Trial Outcomes & Findings for A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 2 Diabetes Mellitus (NCT NCT03338010)

NCT ID: NCT03338010

Last Updated: 2021-05-25

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 536 participants
• Primary outcome timeframe: Baseline, Week 24
• Results posted on: 2021-05-25

Participant Flow

Participant milestones

Measure	LY2963016 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).	Lantus® 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 Study STARTED	359	177
Overall Study Received at Least One Dose of Study Drug	359	177
Overall Study COMPLETED	336	159
Overall Study NOT COMPLETED	23	18

Reasons for withdrawal

Measure	LY2963016 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).	Lantus® 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 Study Withdrawal by Subject	14	8
Overall Study Lost to Follow-up	4	2
Overall Study Adverse Event	3	2
Overall Study Physician Decision	2	2
Overall Study Non-Compliance with Study Drug	0	3
Overall Study Protocol Violation	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	LY2963016 n=359 Participants 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.	Lantus® n=177 Participants 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 n=536 Participants Total of all reporting groups
Age, Continuous	58.3 years STANDARD_DEVIATION 9.6 • n=5 Participants	59.5 years STANDARD_DEVIATION 8.9 • n=7 Participants	58.7 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	150 Participants n=5 Participants	79 Participants n=7 Participants	229 Participants n=5 Participants
Sex: Female, Male Male	209 Participants n=5 Participants	98 Participants n=7 Participants	307 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	359 Participants n=5 Participants	177 Participants n=7 Participants	536 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment China	359 Participants n=5 Participants	177 Participants n=7 Participants	536 Participants n=5 Participants
Baseline Hemoglobin A1c (HbA1c)	8.42 Percentage of HbA1c STANDARD_DEVIATION 1.04 • n=5 Participants	8.39 Percentage of HbA1c STANDARD_DEVIATION 0.92 • n=7 Participants	8.41 Percentage of HbA1c STANDARD_DEVIATION 1.00 • n=5 Participants
Duration of Diabetes	10.09 years STANDARD_DEVIATION 5.47 • n=5 Participants	10.69 years STANDARD_DEVIATION 5.94 • n=7 Participants	10.29 years STANDARD_DEVIATION 5.63 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	LY2963016 n=334 Participants 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.	Lantus® n=158 Participants 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.
Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 to Lantus®)	-1.27 Percentage of HbA1c Standard Error 0.043	-1.23 Percentage of HbA1c Standard Error 0.062

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	LY2963016 n=334 Participants 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.	Lantus® n=158 Participants 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.
Change From Baseline in HbA1c (Lantus® to LY2963016)	-1.27 Percentage of HbA1c Standard Error 0.043	-1.23 Percentage of HbA1c Standard Error 0.062

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	LY2963016 n=337 Participants 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.	Lantus® n=159 Participants 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.
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values Before Morning Meal Glucose	-48.7 milligrams per deciliter (mg/dL) Standard Error 1.09	-49.7 milligrams per deciliter (mg/dL) Standard Error 1.59
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values 2 Hours After Morning Meal Glucose	-56.3 milligrams per deciliter (mg/dL) Standard Error 2.34	-52.7 milligrams per deciliter (mg/dL) Standard Error 3.39
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values Before Mid-Day Meal Glucose	-43.2 milligrams per deciliter (mg/dL) Standard Error 2.03	-39.9 milligrams per deciliter (mg/dL) Standard Error 2.93
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values 2 Hours After Mid-Day Meal Glucose	-31.0 milligrams per deciliter (mg/dL) Standard Error 2.31	-35.9 milligrams per deciliter (mg/dL) Standard Error 3.33
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values Before Evening Meal Glucose	-32.1 milligrams per deciliter (mg/dL) Standard Error 2.21	-33.0 milligrams per deciliter (mg/dL) Standard Error 3.19
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values 2 Hours After Evening Meal Glucose	-29.7 milligrams per deciliter (mg/dL) Standard Error 2.46	-32.0 milligrams per deciliter (mg/dL) Standard Error 3.55
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values Bedtime Glucose	-31.6 milligrams per deciliter (mg/dL) Standard Error 2.35	-33.0 milligrams per deciliter (mg/dL) Standard Error 3.40

SECONDARY outcome

Timeframe: Week 24

Population: 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.

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.

Outcome measures

Measure	LY2963016 n=334 Participants 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.	Lantus® n=158 Participants 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.
Percentage of Participants With HbA1c <7% at Week 24	43.7 Percentage of participants	44.9 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: 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.

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.

Outcome measures

Measure	LY2963016 n=334 Participants 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.	Lantus® n=158 Participants 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.
Percentage of Participants With HbA1c ≤6.5% at Week 24	23.4 Percentage of participants	16.5 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	LY2963016 n=327 Participants 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.	Lantus® n=157 Participants 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.
Change From Baseline in Glycemic Variability of Fasting Blood Glucose Morning Pre-meal Standard Deviation	-2.17 milligrams per deciliter (mg/dL) Standard Error 0.606	-2.49 milligrams per deciliter (mg/dL) Standard Error 0.879
Change From Baseline in Glycemic Variability of Fasting Blood Glucose Daily Mean Standard Deviation	-4.1 milligrams per deciliter (mg/dL) Standard Error 0.85	-4.5 milligrams per deciliter (mg/dL) Standard Error 1.22

SECONDARY outcome

Timeframe: At Week 24

Population: 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.

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.

Outcome measures

Measure	LY2963016 n=341 Participants 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.	Lantus® n=161 Participants 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.
Basal Insulin Dose Units Per Day	16.0 units per day (U/day) Standard Error 0.43	15.7 units per day (U/day) Standard Error 0.61

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	LY2963016 n=341 Participants 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.	Lantus® n=161 Participants 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.
Change From Baseline in Basal Insulin Dose Units Per Day	7.0 U/day Standard Error 0.43	6.8 U/day Standard Error 0.61

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	LY2963016 n=334 Participants 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.	Lantus® n=158 Participants 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.
Change From Baseline in Body Weight	1.1 kilogram (kg) Standard Error 0.13	1.2 kilogram (kg) Standard Error 0.19

SECONDARY outcome

Timeframe: At Week 24

Population: All randomized participants who received at least 1 dose of study drug and had evaluable ITSQ data.

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.

Outcome measures

Measure	LY2963016 n=334 Participants 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.	Lantus® n=158 Participants 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.
Insulin Treatment Satisfaction Questionnaire (ITSQ) IR	89.36 units on a scale Standard Error 0.80	90.31 units on a scale Standard Error 1.16
Insulin Treatment Satisfaction Questionnaire (ITSQ) LF	83.70 units on a scale Standard Error 1.05	87.69 units on a scale Standard Error 1.52
Insulin Treatment Satisfaction Questionnaire (ITSQ) HC	89.07 units on a scale Standard Error 0.79	90.86 units on a scale Standard Error 1.15
Insulin Treatment Satisfaction Questionnaire (ITSQ) GC	87.80 units on a scale Standard Error 0.84	87.83 units on a scale Standard Error 1.21
Insulin Treatment Satisfaction Questionnaire (ITSQ) IDD	86.84 units on a scale Standard Error 0.86	88.29 units on a scale Standard Error 1.24
Insulin Treatment Satisfaction Questionnaire (ITSQ) ITSQ Overall Total	87.32 units on a scale Standard Error 0.75	88.99 units on a scale Standard Error 1.08

SECONDARY outcome

Timeframe: Baseline through 24 weeks

Population: 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.

Number of participants with detectable anti-glargine antibodies were reported.

Outcome measures

Measure	LY2963016 n=357 Participants 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.	Lantus® n=177 Participants 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.
Number of Participants With Detectable Anti-Glargine Antibodies	69 participants	31 participants

SECONDARY outcome

Timeframe: Baseline through 24 weeks

Population: 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.

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.

Outcome measures

Measure	LY2963016 n=359 Participants 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.	Lantus® n=177 Participants 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.
Rate of Total Symptomatic and Nocturnal Hypoglycemia Events (Adjusted by 1 Year) Total hypoglycemia	1.37 events/participant/year Standard Error 0.228	1.15 events/participant/year Standard Error 0.280
Rate of Total Symptomatic and Nocturnal Hypoglycemia Events (Adjusted by 1 Year) Nocturnal Hypoglycemia	0.47 events/participant/year Standard Error 0.132	0.39 events/participant/year Standard Error 0.110

Adverse Events

LY2963016

Serious events: 28 serious events

Other events: 194 other events

Deaths: 0 deaths

Lantus®

Serious events: 14 serious events

Other events: 95 other events

Deaths: 0 deaths

Serious adverse events

Measure	LY2963016 n=359 participants at risk 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.	Lantus® n=177 participants at risk 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.
Blood and lymphatic system disorders Anaemia	0.00% 0/359 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.
Cardiac disorders Acute coronary syndrome	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Cardiac disorders Angina unstable	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Cardiac disorders Cardiac failure congestive	0.00% 0/359 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.
Cardiac disorders Coronary artery disease	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.
Ear and labyrinth disorders Sudden hearing loss	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Eye disorders Cataract	0.56% 2/359 • Number of events 2 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Eye disorders Malignant glaucoma	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Gastrointestinal disorders Colitis	0.00% 0/359 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.
Gastrointestinal disorders Gastrointestinal polyp	0.00% 0/359 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.
Gastrointestinal disorders Haemorrhoids	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Gastrointestinal disorders Large intestine polyp	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.
Infections and infestations Central nervous system infection	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Infections and infestations Gastroenteritis	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Infections and infestations Hepatitis e	0.00% 0/359 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.
Infections and infestations Herpes zoster	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Infections and infestations Pneumonia	0.84% 3/359 • Number of events 3 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.
Infections and infestations Soft tissue infection	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.
Infections and infestations Urinary tract infection	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Injury, poisoning and procedural complications Facial bones fracture	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.
Injury, poisoning and procedural complications Femoral neck fracture	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Injury, poisoning and procedural complications Fibula fracture	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Injury, poisoning and procedural complications Foot fracture	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/359 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.
Injury, poisoning and procedural complications Skin laceration	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/359 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.
Metabolism and nutrition disorders Hypochloraemia	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Metabolism and nutrition disorders Hypokalaemia	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Metabolism and nutrition disorders Hyponatraemia	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/359 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Nervous system disorders Carotid artery stenosis	0.00% 0/359 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.
Nervous system disorders Cerebral infarction	1.4% 5/359 • Number of events 6 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Renal and urinary disorders Calculus urethral	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Renal and urinary disorders Hydronephrosis	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Renal and urinary disorders Nephrolithiasis	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Renal and urinary disorders Ureterolithiasis	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Respiratory, thoracic and mediastinal disorders Asthma	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Vascular disorders Hypertension	0.00% 0/359 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.
Vascular disorders Varicose vein	0.00% 0/359 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.

Other adverse events

Measure	LY2963016 n=359 participants at risk 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.	Lantus® n=177 participants at risk 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.
Blood and lymphatic system disorders Thrombocytopenia	0.56% 2/359 • Number of events 2 • Baseline Up To 28 Weeks 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.	1.7% 3/177 • Number of events 3 • Baseline Up To 28 Weeks 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.
Cardiac disorders Angina pectoris	0.56% 2/359 • Number of events 3 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 3 • Baseline Up To 28 Weeks 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.
Cardiac disorders Supraventricular extrasystoles	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Endocrine disorders Autoimmune thyroiditis	0.00% 0/359 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Endocrine disorders Hypothyroidism	1.1% 4/359 • Number of events 4 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Eye disorders Cataract	1.4% 5/359 • Number of events 6 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/359 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Gastrointestinal disorders Abdominal pain upper	1.1% 4/359 • Number of events 4 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Gastrointestinal disorders Constipation	1.7% 6/359 • Number of events 6 • Baseline Up To 28 Weeks 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.	1.7% 3/177 • Number of events 3 • Baseline Up To 28 Weeks 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.
Gastrointestinal disorders Diarrhoea	2.8% 10/359 • Number of events 14 • Baseline Up To 28 Weeks 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.	2.3% 4/177 • Number of events 4 • Baseline Up To 28 Weeks 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.
Gastrointestinal disorders Nausea	1.1% 4/359 • Number of events 8 • Baseline Up To 28 Weeks 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.	1.7% 3/177 • Number of events 3 • Baseline Up To 28 Weeks 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.
Gastrointestinal disorders Toothache	2.5% 9/359 • Number of events 11 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.
Gastrointestinal disorders Vomiting	1.1% 4/359 • Number of events 4 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.
General disorders Chest discomfort	0.56% 2/359 • Number of events 2 • Baseline Up To 28 Weeks 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.	1.7% 3/177 • Number of events 3 • Baseline Up To 28 Weeks 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.
General disorders Chest pain	1.9% 7/359 • Number of events 7 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
General disorders Hunger	0.56% 2/359 • Number of events 3 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
General disorders Injection site pain	4.2% 15/359 • Number of events 19 • Baseline Up To 28 Weeks 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.	2.8% 5/177 • Number of events 5 • Baseline Up To 28 Weeks 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.
General disorders Injection site pruritus	1.1% 4/359 • Number of events 5 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.
General disorders Injection site rash	1.1% 4/359 • Number of events 7 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.
General disorders Oedema peripheral	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	1.7% 3/177 • Number of events 3 • Baseline Up To 28 Weeks 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.
General disorders Pyrexia	1.1% 4/359 • Number of events 4 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.
Hepatobiliary disorders Cholelithiasis	0.00% 0/359 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Hepatobiliary disorders Hepatic function abnormal	0.84% 3/359 • Number of events 3 • Baseline Up To 28 Weeks 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.	1.7% 3/177 • Number of events 3 • Baseline Up To 28 Weeks 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.
Hepatobiliary disorders Hepatic steatosis	0.84% 3/359 • Number of events 3 • Baseline Up To 28 Weeks 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.	2.3% 4/177 • Number of events 4 • Baseline Up To 28 Weeks 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.
Infections and infestations Bronchitis	0.84% 3/359 • Number of events 3 • Baseline Up To 28 Weeks 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.	3.4% 6/177 • Number of events 6 • Baseline Up To 28 Weeks 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.
Infections and infestations Gastroenteritis	1.1% 4/359 • Number of events 5 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Infections and infestations Nasopharyngitis	2.2% 8/359 • Number of events 8 • Baseline Up To 28 Weeks 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.	4.0% 7/177 • Number of events 7 • Baseline Up To 28 Weeks 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.
Infections and infestations Otitis media	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Infections and infestations Periodontitis	0.84% 3/359 • Number of events 4 • Baseline Up To 28 Weeks 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.	2.3% 4/177 • Number of events 5 • Baseline Up To 28 Weeks 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.
Infections and infestations Pharyngitis	2.5% 9/359 • Number of events 9 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Infections and infestations Pneumonia	0.56% 2/359 • Number of events 2 • Baseline Up To 28 Weeks 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.	1.7% 3/177 • Number of events 4 • Baseline Up To 28 Weeks 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.
Infections and infestations Pulpitis dental	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Infections and infestations Respiratory tract infection	1.4% 5/359 • Number of events 6 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Infections and infestations Upper respiratory tract infection	20.3% 73/359 • Number of events 80 • Baseline Up To 28 Weeks 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.	18.1% 32/177 • Number of events 38 • Baseline Up To 28 Weeks 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.
Infections and infestations Urinary tract infection	0.56% 2/359 • Number of events 2 • Baseline Up To 28 Weeks 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.	1.7% 3/177 • Number of events 3 • Baseline Up To 28 Weeks 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.
Infections and infestations Vaginal infection	0.67% 1/150 • Number of events 1 • Baseline Up To 28 Weeks 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.	1.3% 1/79 • Number of events 1 • Baseline Up To 28 Weeks 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.
Injury, poisoning and procedural complications Head injury	0.00% 0/359 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Injury, poisoning and procedural complications Limb injury	0.56% 2/359 • Number of events 2 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Investigations Blood pressure increased	1.1% 4/359 • Number of events 4 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.
Investigations Protein urine present	0.00% 0/359 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Investigations Weight increased	3.9% 14/359 • Number of events 14 • Baseline Up To 28 Weeks 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.	6.2% 11/177 • Number of events 11 • Baseline Up To 28 Weeks 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.
Metabolism and nutrition disorders Hyperlipidaemia	0.56% 2/359 • Number of events 2 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Metabolism and nutrition disorders Hypokalaemia	1.1% 4/359 • Number of events 6 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.
Metabolism and nutrition disorders Hypoproteinaemia	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Musculoskeletal and connective tissue disorders Back pain	1.4% 5/359 • Number of events 5 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Musculoskeletal and connective tissue disorders Joint effusion	0.28% 1/359 • Number of events 3 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 3 • Baseline Up To 28 Weeks 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.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.56% 2/359 • Number of events 2 • Baseline Up To 28 Weeks 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.	1.7% 3/177 • Number of events 3 • Baseline Up To 28 Weeks 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.
Musculoskeletal and connective tissue disorders Pain in extremity	0.56% 2/359 • Number of events 2 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Musculoskeletal and connective tissue disorders Periarthritis	1.7% 6/359 • Number of events 6 • Baseline Up To 28 Weeks 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.	0.56% 1/177 • Number of events 1 • Baseline Up To 28 Weeks 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.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	1.4% 5/359 • Number of events 6 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 5 • Baseline Up To 28 Weeks 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.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/359 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Nervous system disorders Carotid arteriosclerosis	0.00% 0/359 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 3 • Baseline Up To 28 Weeks 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.
Nervous system disorders Diabetic neuropathy	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	2.8% 5/177 • Number of events 5 • Baseline Up To 28 Weeks 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.
Nervous system disorders Dizziness	2.2% 8/359 • Number of events 10 • Baseline Up To 28 Weeks 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.	1.7% 3/177 • Number of events 3 • Baseline Up To 28 Weeks 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.
Nervous system disorders Hypoaesthesia	0.56% 2/359 • Number of events 2 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Psychiatric disorders Anxiety	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Psychiatric disorders Depression	0.00% 0/359 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Psychiatric disorders Insomnia	0.84% 3/359 • Number of events 3 • Baseline Up To 28 Weeks 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.	2.3% 4/177 • Number of events 4 • Baseline Up To 28 Weeks 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.
Renal and urinary disorders Nephrolithiasis	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Renal and urinary disorders Renal cyst	0.84% 3/359 • Number of events 3 • Baseline Up To 28 Weeks 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.	2.3% 4/177 • Number of events 4 • Baseline Up To 28 Weeks 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.
Renal and urinary disorders Ureterolithiasis	0.56% 2/359 • Number of events 2 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Reproductive system and breast disorders Balanoposthitis	0.00% 0/209 • Baseline Up To 28 Weeks 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.	1.0% 1/98 • Number of events 1 • Baseline Up To 28 Weeks 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.
Reproductive system and breast disorders Prostatic calcification	0.00% 0/209 • Baseline Up To 28 Weeks 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.	1.0% 1/98 • Number of events 1 • Baseline Up To 28 Weeks 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.
Reproductive system and breast disorders Uterine atrophy	0.00% 0/150 • Baseline Up To 28 Weeks 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.	1.3% 1/79 • Number of events 1 • Baseline Up To 28 Weeks 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.
Respiratory, thoracic and mediastinal disorders Cough	3.6% 13/359 • Number of events 16 • Baseline Up To 28 Weeks 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.	2.8% 5/177 • Number of events 5 • Baseline Up To 28 Weeks 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.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.84% 3/359 • Number of events 4 • Baseline Up To 28 Weeks 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.	2.3% 4/177 • Number of events 4 • Baseline Up To 28 Weeks 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.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.56% 2/359 • Number of events 2 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Skin and subcutaneous tissue disorders Pruritus	1.1% 4/359 • Number of events 4 • Baseline Up To 28 Weeks 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.	0.00% 0/177 • Baseline Up To 28 Weeks 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.
Skin and subcutaneous tissue disorders Rash	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Vascular disorders Aortic arteriosclerosis	0.28% 1/359 • Number of events 1 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Vascular disorders Arteriosclerosis	0.84% 3/359 • Number of events 3 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 3 • Baseline Up To 28 Weeks 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.
Vascular disorders Diabetic vascular disorder	0.00% 0/359 • Baseline Up To 28 Weeks 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.	1.1% 2/177 • Number of events 2 • Baseline Up To 28 Weeks 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.
Vascular disorders Hypertension	5.6% 20/359 • Number of events 20 • Baseline Up To 28 Weeks 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.	4.0% 7/177 • Number of events 8 • Baseline Up To 28 Weeks 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.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: ClinicalTrials.gov@lilly.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60