  3 2/177 (1.13%)  3
Supraventricular extrasystoles † 1  1/359 (0.28%)  1 2/177 (1.13%)  2
Endocrine disorders     
Autoimmune thyroiditis † 1  0/359 (0.00%)  0 2/177 (1.13%)  2
Hypothyroidism † 1  4/359 (1.11%)  4 1/177 (0.56%)  2
Eye disorders     
Cataract † 1  5/359 (1.39%)  6 0/177 (0.00%)  0
Gastrointestinal disorders     
Abdominal discomfort † 1  0/359 (0.00%)  0 2/177 (1.13%)  2
Abdominal pain upper † 1  4/359 (1.11%)  4 0/177 (0.00%)  0
Constipation † 1  6/359 (1.67%)  6 3/177 (1.69%)  3
Diarrhoea † 1  10/359 (2.79%)  14 4/177 (2.26%)  4
Nausea † 1  4/359 (1.11%)  8 3/177 (1.69%)  3
Toothache † 1  9/359 (2.51%)  11 1/177 (0.56%)  1
Vomiting † 1  4/359 (1.11%)  4 1/177 (0.56%)  1
General disorders     
Chest discomfort † 1  2/359 (0.56%)  2 3/177 (1.69%)  3
Chest pain † 1  7/359 (1.95%)  7 2/177 (1.13%)  2
Hunger † 1  2/359 (0.56%)  3 2/177 (1.13%)  2
Injection site pain † 1  15/359 (4.18%)  19 5/177 (2.82%)  5
Injection site pruritus † 1  4/359 (1.11%)  5 1/177 (0.56%)  1
Injection site rash † 1  4/359 (1.11%)  7 1/177 (0.56%)  1
Oedema peripheral † 1  1/359 (0.28%)  1 3/177 (1.69%)  3
Pyrexia † 1  4/359 (1.11%)  4 1/177 (0.56%)  1
Hepatobiliary disorders     
Cholelithiasis † 1  0/359 (0.00%)  0 2/177 (1.13%)  2
Hepatic function abnormal † 1  3/359 (0.84%)  3 3/177 (1.69%)  3
Hepatic steatosis † 1  3/359 (0.84%)  3 4/177 (2.26%)  4
Infections and infestations     
Bronchitis † 1  3/359 (0.84%)  3 6/177 (3.39%)  6
Gastroenteritis † 1  4/359 (1.11%)  5 2/177 (1.13%)  2
Nasopharyngitis † 1  8/359 (2.23%)  8 7/177 (3.95%)  7
Otitis media † 1  1/359 (0.28%)  1 2/177 (1.13%)  2
Periodontitis † 1  3/359 (0.84%)  4 4/177 (2.26%)  5
Pharyngitis † 1  9/359 (2.51%)  9 2/177 (1.13%)  2
Pneumonia † 1  2/359 (0.56%)  2 3/177 (1.69%)  4
Pulpitis dental † 1  1/359 (0.28%)  1 2/177 (1.13%)  2
Respiratory tract infection † 1  5/359 (1.39%)  6 0/177 (0.00%)  0
Upper respiratory tract infection † 1  73/359 (20.33%)  80 32/177 (18.08%)  38
Urinary tract infection † 1  2/359 (0.56%)  2 3/177 (1.69%)  3
Vaginal infection † 1  1/150 (0.67%)  1 1/79 (1.27%)  1
Injury, poisoning and procedural complications     
Head injury † 1  0/359 (0.00%)  0 2/177 (1.13%)  2
Limb injury † 1  2/359 (0.56%)  2 2/177 (1.13%)  2
Investigations     
Blood pressure increased † 1  4/359 (1.11%)  4 1/177 (0.56%)  1
Protein urine present † 1  0/359 (0.00%)  0 2/177 (1.13%)  2
Weight increased † 1  14/359 (3.90%)  14 11/177 (6.21%)  11
Metabolism and nutrition disorders     
Hyperlipidaemia † 1  2/359 (0.56%)  2 2/177 (1.13%)  2
Hypokalaemia † 1  4/359 (1.11%)  6 1/177 (0.56%)  1
Hypoproteinaemia † 1  1/359 (0.28%)  1 2/177 (1.13%)  2
Musculoskeletal and connective tissue disorders     
Back pain † 1  5/359 (1.39%)  5 2/177 (1.13%)  2
Joint effusion † 1  1/359 (0.28%)  3 2/177 (1.13%)  3
Osteoarthritis † 1  2/359 (0.56%)  2 3/177 (1.69%)  3
Pain in extremity † 1  2/359 (0.56%)  2 2/177 (1.13%)  2
Periarthritis † 1  6/359 (1.67%)  6 1/177 (0.56%)  1
Spinal osteoarthritis † 1  5/359 (1.39%)  6 2/177 (1.13%)  5
Synovial cyst † 1  0/359 (0.00%)  0 2/177 (1.13%)  2
Nervous system disorders     
Carotid arteriosclerosis † 1  0/359 (0.00%)  0 2/177 (1.13%)  3
Diabetic neuropathy † 1  1/359 (0.28%)  1 5/177 (2.82%)  5
Dizziness † 1  8/359 (2.23%)  10 3/177 (1.69%)  3
Hypoaesthesia † 1  2/359 (0.56%)  2 2/177 (1.13%)  2
Psychiatric disorders     
Anxiety † 1  1/359 (0.28%)  1 2/177 (1.13%)  2
Depression † 1  0/359 (0.00%)  0 2/177 (1.13%)  2
Insomnia † 1  3/359 (0.84%)  3 4/177 (2.26%)  4
Renal and urinary disorders     
Nephrolithiasis † 1  1/359 (0.28%)  1 2/177 (1.13%)  2
Renal cyst † 1  3/359 (0.84%)  3 4/177 (2.26%)  4
Ureterolithiasis † 1  2/359 (0.56%)  2 2/177 (1.13%)  2
Reproductive system and breast disorders     
Balanoposthitis † 1  0/209 (0.00%)  0 1/98 (1.02%)  1
Prostatic calcification † 1  0/209 (0.00%)  0 1/98 (1.02%)  1
Uterine atrophy † 1  0/150 (0.00%)  0 1/79 (1.27%)  1
Respiratory, thoracic and mediastinal disorders     
Cough † 1  13/359 (3.62%)  16 5/177 (2.82%)  5
Oropharyngeal pain † 1  3/359 (0.84%)  4 4/177 (2.26%)  4
Pulmonary mass † 1  2/359 (0.56%)  2 2/177 (1.13%)  2
Skin and subcutaneous tissue disorders     
Pruritus † 1  4/359 (1.11%)  4 0/177 (0.00%)  0
Rash † 1  1/359 (0.28%)  1 2/177 (1.13%)  2
Vascular disorders     
Aortic arteriosclerosis † 1  1/359 (0.28%)  1 2/177 (1.13%)  2
Arteriosclerosis † 1  3/359 (0.84%)  3 2/177 (1.13%)  3
Diabetic vascular disorder † 1  0/359 (0.00%)  0 2/177 (1.13%)  2
Hypertension † 1  20/359 (5.57%)  20 7/177 (3.95%)  8
1
Term from vocabulary, MedDRA 22.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: ClinicalTrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03338010    
Other Study ID Numbers: 16037
I4L-GH-ABET ( Other Identifier: Eli Lilly and Company )
First Submitted: November 7, 2017
First Posted: November 9, 2017
Results First Submitted: March 15, 2021
Results First Posted: May 25, 2021
Last Update Posted: May 25, 2021