Trial Outcomes & Findings for Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus (NCT NCT02735044)
NCT ID: NCT02735044
Last Updated: 2022-03-25
Results Overview
Change in HbA1c was calculated by subtracting baseline value from Month 6 value. Adjusted least-square (LS) means and standard errors (SE) were obtained using analysis of covariance (ANCOVA) after multiple imputations of missing data using post-baseline HbA1c data available on the main 6-month randomized period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
463 participants
Primary outcome timeframe
Baseline to Month 6
Results posted on
2022-03-25
Participant Flow
The study was conducted at 105 centers in 24 countries. A total of 616 participants were screened between 14 April 2016 and 31 October 2017, of which 153 were screen failures. Screen failures were mainly due to glycated hemoglobin (HbA1c) level outside of defined ranges per eligibility criteria.
A total of 463 participants were randomized in the study. Randomization was stratified by age group (\<12 years and \>=12 years) and by HbA1c (\<8.5% and \>=8.5%). Assignment to arms was done centrally using interactive voice system in 1:1 ratio.
Participant milestones
| Measure |
HOE901-U300
Insulin glargine 300 Units/milliliter (U/mL) subcutaneous (SC) injection once daily in the morning or evening for 12 months.
|
Lantus
Insulin glargine 100 U/mL SC injection once daily in the morning or evening for 12 months.
|
|---|---|---|
|
Overall Study
STARTED
|
233
|
230
|
|
Overall Study
Treated
|
233
|
228
|
|
Overall Study
COMPLETED
|
217
|
207
|
|
Overall Study
NOT COMPLETED
|
16
|
23
|
Reasons for withdrawal
| Measure |
HOE901-U300
Insulin glargine 300 Units/milliliter (U/mL) subcutaneous (SC) injection once daily in the morning or evening for 12 months.
|
Lantus
Insulin glargine 100 U/mL SC injection once daily in the morning or evening for 12 months.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Poor compliance to protocol
|
7
|
7
|
|
Overall Study
Randomized and not treated
|
0
|
2
|
|
Overall Study
Other, not specified above
|
5
|
11
|
Baseline Characteristics
Here, number analyzed = participants with available data for specified measure.
Baseline characteristics by cohort
| Measure |
HOE901-U300
n=233 Participants
Insulin glargine 300 U/mL SC injection once daily in the morning or evening for 12 months.
|
Lantus
n=230 Participants
Insulin glargine 100 U/mL SC injection once daily in the morning or evening for 12 months.
|
Total
n=463 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.9 Years
STANDARD_DEVIATION 2.9 • n=233 Participants
|
12.9 Years
STANDARD_DEVIATION 2.9 • n=230 Participants
|
12.9 Years
STANDARD_DEVIATION 2.9 • n=463 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=233 Participants
|
121 Participants
n=230 Participants
|
226 Participants
n=463 Participants
|
|
Sex: Female, Male
Male
|
128 Participants
n=233 Participants
|
109 Participants
n=230 Participants
|
237 Participants
n=463 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=232 Participants • Here, number analyzed = participants with available data for specified measure.
|
0 Participants
n=226 Participants • Here, number analyzed = participants with available data for specified measure.
|
0 Participants
n=458 Participants • Here, number analyzed = participants with available data for specified measure.
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=232 Participants • Here, number analyzed = participants with available data for specified measure.
|
6 Participants
n=226 Participants • Here, number analyzed = participants with available data for specified measure.
|
17 Participants
n=458 Participants • Here, number analyzed = participants with available data for specified measure.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=232 Participants • Here, number analyzed = participants with available data for specified measure.
|
0 Participants
n=226 Participants • Here, number analyzed = participants with available data for specified measure.
|
0 Participants
n=458 Participants • Here, number analyzed = participants with available data for specified measure.
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=232 Participants • Here, number analyzed = participants with available data for specified measure.
|
6 Participants
n=226 Participants • Here, number analyzed = participants with available data for specified measure.
|
14 Participants
n=458 Participants • Here, number analyzed = participants with available data for specified measure.
|
|
Race (NIH/OMB)
White
|
211 Participants
n=232 Participants • Here, number analyzed = participants with available data for specified measure.
|
211 Participants
n=226 Participants • Here, number analyzed = participants with available data for specified measure.
|
422 Participants
n=458 Participants • Here, number analyzed = participants with available data for specified measure.
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=232 Participants • Here, number analyzed = participants with available data for specified measure.
|
2 Participants
n=226 Participants • Here, number analyzed = participants with available data for specified measure.
|
4 Participants
n=458 Participants • Here, number analyzed = participants with available data for specified measure.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=232 Participants • Here, number analyzed = participants with available data for specified measure.
|
1 Participants
n=226 Participants • Here, number analyzed = participants with available data for specified measure.
|
1 Participants
n=458 Participants • Here, number analyzed = participants with available data for specified measure.
|
|
Body Mass Index (BMI)
|
67.52 BMI percentile
STANDARD_DEVIATION 26.62 • n=233 Participants
|
69.13 BMI percentile
STANDARD_DEVIATION 26.64 • n=230 Participants
|
68.32 BMI percentile
STANDARD_DEVIATION 26.61 • n=463 Participants
|
|
Hemoglobin A1C (HbA1C)
|
8.65 percentage of A1C
STANDARD_DEVIATION 0.88 • n=233 Participants
|
8.61 percentage of A1C
STANDARD_DEVIATION 0.87 • n=230 Participants
|
8.63 percentage of A1C
STANDARD_DEVIATION 0.88 • n=463 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Analysis was performed on intent-to-treat (ITT) population that included all randomized participants, regardless of whether the treatment kit was used, and was analyzed according to the allocated treatment group. Here, 'Overall number of participants analyzed' signified number of participants with available data for the outcome measure.
Change in HbA1c was calculated by subtracting baseline value from Month 6 value. Adjusted least-square (LS) means and standard errors (SE) were obtained using analysis of covariance (ANCOVA) after multiple imputations of missing data using post-baseline HbA1c data available on the main 6-month randomized period.
Outcome measures
| Measure |
HOE901-U300
n=232 Participants
Insulin glargine 300 U/mL SC injection once daily in the morning or evening for 12 months.
|
Lantus
n=230 Participants
Insulin glargine 100 U/mL SC injection once daily in the morning or evening for 12 months.
|
|---|---|---|
|
Change From Baseline in HbA1c to Month 6
|
-0.399 Percentage of HbA1c
Standard Error 0.063
|
-0.402 Percentage of HbA1c
Standard Error 0.064
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Analysis was performed on ITT population. Here, 'Overall number of participants analyzed' signified number of participants with available data for the outcome measure.
Change in FPG was calculated by subtracting baseline value from Month 6 value. Adjusted LS means and SE were obtained using ANCOVA after multiple imputation to address missing data in the main 6 month randomized period.
Outcome measures
| Measure |
HOE901-U300
n=232 Participants
Insulin glargine 300 U/mL SC injection once daily in the morning or evening for 12 months.
|
Lantus
n=230 Participants
Insulin glargine 100 U/mL SC injection once daily in the morning or evening for 12 months.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) to Month 6
|
-0.563 millimole per liter (mmol/L)
Standard Error 0.372
|
-0.549 millimole per liter (mmol/L)
Standard Error 0.372
|
SECONDARY outcome
Timeframe: Month 6Population: Analysis was performed on ITT population.
Participants without any available HbA1c assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (\<8.5%; \>=8.5%) and randomization strata of age at screening (\<12 years, \>=12 years).
Outcome measures
| Measure |
HOE901-U300
n=233 Participants
Insulin glargine 300 U/mL SC injection once daily in the morning or evening for 12 months.
|
Lantus
n=230 Participants
Insulin glargine 100 U/mL SC injection once daily in the morning or evening for 12 months.
|
|---|---|---|
|
Percentage of Participants With HbA1c Values of <7.5% at Month 6
|
26.18 percentage of participants
|
23.48 percentage of participants
|
SECONDARY outcome
Timeframe: upto Month 6Population: Analysis was performed on ITT population.
Participants without any available HbA1c assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (\<8.5%; \>=8.5%) and randomization strata of age at screening (\<12 years, \>=12 years).
Outcome measures
| Measure |
HOE901-U300
n=233 Participants
Insulin glargine 300 U/mL SC injection once daily in the morning or evening for 12 months.
|
Lantus
n=230 Participants
Insulin glargine 100 U/mL SC injection once daily in the morning or evening for 12 months.
|
|---|---|---|
|
Percentage of Participants With HbA1c Values of <7.5% Without Any Episode of Severe and/or Documented Self-Monitored Plasma Glucose ([SMPG] <54 mg/dL [3.0 mmol/L]) Symptomatic Hypoglycemia During the Last 3 Months of the Main 6-month Randomized Period
|
4.29 percentage of participants
|
4.78 percentage of participants
|
SECONDARY outcome
Timeframe: Month 6Population: Analysis was performed on ITT population.
Participants without any available FPG assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (\<8.5%; \>=8.5%) and randomization strata of age at screening (\<12 years, \>=12 years).
Outcome measures
| Measure |
HOE901-U300
n=233 Participants
Insulin glargine 300 U/mL SC injection once daily in the morning or evening for 12 months.
|
Lantus
n=230 Participants
Insulin glargine 100 U/mL SC injection once daily in the morning or evening for 12 months.
|
|---|---|---|
|
Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) at Month 6
|
27.47 percentage of participants
|
26.52 percentage of participants
|
SECONDARY outcome
Timeframe: upto Month 6Population: Analysis was performed on ITT population.
Participants without any available HbA1c assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (\<8.5%; \>=8.5%) and randomization strata of age at screening (\<12 years, \>=12 years).
Outcome measures
| Measure |
HOE901-U300
n=233 Participants
Insulin glargine 300 U/mL SC injection once daily in the morning or evening for 12 months.
|
Lantus
n=230 Participants
Insulin glargine 100 U/mL SC injection once daily in the morning or evening for 12 months.
|
|---|---|---|
|
Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) Without Any Episode of Severe and/or Documented (SMPG <54 mg/dL [3.0 mmol/L]) Symptomatic Hypoglycemia During the Last 3 Months of the Main 6-month Randomized Period
|
9.44 percentage of participants
|
7.39 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Analysis was performed on ITT population. Here, 'Overall number of participants analyzed' signified number of participants with available data for the outcome measure.
8-point SMPG profiles were measured at the following 8 points: between 01:00 and 04:00 (clock time) at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Analysis was performed using a ANCOVA model including the fixed categorical effects of treatment group, randomization strata of screening HbA1c (\<8.5%; \>=8.5%), randomization strata of age at screening (\<12 years, \>=12 years) and the baseline 24-hour average 8-point profile SMPG.
Outcome measures
| Measure |
HOE901-U300
n=147 Participants
Insulin glargine 300 U/mL SC injection once daily in the morning or evening for 12 months.
|
Lantus
n=146 Participants
Insulin glargine 100 U/mL SC injection once daily in the morning or evening for 12 months.
|
|---|---|---|
|
Change From Baseline in 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles to Month 6
|
0.139 mmol/L
Standard Error 0.249
|
-0.266 mmol/L
Standard Error 0.250
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Analysis was performed on ITT population. Here, 'Overall number of participants analyzed' signified number of participants with available data for the outcome measure.
8-point SMPG profiles were measured at the following 8 points: between 01:00 and 04:00 (clock time) at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Variability was assessed by the coefficient of variation (standard deviation divided by mean) calculated over the 8-point SMPG. Analysis was performed using a ANCOVA model including the fixed categorical effects of treatment group, randomization strata of screening HbA1c (\<8.5%; \>=8.5%) and randomization strata of age at screening (\<12 years, \>=12 years).
Outcome measures
| Measure |
HOE901-U300
n=147 Participants
Insulin glargine 300 U/mL SC injection once daily in the morning or evening for 12 months.
|
Lantus
n=146 Participants
Insulin glargine 100 U/mL SC injection once daily in the morning or evening for 12 months.
|
|---|---|---|
|
Change From Baseline in Variability of 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles at Month 6
|
1.469 percentage of mean variability
Standard Error 1.409
|
0.789 percentage of mean variability
Standard Error 1.415
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Analysis was performed on ITT population. Here, 'number analyzed' = participants with available data for each specified category.
8-point SMPG profiles were measured for following 8 time points at Baseline and Month 6: between 01:00 and 04:00 (clock time) at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime.
Outcome measures
| Measure |
HOE901-U300
n=233 Participants
Insulin glargine 300 U/mL SC injection once daily in the morning or evening for 12 months.
|
Lantus
n=230 Participants
Insulin glargine 100 U/mL SC injection once daily in the morning or evening for 12 months.
|
|---|---|---|
|
Change From Baseline to Month 6 in 8-Point SMPG Profile Per Time Point
2 hours after breakfast
|
-0.26 mmol/L
Standard Deviation 7.18
|
-0.62 mmol/L
Standard Deviation 6.78
|
|
Change From Baseline to Month 6 in 8-Point SMPG Profile Per Time Point
Pre-lunch
|
0.43 mmol/L
Standard Deviation 6.99
|
1.11 mmol/L
Standard Deviation 6.85
|
|
Change From Baseline to Month 6 in 8-Point SMPG Profile Per Time Point
2 hours after lunch
|
0.49 mmol/L
Standard Deviation 7.64
|
-0.55 mmol/L
Standard Deviation 7.20
|
|
Change From Baseline to Month 6 in 8-Point SMPG Profile Per Time Point
Pre-dinner
|
0.29 mmol/L
Standard Deviation 8.05
|
-0.02 mmol/L
Standard Deviation 6.78
|
|
Change From Baseline to Month 6 in 8-Point SMPG Profile Per Time Point
2 hours after dinner
|
0.51 mmol/L
Standard Deviation 8.53
|
0.60 mmol/L
Standard Deviation 6.86
|
|
Change From Baseline to Month 6 in 8-Point SMPG Profile Per Time Point
Bedtime
|
0.86 mmol/L
Standard Deviation 7.60
|
-0.60 mmol/L
Standard Deviation 7.00
|
|
Change From Baseline to Month 6 in 8-Point SMPG Profile Per Time Point
Between 01:00 and 04:00 at night
|
0.84 mmol/L
Standard Deviation 6.94
|
-0.60 mmol/L
Standard Deviation 7.08
|
|
Change From Baseline to Month 6 in 8-Point SMPG Profile Per Time Point
Pre-breakfast
|
-0.41 mmol/L
Standard Deviation 5.48
|
-1.71 mmol/L
Standard Deviation 6.56
|
SECONDARY outcome
Timeframe: Month 12Population: Analysis was performed on the safety population which included all randomized participants who actually received who received at least 1 dose or part of a dose of IMP, and was analyzed according to treatment received.
Severe hypoglycemia: an event in which the child/adolescent having altered mental status and cannot assist in their care, is semiconscious or unconscious, or in coma ± convulsions and may require parenteral therapy (glucagon or glucose). Documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<=70 mg/dL (3.9 mmol/L). Asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration \<=70 mg/dL. Probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia were not accompanied by plasma glucose determination but was presumably caused by a plasma glucose concentration \<=70 mg/dL. Pseudo-hypoglycemia:an event with any of the typical symptoms of hypoglycaemia with plasma glucose concentration \>70 mg/dL.
Outcome measures
| Measure |
HOE901-U300
n=233 Participants
Insulin glargine 300 U/mL SC injection once daily in the morning or evening for 12 months.
|
Lantus
n=228 Participants
Insulin glargine 100 U/mL SC injection once daily in the morning or evening for 12 months.
|
|---|---|---|
|
Percentage of Participants With at Least One Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Symptomatic, Probable Symptomatic, Asymptomatic Hypoglycemia, Pseudo-hypoglycemia and Severe and/or Confirmed Hypoglycemia) at Month 12
Probable Symptomatic Hypoglycemia
|
10.3 percentage of participants
|
13.6 percentage of participants
|
|
Percentage of Participants With at Least One Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Symptomatic, Probable Symptomatic, Asymptomatic Hypoglycemia, Pseudo-hypoglycemia and Severe and/or Confirmed Hypoglycemia) at Month 12
Asymptomatic Hypoglycemia
|
88.4 percentage of participants
|
89.5 percentage of participants
|
|
Percentage of Participants With at Least One Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Symptomatic, Probable Symptomatic, Asymptomatic Hypoglycemia, Pseudo-hypoglycemia and Severe and/or Confirmed Hypoglycemia) at Month 12
Pseudo-hypoglycemia
|
15.9 percentage of participants
|
14.5 percentage of participants
|
|
Percentage of Participants With at Least One Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Symptomatic, Probable Symptomatic, Asymptomatic Hypoglycemia, Pseudo-hypoglycemia and Severe and/or Confirmed Hypoglycemia) at Month 12
Any hypoglycemia
|
99.1 percentage of participants
|
98.7 percentage of participants
|
|
Percentage of Participants With at Least One Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Symptomatic, Probable Symptomatic, Asymptomatic Hypoglycemia, Pseudo-hypoglycemia and Severe and/or Confirmed Hypoglycemia) at Month 12
Severe Hypoglycemia
|
8.6 percentage of participants
|
11.0 percentage of participants
|
|
Percentage of Participants With at Least One Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Symptomatic, Probable Symptomatic, Asymptomatic Hypoglycemia, Pseudo-hypoglycemia and Severe and/or Confirmed Hypoglycemia) at Month 12
Documented Symptomatic Hypoglycemia
|
94.8 percentage of participants
|
93.9 percentage of participants
|
|
Percentage of Participants With at Least One Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Symptomatic, Probable Symptomatic, Asymptomatic Hypoglycemia, Pseudo-hypoglycemia and Severe and/or Confirmed Hypoglycemia) at Month 12
Severe and/or documented hypoglycemia
|
99.1 percentage of participants
|
98.2 percentage of participants
|
SECONDARY outcome
Timeframe: Month 12Population: Analysis was performed on the safety population.
Hyperglycemia with ketosis was defined as SMPG \>=252 mg/dL (14 mmol/L) with accompanying self-measured blood ketones \>=1.5 mmol/L.
Outcome measures
| Measure |
HOE901-U300
n=233 Participants
Insulin glargine 300 U/mL SC injection once daily in the morning or evening for 12 months.
|
Lantus
n=228 Participants
Insulin glargine 100 U/mL SC injection once daily in the morning or evening for 12 months.
|
|---|---|---|
|
Percentage of Participants With Any Hyperglycemia With Ketosis at Month 12
|
9.9 percentage of participants
|
13.6 percentage of participants
|
Adverse Events
HOE901-U300
Serious events: 35 serious events
Other events: 105 other events
Deaths: 1 deaths
Lantus
Serious events: 31 serious events
Other events: 118 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HOE901-U300
n=233 participants at risk
Insulin glargine 300 U/mL SC injection once daily in the morning or evening for 12 months.
|
Lantus
n=228 participants at risk
Insulin glargine 100 U/mL SC injection once daily in the morning or evening for 12 months.
|
|---|---|---|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/233 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.44%
1/228 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Infections and infestations
Appendicitis
|
0.43%
1/233 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.88%
2/228 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Infections and infestations
Gastroenteritis
|
0.43%
1/233 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.44%
1/228 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.43%
1/233 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/228 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Infections and infestations
Meningococcal Infection
|
0.00%
0/233 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.44%
1/228 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/233 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.44%
1/228 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/233 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.44%
1/228 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Infections and infestations
Urinary Tract Infection
|
0.43%
1/233 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.44%
1/228 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Infections and infestations
Vulvitis
|
0.00%
0/233 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.44%
1/228 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.43%
1/233 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.44%
1/228 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Electric Shock
|
0.00%
0/233 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.44%
1/228 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Fall
|
0.43%
1/233 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/228 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.43%
1/233 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/228 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.43%
1/233 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/228 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.43%
1/233 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/228 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Investigations
Alanine Aminotransferase Increased
|
1.3%
3/233 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.44%
1/228 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.86%
2/233 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.88%
2/228 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
2.1%
5/233 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
2.6%
6/228 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Diabetic Metabolic Decompensation
|
0.43%
1/233 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/228 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.43%
1/233 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/228 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.86%
2/233 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/228 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Ketosis
|
0.43%
1/233 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/228 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Nervous system disorders
Autonomic Nervous System Imbalance
|
0.43%
1/233 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/228 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/233 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.44%
1/228 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Nervous system disorders
Hypoglycaemic Coma
|
0.43%
1/233 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/228 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Nervous system disorders
Hypoglycaemic Seizure
|
3.4%
8/233 • Number of events 11 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
4.4%
10/228 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Nervous system disorders
Hypoglycaemic Unconsciousness
|
2.6%
6/233 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
4.4%
10/228 • Number of events 11 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Nervous system disorders
Seizure
|
0.43%
1/233 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/228 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Nervous system disorders
Syncope
|
0.43%
1/233 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/228 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Pregnancy, puerperium and perinatal conditions
Anembryonic Gestation
|
0.43%
1/233 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/228 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Psychiatric disorders
Completed Suicide
|
0.43%
1/233 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/228 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/233 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.44%
1/228 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Testicular Torsion
|
0.00%
0/233 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.44%
1/228 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Dermal Cyst
|
0.43%
1/233 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
0.00%
0/228 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
Other adverse events
| Measure |
HOE901-U300
n=233 participants at risk
Insulin glargine 300 U/mL SC injection once daily in the morning or evening for 12 months.
|
Lantus
n=228 participants at risk
Insulin glargine 100 U/mL SC injection once daily in the morning or evening for 12 months.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
6.0%
14/233 • Number of events 20 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
3.9%
9/228 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Infections and infestations
Gastroenteritis
|
5.2%
12/233 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
4.4%
10/228 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Infections and infestations
Influenza
|
6.0%
14/233 • Number of events 17 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
8.3%
19/228 • Number of events 25 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Infections and infestations
Nasopharyngitis
|
15.9%
37/233 • Number of events 57 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
17.1%
39/228 • Number of events 60 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Infections and infestations
Pharyngitis
|
6.0%
14/233 • Number of events 18 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
9.6%
22/228 • Number of events 29 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.6%
20/233 • Number of events 28 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
7.9%
18/228 • Number of events 21 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Ketosis
|
8.2%
19/233 • Number of events 50 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
13.2%
30/228 • Number of events 52 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Overweight
|
0.86%
2/233 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
5.7%
13/228 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Nervous system disorders
Headache
|
8.2%
19/233 • Number of events 38 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
6.6%
15/228 • Number of events 23 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
6.4%
15/233 • Number of events 17 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
3.1%
7/228 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first dose of IMP up to 2 days after last injection of IMP). Analysis was performed on safety population.
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Phone: 800-633-1610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER