Trial Outcomes & Findings for Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (NCT NCT02058160)
NCT ID: NCT02058160
Last Updated: 2017-05-09
Results Overview
Change in HbA1c was calculated by subtracting baseline value from Week 30 value.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
736 participants
Primary outcome timeframe
Baseline, Week 30
Results posted on
2017-05-09
Participant Flow
The study was conducted at 236 centers in 18 countries. A total of 1930 participants were screened between January 27, 2014 and October 15, 2014. 912 participants were not eligible for run-in-phase mainly due to glycated hemoglobin (HbA1c) value being out of the protocol defined range.
After screening phase, 1018 participants entered 6 week run-in phase during which participants were switched (if necessary) to insulin glargine and dose was titrated/stabilized, any oral anti-diabetic drugs (OAD) other than metformin were stopped. 282 participants were run-in failures and 736 were randomized in 1:1(FRC:insulin glargine arms) ratio.
Participant milestones
| Measure |
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)
FRC injected subcutaneously once daily (QD) for 30 weeks. Dose individually adjusted.
|
Insulin Glargine
Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
|---|---|---|
|
Overall Study
STARTED
|
367
|
369
|
|
Overall Study
Treated
|
365
|
365
|
|
Overall Study
COMPLETED
|
336
|
355
|
|
Overall Study
NOT COMPLETED
|
31
|
14
|
Reasons for withdrawal
| Measure |
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)
FRC injected subcutaneously once daily (QD) for 30 weeks. Dose individually adjusted.
|
Insulin Glargine
Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
|---|---|---|
|
Overall Study
Randomized but not treated
|
2
|
4
|
|
Overall Study
Poor compliance to protocol
|
4
|
1
|
|
Overall Study
Adverse Event
|
12
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Other than specified above
|
12
|
6
|
Baseline Characteristics
Only participants with available data for this baseline measure were included in the analysis.
Baseline characteristics by cohort
| Measure |
Insulin Glargine/Lixisenatide Fixed Ratio Combination
n=367 Participants
FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
Insulin Glargine
n=369 Participants
Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
Total
n=736 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 9.4 • n=367 Participants
|
60.3 years
STANDARD_DEVIATION 8.7 • n=369 Participants
|
60.0 years
STANDARD_DEVIATION 9.1 • n=736 Participants
|
|
Sex: Female, Male
Female
|
202 Participants
n=367 Participants
|
190 Participants
n=369 Participants
|
392 Participants
n=736 Participants
|
|
Sex: Female, Male
Male
|
165 Participants
n=367 Participants
|
179 Participants
n=369 Participants
|
344 Participants
n=736 Participants
|
|
Race
Caucasian
|
337 Participants
n=367 Participants
|
338 Participants
n=369 Participants
|
675 Participants
n=736 Participants
|
|
Race
Black
|
17 Participants
n=367 Participants
|
21 Participants
n=369 Participants
|
38 Participants
n=736 Participants
|
|
Race
Asian/Oriental
|
12 Participants
n=367 Participants
|
8 Participants
n=369 Participants
|
20 Participants
n=736 Participants
|
|
Race
Other
|
1 Participants
n=367 Participants
|
2 Participants
n=369 Participants
|
3 Participants
n=736 Participants
|
|
Ethnicity
Hispanic
|
66 Participants
n=367 Participants
|
66 Participants
n=369 Participants
|
132 Participants
n=736 Participants
|
|
Ethnicity
Not Hispanic
|
301 Participants
n=367 Participants
|
303 Participants
n=369 Participants
|
604 Participants
n=736 Participants
|
|
OAD Use
Yes
|
349 Participants
n=367 Participants
|
350 Participants
n=369 Participants
|
699 Participants
n=736 Participants
|
|
OAD Use
No
|
18 Participants
n=367 Participants
|
19 Participants
n=369 Participants
|
37 Participants
n=736 Participants
|
|
OAD Use at Screening by Class
Metformin
|
170 Participants
n=367 Participants
|
190 Participants
n=369 Participants
|
360 Participants
n=736 Participants
|
|
OAD Use at Screening by Class
Sulfonylurea
|
16 Participants
n=367 Participants
|
14 Participants
n=369 Participants
|
30 Participants
n=736 Participants
|
|
OAD Use at Screening by Class
Sodium glucose co-transporter 2 (SGLT-2) inhibitor
|
0 Participants
n=367 Participants
|
1 Participants
n=369 Participants
|
1 Participants
n=736 Participants
|
|
OAD Use at Screening by Class
Dipeptidyl-peptidase 4 (DPP-4) inhibitor
|
2 Participants
n=367 Participants
|
4 Participants
n=369 Participants
|
6 Participants
n=736 Participants
|
|
OAD Use at Screening by Class
Glinide
|
1 Participants
n=367 Participants
|
1 Participants
n=369 Participants
|
2 Participants
n=736 Participants
|
|
OAD Use at Screening by Class
Metformin + Sulfonylurea
|
137 Participants
n=367 Participants
|
118 Participants
n=369 Participants
|
255 Participants
n=736 Participants
|
|
OAD Use at Screening by Class
Metformin + DPP-4 inhibitor
|
20 Participants
n=367 Participants
|
18 Participants
n=369 Participants
|
38 Participants
n=736 Participants
|
|
OAD Use at Screening by Class
Metfomrin + Glinide
|
2 Participants
n=367 Participants
|
3 Participants
n=369 Participants
|
5 Participants
n=736 Participants
|
|
OAD Use at Screening by Class
Sulfonylurea + DPP-4 inhibitor
|
1 Participants
n=367 Participants
|
1 Participants
n=369 Participants
|
2 Participants
n=736 Participants
|
|
OAD Use at Screening by Class
None
|
18 Participants
n=367 Participants
|
19 Participants
n=369 Participants
|
37 Participants
n=736 Participants
|
|
Body Mass Index (BMI)
|
31.33 kg/m^2
STANDARD_DEVIATION 4.25 • n=367 Participants
|
30.96 kg/m^2
STANDARD_DEVIATION 4.15 • n=369 Participants
|
31.14 kg/m^2
STANDARD_DEVIATION 4.20 • n=736 Participants
|
|
Duration of Diabetes
|
12.02 years
STANDARD_DEVIATION 6.64 • n=367 Participants • Only participants with available data for this baseline measure were included in the analysis.
|
12.13 years
STANDARD_DEVIATION 6.85 • n=368 Participants • Only participants with available data for this baseline measure were included in the analysis.
|
12.08 years
STANDARD_DEVIATION 6.74 • n=735 Participants • Only participants with available data for this baseline measure were included in the analysis.
|
|
Daily Dose of Metformin
|
2082.8 mg
STANDARD_DEVIATION 499.2 • n=329 Participants • Only participants with available data for this baseline measure were included in the analysis.
|
2042.0 mg
STANDARD_DEVIATION 455.9 • n=329 Participants • Only participants with available data for this baseline measure were included in the analysis.
|
2062.4 mg
STANDARD_DEVIATION 478.1 • n=658 Participants • Only participants with available data for this baseline measure were included in the analysis.
|
|
Screening Glycated Hemoglobin (HbA1c)
|
8.51 percentage of HbA1c
STANDARD_DEVIATION 0.65 • n=367 Participants
|
8.54 percentage of HbA1c
STANDARD_DEVIATION 0.67 • n=369 Participants
|
8.53 percentage of HbA1c
STANDARD_DEVIATION 0.66 • n=736 Participants
|
|
Baseline HbA1c
|
8.07 percentage of HbA1c
STANDARD_DEVIATION 0.68 • n=367 Participants
|
8.08 percentage of HbA1c
STANDARD_DEVIATION 0.73 • n=369 Participants
|
8.08 percentage of HbA1c
STANDARD_DEVIATION 0.71 • n=736 Participants
|
|
Fasting Plasma Glucose (FPG)
|
7.34 mmol/L
STANDARD_DEVIATION 1.95 • n=367 Participants
|
7.36 mmol/L
STANDARD_DEVIATION 2.12 • n=369 Participants
|
7.35 mmol/L
STANDARD_DEVIATION 2.04 • n=736 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 30Population: Modified intent-to-treat (mITT) population: all randomized participants who had both baseline and at least one post-baseline efficacy assessment. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during study period.
Change in HbA1c was calculated by subtracting baseline value from Week 30 value.
Outcome measures
| Measure |
Insulin Glargine/Lixisenatide Fixed Ratio Combination
n=364 Participants
FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
Insulin Glargine
n=364 Participants
Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
|---|---|---|
|
Change in Glycated Hemoglobin (HbA1c) From Baseline to Week 30
|
-1.13 percentage of HbA1c
Standard Error 0.057
|
-0.62 percentage of HbA1c
Standard Error 0.055
|
SECONDARY outcome
Timeframe: Week 30Population: mITT population. Participants with no value for HbA1c at Week 30 were counted as non-responders.
Outcome measures
| Measure |
Insulin Glargine/Lixisenatide Fixed Ratio Combination
n=366 Participants
FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
Insulin Glargine
n=365 Participants
Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
|---|---|---|
|
Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30
HbA1c <7.0%
|
54.9 percentage of participants
|
29.6 percentage of participants
|
|
Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30
HbA1c ≤ 6.5%
|
33.9 percentage of participants
|
14.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 30Population: mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline plasma glucose excursion assessment during study period. Missing data was imputed using last observation carried forward (LOCF).
Plasma glucose excursion = 2-hour postprandial glucose (PPG) minus plasma glucose value obtained 30 minutes prior to the start of the meal and before investigational medicinal product (IMP) administration, if IMP was injected before breakfast. Change in plasma glucose excursions was calculated by subtracting baseline value from Week 30 value.
Outcome measures
| Measure |
Insulin Glargine/Lixisenatide Fixed Ratio Combination
n=329 Participants
FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
Insulin Glargine
n=336 Participants
Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
|---|---|---|
|
Change in 2-hour Plasma Blood Glucose Excursion From Baseline to Week 30
|
-3.9 mmol/L
Standard Error 0.285
|
-0.47 mmol/L
Standard Error 0.274
|
SECONDARY outcome
Timeframe: Baseline, Week 30Population: mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during study period.
Change in body weight was calculated by subtracting baseline value from Week 30 value.
Outcome measures
| Measure |
Insulin Glargine/Lixisenatide Fixed Ratio Combination
n=365 Participants
FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
Insulin Glargine
n=365 Participants
Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
|---|---|---|
|
Change in Body Weight From Baseline to Week 30
|
-0.67 kg
Standard Error 0.181
|
0.7 kg
Standard Error 0.178
|
SECONDARY outcome
Timeframe: Baseline, Week 30Population: mITT population. Here, number of participants analyzed= participants with baseline and at least one post-baseline 7-point SMPG assessment during study period.
Participants recorded a 7-point plasma glucose profile measured before and 2-hours after each meal and at bedtime, two times in a week before baseline, before visit Week 12 and before visit Week 30 and the average value across the profiles performed in the week before a visit for the 7 time points was calculated. Change in average 7 point SMPG was calculated by subtracting baseline value from Week 30 value. The analysis included all scheduled measurements obtained during the study. The missing data was handled by mixed effect model with repeated measures (MMRM) approach.
Outcome measures
| Measure |
Insulin Glargine/Lixisenatide Fixed Ratio Combination
n=323 Participants
FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
Insulin Glargine
n=320 Participants
Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
|---|---|---|
|
Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30
|
-1.5 mmol/L
Standard Error 0.137
|
-0.6 mmol/L
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Week 30Population: mITT population. Participants without HbA1c and/or body weight value at Week 30 were counted as non-responders.
Outcome measures
| Measure |
Insulin Glargine/Lixisenatide Fixed Ratio Combination
n=366 Participants
FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
Insulin Glargine
n=365 Participants
Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
|---|---|---|
|
Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30
|
34.2 percentage of participants
|
13.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 30Population: mITT population. The analysis included scheduled measurements obtained up to the date of last injection of IMP. Here, number of participants analyzed= participants with insulin glargine dose assessment during study period.
Outcome measures
| Measure |
Insulin Glargine/Lixisenatide Fixed Ratio Combination
n=364 Participants
FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
Insulin Glargine
n=365 Participants
Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
|---|---|---|
|
Change in Daily Insulin Glargine Dose From Baseline to Week 30
|
10.64 Units (U)
Standard Error 0.601
|
10.89 Units (U)
Standard Error 0.587
|
SECONDARY outcome
Timeframe: Baseline up to Week 30Population: mITT population. Participants without HbA1c and/or body weight value at Week 30 were counted as non-responders.
Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).
Outcome measures
| Measure |
Insulin Glargine/Lixisenatide Fixed Ratio Combination
n=366 Participants
FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
Insulin Glargine
n=365 Participants
Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
|---|---|---|
|
Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period
|
19.9 percentage of participants
|
9.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 30Population: mITT population. Here, number of participants analyzed= participants with baseline and at least one post-baseline FPG assessment during study period.
Change in FPG was calculated by subtracting baseline value from Week 30 value.
Outcome measures
| Measure |
Insulin Glargine/Lixisenatide Fixed Ratio Combination
n=364 Participants
FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
Insulin Glargine
n=364 Participants
Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
|---|---|---|
|
Change in FPG From Baseline to Week 30
|
-0.35 mmol/L
Standard Error 0.142
|
-0.46 mmol/L
Standard Error 0.138
|
SECONDARY outcome
Timeframe: Baseline, Week 30Population: mITT population. Here, number of participants analyzed= participants with baseline and at least one post-baseline PPG assessment during study period.
Change in PPG was calculated by subtracting baseline value from Week 30 value.
Outcome measures
| Measure |
Insulin Glargine/Lixisenatide Fixed Ratio Combination
n=332 Participants
FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
Insulin Glargine
n=340 Participants
Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
|---|---|---|
|
Change in 2-hour PPG From Baseline to Week 30
|
-4.72 mmol/L
Standard Error 0.322
|
-1.39 mmol/L
Standard Error 0.31
|
SECONDARY outcome
Timeframe: Baseline up to Week 30Population: mITT population. Participants with no value for HbA1c at Week 30 were counted as non-responders.
Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).
Outcome measures
| Measure |
Insulin Glargine/Lixisenatide Fixed Ratio Combination
n=366 Participants
FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
Insulin Glargine
n=365 Participants
Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
|---|---|---|
|
Percentage of Participants Reaching HbA1c <7.0% With No Documented Symptomatic Hypoglycemia (PG ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period
|
31.7 percentage of participants
|
18.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 30Population: mITT population.
Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values - from Week 8 to Week 12: fasting SMPG/FPG \>240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG \>200 mg/dL (11.1 mmol/L) or HbA1c \>8%.
Outcome measures
| Measure |
Insulin Glargine/Lixisenatide Fixed Ratio Combination
n=366 Participants
FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
Insulin Glargine
n=365 Participants
Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
|---|---|---|
|
Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period
|
2.7 percentage of participants
|
6 percentage of participants
|
SECONDARY outcome
Timeframe: First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])Population: Analysis was performed on safety population defined as all randomized participants who received at least one dose of IMP regardless of the amount of treatment administered.
Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).
Outcome measures
| Measure |
Insulin Glargine/Lixisenatide Fixed Ratio Combination
n=365 Participants
FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
Insulin Glargine
n=365 Participants
Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
|---|---|---|
|
Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year
|
3.03 events per subject-year
|
4.22 events per subject-year
|
SECONDARY outcome
Timeframe: First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])Population: Analysis was performed on safety population.
Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).
Outcome measures
| Measure |
Insulin Glargine/Lixisenatide Fixed Ratio Combination
n=365 Participants
FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
Insulin Glargine
n=365 Participants
Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
|---|---|---|
|
Percentage of Participants With Documented Symptomatic Hypoglycemia
|
40 percentage of participants
|
42.5 percentage of participants
|
SECONDARY outcome
Timeframe: First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])Population: Analysis was performed on safety population.
Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Plasma glucose measurements might not had been available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal was considered sufficient evidence that the event had been induced by a low plasma glucose concentration. Severe symptomatic hypoglycemia included all episodes in which neurological impairment was severe enough to prevent self-treatment, and which were thus thought to place participants at risk for injury to themselves or others.
Outcome measures
| Measure |
Insulin Glargine/Lixisenatide Fixed Ratio Combination
n=365 Participants
FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
Insulin Glargine
n=365 Participants
Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
|
|---|---|---|
|
Percentage of Participants With Severe Symptomatic Hypoglycemia
|
1.1 percentage of participants
|
0.3 percentage of participants
|
Adverse Events
Insulin Glargine/Lixisenatide Fixed Ratio Combination
Serious events: 20 serious events
Other events: 81 other events
Deaths: 0 deaths
Insulin Glargine
Serious events: 18 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Glargine/Lixisenatide Fixed Ratio Combination
n=365 participants at risk
FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 211 days).
|
Insulin Glargine
n=365 participants at risk
Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 210 days).
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Infections and infestations
Wound infection
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign gastric neoplasm
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.55%
2/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.55%
2/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Eye disorders
Glaucoma
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.55%
2/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Cardiac disorders
Angina unstable
|
0.55%
2/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Cardiac disorders
Myocardial infarction
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Vascular disorders
Hypertension
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
General disorders
Chest discomfort
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.55%
2/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Scar
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.27%
1/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
Other adverse events
| Measure |
Insulin Glargine/Lixisenatide Fixed Ratio Combination
n=365 participants at risk
FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 211 days).
|
Insulin Glargine
n=365 participants at risk
Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 210 days).
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
8.8%
32/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
8.8%
32/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Nervous system disorders
Headache
|
5.8%
21/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
2.7%
10/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Nausea
|
10.4%
38/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
0.55%
2/365 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent that is AEs that developed/worsened during 'on-emergent period' (time from first injection of open-label IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER