Trial Outcomes & Findings for A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus (NCT NCT02501161)
NCT ID: NCT02501161
Last Updated: 2019-11-27
Results Overview
Inadequate glycaemic control and need for treatment intensification was defined as a glycosylated haemoglobin (HbA1c) of 7.0% or greater at 2 consecutive visits from week 26, including week 26 if HbA1c was greater than or equal to 7% at week 12. Time from randomisation to inadequate glycaemic control and need for treatment intensification was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable "baseline HbA1c group" was a dichotomised baseline HbA1c variable with 2 categories: HbA1c \< 8.5% or HbA1c ≥ 8.5% and the variable "previous OAD treatment" was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1012 participants
Primary outcome timeframe
Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2
Results posted on
2019-11-27
Participant Flow
The trial was conducted at 130 sites in Argentina (4),Czech Republic (4), Hungary (5), India (11), Israel (8), Italy (7), Mexico (4), Norway (7), Poland (3), Russian Federation (8), Slovakia (5), South Africa (10), Turkey (8), United Kingdom (9) and United States (37).
Participants were randomised in a 1:1 manner to receive either IDegLira or IGlar as an adjunct to oral anti-diabetic drugs (OADs). OADs allowed were: biguanides, sulphonylurea (SU), glinides, pioglitazone, and dipeptidyl peptidase-4 inhibitors (DPP4-inhibitors), though glinides and DPP4-inhibitors were not allowed as monotherapy or in combination.
Participant milestones
| Measure |
Insulin Degludec/Liraglutide
Participants received subcutaneous (s.c.) injection of Insulin degludec/liraglutide (IDegLira) once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 milligrams \[mg\] liraglutide) initially. The dose was then escalated twice weekly until the fasting plasma glucose (FPG) target between 4.0-5.0 millimoles per liter (mmol/L) (72-90 milligrams per deciliter \[mg/dL\]) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Overall Study
STARTED
|
506
|
506
|
|
Overall Study
Exposed
|
506
|
504
|
|
Overall Study
COMPLETED
|
484
|
481
|
|
Overall Study
NOT COMPLETED
|
22
|
25
|
Reasons for withdrawal
| Measure |
Insulin Degludec/Liraglutide
Participants received subcutaneous (s.c.) injection of Insulin degludec/liraglutide (IDegLira) once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 milligrams \[mg\] liraglutide) initially. The dose was then escalated twice weekly until the fasting plasma glucose (FPG) target between 4.0-5.0 millimoles per liter (mmol/L) (72-90 milligrams per deciliter \[mg/dL\]) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
6
|
|
Overall Study
Lost to Follow-up
|
7
|
4
|
|
Overall Study
Withdrawal by Subject
|
10
|
15
|
|
Overall Study
Other
|
3
|
0
|
Baseline Characteristics
A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
Total
n=1012 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.8 Years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
56.4 Years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
56.6 Years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
226 Participants
n=5 Participants
|
231 Participants
n=7 Participants
|
457 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
280 Participants
n=5 Participants
|
275 Participants
n=7 Participants
|
555 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
115 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
241 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
391 Participants
n=5 Participants
|
380 Participants
n=7 Participants
|
771 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
424 Participants
n=5 Participants
|
414 Participants
n=7 Participants
|
838 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
54 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2Population: FAS included all randomised participants. Number analyzed=participants in the specified category.
Inadequate glycaemic control and need for treatment intensification was defined as a glycosylated haemoglobin (HbA1c) of 7.0% or greater at 2 consecutive visits from week 26, including week 26 if HbA1c was greater than or equal to 7% at week 12. Time from randomisation to inadequate glycaemic control and need for treatment intensification was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable "baseline HbA1c group" was a dichotomised baseline HbA1c variable with 2 categories: HbA1c \< 8.5% or HbA1c ≥ 8.5% and the variable "previous OAD treatment" was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification
Baseline HbA1c <8.5% + Non-SU users
|
NA Weeks
Interval 104.0 to
The estimated median and 75 percentile data were not available as the proportions were not reached within study period.
|
104.3 Weeks
Interval 38.1 to
The 75 percentile data was not available as the proportions was not reached within study period.
|
|
Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification
Baseline HbA1c <8.5% + SU users
|
106.7 Weeks
Interval 89.9 to
The 75 percentile data was not available as the proportions was not reached within study period.
|
90.3 Weeks
Interval 26.4 to 105.1
|
|
Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification
Baseline HbA1c >=8.5% + Non-SU users
|
NA Weeks
Interval 39.7 to
The estimated median and 75 percentile data were not available as the proportions were not reached within study period.
|
64.6 Weeks
Interval 26.1 to 105.1
|
|
Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification
Baseline HbA1c >=8.5% + SU users
|
104.0 Weeks
Interval 26.4 to
The 75 percentile data was not available as the proportions was not reached within study period.
|
26.6 Weeks
Interval 26.1 to 91.1
|
SECONDARY outcome
Timeframe: Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2Population: FAS included all randomised participants. Number analyzed=participants with event.
Time to HbA1c \> 6.5% at 2 consecutive visits is defined as time from randomization to HbA1c \> 6.5% at 2 consecutive planned scheduled visits from week 26 (including week 26 if HbA1c was \> 6.5% at week 12). Time from randomisation to HbA1c \>6.5% at 2 consecutive visits was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable "baseline HbA1c group" was a dichotomised baseline HbA1c variable with 2 categories: HbA1c \< 8.5% or HbA1c ≥ 8.5% and the variable "previous OAD treatment" was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits
Baseline HbA1c <8.5% + Non-SU users
|
NA Weeks
Interval 52.1 to
The estimated median and 75 percentile data were not available as the proportions were not reached within study period.
|
64.1 Weeks
Interval 26.1 to 104.3
|
|
Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits
Baseline HbA1c <8.5% + SU users
|
90.1 Weeks
Interval 27.0 to
The 75 percentile data was not available as the proportion was not reached within study period.
|
26.6 Weeks
Interval 26.1 to 89.9
|
|
Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits
Baseline HbA1c >=8.5% + Non-SU users
|
64.1 Weeks
Interval 26.1 to
The 75 percentile data was not available as the proportion was not reached within study period.
|
26.6 Weeks
Interval 26.1 to 90.1
|
|
Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits
Baseline HbA1c >=8.5% + SU users
|
52.1 Weeks
Interval 26.1 to 104.1
|
26.1 Weeks
Interval 26.1 to 38.1
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Change in HbA1c from baseline (week 0) to week 26 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in HbA1c
|
-1.99 Percentage of HbA1c
Standard Deviation 1.14
|
-1.69 Percentage of HbA1c
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Change in body weight from baseline (week 0) to week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Body Weight
Week 26
|
0.5 Kilogram (kg)
Standard Deviation 3.3
|
2.2 Kilogram (kg)
Standard Deviation 3.6
|
|
Change in Body Weight
Week 104
|
1.2 Kilogram (kg)
Standard Deviation 4.9
|
3.0 Kilogram (kg)
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Week 26, week 104Population: Safety analysis set (SAS) included all participants receiving at least 1 dose of the investigational product (IDegLira) or comparator (IGlar). 'Number analyzed'=participants with available data.
Insulin dose after 26 and 104 weeks of treatment is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Insulin Dose
Week 26
|
34.6 Units
Standard Deviation 13.4
|
48.6 Units
Standard Deviation 28.2
|
|
Insulin Dose
Week 104
|
36.1 Units
Standard Deviation 12.9
|
50.6 Units
Standard Deviation 31.5
|
SECONDARY outcome
Timeframe: Week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Percentage of participants who achieved (yes/no) HbA1c \<7.0% at week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Participants Who Achieved (Yes/no): HbA1c <7.0%
Week 26: Yes
|
78.7 Percentage of participants
|
55.7 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c <7.0%
Week 26: No
|
21.3 Percentage of participants
|
44.3 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c <7.0%
Week 104: Yes
|
55.5 Percentage of participants
|
28.5 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c <7.0%
Week 104: No
|
44.5 Percentage of participants
|
71.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Percentage of participants who achieved (yes/no) HbA1c \<7.0% without weight gain at week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain
Week 26: Yes
|
38.5 Percentage of participants
|
15.4 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain
Week 26: No
|
61.5 Percentage of participants
|
84.6 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain
Week 104: Yes
|
20.9 Percentage of participants
|
6.3 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain
Week 104: No
|
79.1 Percentage of participants
|
93.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c \<7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Week 26: Yes
|
71.3 Percentage of participants
|
44.9 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Week 26: No
|
28.7 Percentage of participants
|
55.1 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Week 104: Yes
|
51.8 Percentage of participants
|
25.5 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Week 104: No
|
48.2 Percentage of participants
|
74.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c \<7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain
Week 26: Yes
|
35.2 Percentage of participants
|
13.6 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain
Week 26: No
|
64.8 Percentage of participants
|
86.4 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain
Week 104: Yes
|
20.0 Percentage of participants
|
6.1 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain
Week 104: No
|
80.0 Percentage of participants
|
93.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Percentage of participants who achieved (yes/no) HbA1c ≤6.5% at week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Participants Who Achieved (Yes/no): HbA1c ≤6.5%
Week 26: Yes
|
63.6 Percentage of participants
|
35.4 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c ≤6.5%
Week 26: No
|
36.4 Percentage of participants
|
64.6 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c ≤6.5%
Week 104: Yes
|
43.3 Percentage of participants
|
21.7 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c ≤6.5%
Week 104: No
|
56.7 Percentage of participants
|
78.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without weight gain at week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain
Week 104: Yes
|
17.6 Percentage of participants
|
5.7 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain
Week 26: Yes
|
33.2 Percentage of participants
|
9.9 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain
Week 26: No
|
66.8 Percentage of participants
|
90.1 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain
Week 104: No
|
82.4 Percentage of participants
|
94.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Week 26: Yes
|
57.9 Percentage of participants
|
27.9 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Week 26: No
|
42.1 Percentage of participants
|
72.1 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Week 104: Yes
|
40.1 Percentage of participants
|
19.2 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Week 104: No
|
59.9 Percentage of participants
|
80.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain
Week 26: Yes
|
30.2 Percentage of participants
|
8.7 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain
Week 26: No
|
69.8 Percentage of participants
|
91.3 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain
Week 104: Yes
|
16.6 Percentage of participants
|
5.5 Percentage of participants
|
|
Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain
Week 104: No
|
83.4 Percentage of participants
|
94.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Change in fasting plasma glucose (FPG) from baseline (week 0) to week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in FPG
Week 26
|
-3.97 mmol/L
Standard Deviation 3.06
|
-3.79 mmol/L
Standard Deviation 3.18
|
|
Change in FPG
Week 104
|
-3.93 mmol/L
Standard Deviation 2.96
|
-3.73 mmol/L
Standard Deviation 2.75
|
SECONDARY outcome
Timeframe: Week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Self-measured plasma glucose (SMPG)-9-point profile (individual points in the profile) at week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
SMPG-9-point Profile (Individual Points in the Profile)
Week 26: Before breakfast
|
5.59 mmol/L
Standard Deviation 1.57
|
5.58 mmol/L
Standard Deviation 1.58
|
|
SMPG-9-point Profile (Individual Points in the Profile)
Week 26: 90 minutes after breakfast
|
8.34 mmol/L
Standard Deviation 2.62
|
8.76 mmol/L
Standard Deviation 2.68
|
|
SMPG-9-point Profile (Individual Points in the Profile)
Week 26: Before lunch
|
6.03 mmol/L
Standard Deviation 2.00
|
6.43 mmol/L
Standard Deviation 2.24
|
|
SMPG-9-point Profile (Individual Points in the Profile)
Week 26: 90 minutes after lunch
|
8.02 mmol/L
Standard Deviation 2.32
|
8.79 mmol/L
Standard Deviation 2.64
|
|
SMPG-9-point Profile (Individual Points in the Profile)
Week 26: Before dinner
|
6.67 mmol/L
Standard Deviation 2.26
|
6.91 mmol/L
Standard Deviation 2.35
|
|
SMPG-9-point Profile (Individual Points in the Profile)
Week 26: 90 minutes after dinner
|
8.31 mmol/L
Standard Deviation 2.47
|
9.10 mmol/L
Standard Deviation 2.70
|
|
SMPG-9-point Profile (Individual Points in the Profile)
Week 26: Bedtime
|
7.48 mmol/L
Standard Deviation 2.42
|
8.13 mmol/L
Standard Deviation 2.68
|
|
SMPG-9-point Profile (Individual Points in the Profile)
Week 26: At 4:00 a.m.
|
5.72 mmol/L
Standard Deviation 1.55
|
5.91 mmol/L
Standard Deviation 1.99
|
|
SMPG-9-point Profile (Individual Points in the Profile)
Week 26: Before breakfast the following day
|
5.53 mmol/L
Standard Deviation 1.37
|
5.56 mmol/L
Standard Deviation 1.56
|
|
SMPG-9-point Profile (Individual Points in the Profile)
Week 104: Before breakfast
|
5.58 mmol/L
Standard Deviation 1.38
|
5.57 mmol/L
Standard Deviation 1.27
|
|
SMPG-9-point Profile (Individual Points in the Profile)
Week 104: 90 minutes after breakfast
|
7.99 mmol/L
Standard Deviation 2.50
|
8.64 mmol/L
Standard Deviation 2.59
|
|
SMPG-9-point Profile (Individual Points in the Profile)
Week 104: Before lunch
|
6.06 mmol/L
Standard Deviation 1.91
|
6.37 mmol/L
Standard Deviation 2.02
|
|
SMPG-9-point Profile (Individual Points in the Profile)
Week 104: 90 minutes after lunch
|
7.80 mmol/L
Standard Deviation 2.16
|
8.87 mmol/L
Standard Deviation 2.45
|
|
SMPG-9-point Profile (Individual Points in the Profile)
Week 104: Before dinner
|
6.58 mmol/L
Standard Deviation 1.97
|
7.02 mmol/L
Standard Deviation 2.45
|
|
SMPG-9-point Profile (Individual Points in the Profile)
Week 104: 90 minutes after dinner
|
8.20 mmol/L
Standard Deviation 2.20
|
9.10 mmol/L
Standard Deviation 2.61
|
|
SMPG-9-point Profile (Individual Points in the Profile)
Week 104: Bedtime
|
7.47 mmol/L
Standard Deviation 2.17
|
7.90 mmol/L
Standard Deviation 2.41
|
|
SMPG-9-point Profile (Individual Points in the Profile)
Week 104: At 4:00 a.m.
|
5.67 mmol/L
Standard Deviation 1.35
|
5.96 mmol/L
Standard Deviation 1.73
|
|
SMPG-9-point Profile (Individual Points in the Profile)
Week 104: Before breakfast the following day
|
5.44 mmol/L
Standard Deviation 1.23
|
5.47 mmol/L
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean 9-point profile from baseline (week 0) to week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in SMPG-mean 9-point Profile
Week 26
|
-3.34 mmol/L
Standard Deviation 2.46
|
-3.32 mmol/L
Standard Deviation 2.62
|
|
Change in SMPG-mean 9-point Profile
Week 104
|
-3.27 mmol/L
Standard Deviation 2.36
|
-2.76 mmol/L
Standard Deviation 2.41
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean postprandial increment over all meals from baseline (week 0) to week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in SMPG-mean Postprandial Increment Over All Meals
Week 26
|
-0.28 mmol/L
Standard Deviation 2.13
|
0.20 mmol/L
Standard Deviation 2.17
|
|
Change in SMPG-mean Postprandial Increment Over All Meals
Week 104
|
-0.47 mmol/L
Standard Deviation 1.99
|
0.12 mmol/L
Standard Deviation 2.17
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Change in blood pressure (systolic and diastolic) from baseline (week 0) to week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Blood Pressure (Systolic and Diastolic)
Week 26: Systolic blood pressure
|
-1.2 Millimeters of mercury (mmHg)
Standard Deviation 14.0
|
0.5 Millimeters of mercury (mmHg)
Standard Deviation 13.1
|
|
Change in Blood Pressure (Systolic and Diastolic)
Week 26: Diastolic blood pressure
|
0.1 Millimeters of mercury (mmHg)
Standard Deviation 8.8
|
-0.3 Millimeters of mercury (mmHg)
Standard Deviation 8.4
|
|
Change in Blood Pressure (Systolic and Diastolic)
Week 104: Systolic blood pressure
|
0.5 Millimeters of mercury (mmHg)
Standard Deviation 14.3
|
0.9 Millimeters of mercury (mmHg)
Standard Deviation 13.6
|
|
Change in Blood Pressure (Systolic and Diastolic)
Week 104: Diastolic blood pressure
|
-0.1 Millimeters of mercury (mmHg)
Standard Deviation 8.8
|
-0.2 Millimeters of mercury (mmHg)
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Change in fasting C-peptide (measured in nanomoles per liter \[nmol/L\]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Fasting C-peptide
Week 26
|
0.63 Ratio of C-peptide
Geometric Coefficient of Variation 60.79
|
0.57 Ratio of C-peptide
Geometric Coefficient of Variation 62.44
|
|
Change in Fasting C-peptide
Week 104
|
0.58 Ratio of C-peptide
Geometric Coefficient of Variation 64.21
|
0.54 Ratio of C-peptide
Geometric Coefficient of Variation 70.45
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Change in fasting human insulin (measured in picomoles per liter \[pmol/L\]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Fasting Human Insulin
Week 26
|
0.67 Ratio of insulin
Geometric Coefficient of Variation 90.68
|
0.68 Ratio of insulin
Geometric Coefficient of Variation 89.19
|
|
Change in Fasting Human Insulin
Week 104
|
0.60 Ratio of insulin
Geometric Coefficient of Variation 91.84
|
0.62 Ratio of insulin
Geometric Coefficient of Variation 92.55
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Fasting Total Cholesterol
Week 26
|
0.99 Ratio of total cholesterol
Geometric Coefficient of Variation 17.38
|
0.99 Ratio of total cholesterol
Geometric Coefficient of Variation 17.68
|
|
Change in Fasting Total Cholesterol
Week 104
|
0.97 Ratio of total cholesterol
Geometric Coefficient of Variation 19.11
|
0.97 Ratio of total cholesterol
Geometric Coefficient of Variation 20.40
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Change in fasting low density lipoprotein (LDL)-cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Fasting LDL-cholesterol
Week 26
|
1.05 Ratio of LDL-cholesterol
Geometric Coefficient of Variation 35.97
|
1.02 Ratio of LDL-cholesterol
Geometric Coefficient of Variation 30.10
|
|
Change in Fasting LDL-cholesterol
Week 104
|
0.96 Ratio of LDL-cholesterol
Geometric Coefficient of Variation 38.83
|
0.98 Ratio of LDL-cholesterol
Geometric Coefficient of Variation 34.40
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Change in fasting high density lipoprotein (HDL)- cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Fasting HDL-cholesterol
Week 26
|
1.03 Ratio of HDL-cholesterol
Geometric Coefficient of Variation 16.61
|
1.02 Ratio of HDL-cholesterol
Geometric Coefficient of Variation 15.57
|
|
Change in Fasting HDL-cholesterol
Week 104
|
1.02 Ratio of HDL-cholesterol
Geometric Coefficient of Variation 16.93
|
1.03 Ratio of HDL-cholesterol
Geometric Coefficient of Variation 17.36
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Change in fasting very low density lipoprotein (VLDL)-cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Fasting VLDL-cholesterol
Week 26
|
0.85 Ratio of VLDL-cholesterol
Geometric Coefficient of Variation 40.78
|
0.85 Ratio of VLDL-cholesterol
Geometric Coefficient of Variation 42.01
|
|
Change in Fasting VLDL-cholesterol
Week 104
|
0.90 Ratio of VLDL-cholesterol
Geometric Coefficient of Variation 40.90
|
0.88 Ratio of VLDL-cholesterol
Geometric Coefficient of Variation 35.98
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Change in fasting triglycerides (measured as mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Fasting Triglycerides
Week 26
|
0.84 Ratio of triglycerides
Geometric Coefficient of Variation 43.82
|
0.85 Ratio of triglycerides
Geometric Coefficient of Variation 45.75
|
|
Change in Fasting Triglycerides
Week 104
|
0.89 Ratio of triglycerides
Geometric Coefficient of Variation 42.20
|
0.89 Ratio of triglycerides
Geometric Coefficient of Variation 40.08
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Change in fasting free fatty acids (measured as mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Fasting Free Fatty Acids
Week 26
|
0.68 Ratio of free fatty acids
Geometric Coefficient of Variation 59.69
|
0.75 Ratio of free fatty acids
Geometric Coefficient of Variation 60.25
|
|
Change in Fasting Free Fatty Acids
Week 104
|
0.70 Ratio of free fatty acids
Geometric Coefficient of Variation 57.71
|
0.78 Ratio of free fatty acids
Geometric Coefficient of Variation 59.48
|
SECONDARY outcome
Timeframe: Weeks 0-26Population: SAS included all participants receiving at least 1 dose of the investigational product or comparator.
Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during 26 weeks of treatment is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment
|
143 Episodes
|
261 Episodes
|
SECONDARY outcome
Timeframe: Weeks 0-104Population: SAS included all participants receiving at least 1 dose of the investigational product or comparator.
Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during 104 weeks of treatment is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment
|
319 Episodes
|
642 Episodes
|
SECONDARY outcome
Timeframe: Weeks 0-26Population: SAS included all participants receiving at least 1 dose of the investigational product or comparator.
Hypoglycaemic episodes (SMPG value ≤3.9 mmol/L (70 mg/dL)) were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent hypoglycaemic episodes according to ADA during 26 weeks of treatment is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Number of Treatment Emergent Hypoglycaemic Episodes During 26 Weeks of Treatment
|
3190 Episodes
|
3806 Episodes
|
SECONDARY outcome
Timeframe: Weeks 0-104Population: SAS included all participants receiving at least 1 dose of the investigational product or comparator.
Hypoglycaemic episodes (SMPG value ≤3.9 mmol/L (70 mg/dL)) were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment emergent hypoglycaemic episodes according to ADA during 104 weeks of treatment is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Number of Treatment Emergent Hypoglycaemic Episodes During 104 Weeks of Treatment
|
8934 Episodes
|
10658 Episodes
|
SECONDARY outcome
Timeframe: Weeks 0-26Population: SAS included all participants receiving at least 1 dose of the investigational product or comparator.
Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 both inclusive. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes during 26 weeks of treatment is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment
|
27 Episodes
|
60 Episodes
|
SECONDARY outcome
Timeframe: Weeks 0-104Population: SAS included all participants receiving at least 1 dose of the investigational product or comparator.
Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 both inclusive. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes during 104 weeks of treatment is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment
|
61 Episodes
|
164 Episodes
|
SECONDARY outcome
Timeframe: Weeks 0-26Population: SAS included all participants receiving at least 1 dose of the investigational product or comparator.
An adverse event is any untoward medical occurrence in a participant administered a product, and which does not necessarily have a causal relationship with this treatment. A treatment emergent adverse event (TEAE) was defined as an adverse event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product. If the event had onset date before the first day of exposure on trial product and increased in severity during the treatment period and until 7 days after the last drug date, then this event was also considered as a TEAE. Number of TEAEs during 26 weeks of treatment is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Number of TEAEs During 26 Weeks of Treatment
|
718 Adverse events
|
624 Adverse events
|
SECONDARY outcome
Timeframe: Week 0 to week 104Population: SAS included all participants receiving at least 1 dose of the investigational product or comparator.
An adverse event is any untoward medical occurrence in a participant administered a product, and which does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product. If the event had onset date before the first day of exposure on trial product and increased in severity during the treatment period and until 7 days after the last drug date, then this event was also considered as a TEAE. Number of TEAEs during 104 weeks of treatment is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Number of TEAEs During 104 Weeks of Treatment
|
1788 Adverse events
|
1368 Adverse events
|
SECONDARY outcome
Timeframe: Baseline (within 12 weeks prior to week 0), week 104Population: SAS included all participants receiving at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
Fundus photography or a dilated fundoscopy was performed at baseline (within 12 weeks prior to week 0) and week 104. The investigator interpreted each eye's (left and right) results and categorised them as: normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Number of participants in each category at baseline and week 104 were presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Eye Examination Category
Left eye: Normal (baseline)
|
345 Participants
|
341 Participants
|
|
Eye Examination Category
Left eye: Abnormal NCS (baseline)
|
151 Participants
|
155 Participants
|
|
Eye Examination Category
Left eye: Abnormal CS (baseline)
|
10 Participants
|
8 Participants
|
|
Eye Examination Category
Left eye: Normal (week 104)
|
204 Participants
|
129 Participants
|
|
Eye Examination Category
Left eye: Abnormal NCS (week 104)
|
97 Participants
|
50 Participants
|
|
Eye Examination Category
Left eye: Abnormal CS (week 104)
|
17 Participants
|
6 Participants
|
|
Eye Examination Category
Right eye: Normal (baseline)
|
344 Participants
|
355 Participants
|
|
Eye Examination Category
Right eye: Abnormal NCS (baseline)
|
151 Participants
|
143 Participants
|
|
Eye Examination Category
Right eye: Abnormal CS (baseline)
|
11 Participants
|
6 Participants
|
|
Eye Examination Category
Right eye: Normal (week 104)
|
200 Participants
|
132 Participants
|
|
Eye Examination Category
Right eye: Abnormal NCS (week 104)
|
99 Participants
|
48 Participants
|
|
Eye Examination Category
Right eye: Abnormal CS (week 104)
|
19 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline (within 2 weeks prior to week 0), week 104Population: SAS included all participants receiving at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
The electrocardiogram (ECG) was assessed at baseline (within 2 weeks prior to week 0) and week 104. The investigator interpreted the results and categorised them as: normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 104 are presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
ECG Evaluation
Normal (Baseline)
|
335 Participants
|
335 Participants
|
|
ECG Evaluation
Abnormal NCS (Baseline)
|
162 Participants
|
165 Participants
|
|
ECG Evaluation
Abnormal CS (Baseline)
|
9 Participants
|
4 Participants
|
|
ECG Evaluation
Normal (week 104)
|
227 Participants
|
122 Participants
|
|
ECG Evaluation
Abnormal NCS (week 104)
|
97 Participants
|
65 Participants
|
|
ECG Evaluation
Abnormal CS (week 104)
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: SAS included all participants receiving at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
Change in urine albumin/creatinine ratio from baseline (week 0) to week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Urine Albumin/Creatinine Ratio
|
-1.09 Milligrams per millimole (mg/mmol)
Standard Deviation 7.43
|
-0.74 Milligrams per millimole (mg/mmol)
Standard Deviation 15.58
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
Change in pulse rate from baseline (week 0) to week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Pulse Rate
Week 26
|
2.0 Beats per minute
Standard Deviation 8.8
|
-0.4 Beats per minute
Standard Deviation 8.7
|
|
Change in Pulse Rate
Week 104
|
1.7 Beats per minute
Standard Deviation 9.3
|
-0.5 Beats per minute
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
Change in biochemistry parameter- creatinine, total bilirubin from baseline (week 0) to week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Biochemistry Parameter- Creatinine, Total Bilirubin
Week 26: creatinine
|
-0.50 Micromoles per liter (umol/L)
Standard Deviation 10.08
|
0.25 Micromoles per liter (umol/L)
Standard Deviation 8.78
|
|
Change in Biochemistry Parameter- Creatinine, Total Bilirubin
Week 104: creatinine
|
0.75 Micromoles per liter (umol/L)
Standard Deviation 10.85
|
2.20 Micromoles per liter (umol/L)
Standard Deviation 11.86
|
|
Change in Biochemistry Parameter- Creatinine, Total Bilirubin
Week 26: total bilirubin
|
-0.30 Micromoles per liter (umol/L)
Standard Deviation 3.35
|
-0.32 Micromoles per liter (umol/L)
Standard Deviation 2.80
|
|
Change in Biochemistry Parameter- Creatinine, Total Bilirubin
Week 104: total bilirubin
|
-0.33 Micromoles per liter (umol/L)
Standard Deviation 3.42
|
-0.59 Micromoles per liter (umol/L)
Standard Deviation 3.01
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
Change in biochemistry parameter- albumin from baseline (week 0) to week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Biochemistry Parameter- Albumin
Week 26
|
-0.03 Grams per deciliter (g/dL)
Standard Deviation 0.24
|
-0.03 Grams per deciliter (g/dL)
Standard Deviation 0.21
|
|
Change in Biochemistry Parameter- Albumin
Week 104
|
0.01 Grams per deciliter (g/dL)
Standard Deviation 0.24
|
0.03 Grams per deciliter (g/dL)
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
Change in biochemistry parameters- alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lipase and amylase from baseline (week 0) to week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase
Week 26: ALP
|
-4.16 Units per liter (U/L)
Standard Deviation 14.16
|
-4.33 Units per liter (U/L)
Standard Deviation 12.84
|
|
Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase
Week 104: ALP
|
-1.35 Units per liter (U/L)
Standard Deviation 15.71
|
-1.34 Units per liter (U/L)
Standard Deviation 14.22
|
|
Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase
Week 26: ALT
|
-5.45 Units per liter (U/L)
Standard Deviation 18.50
|
-3.33 Units per liter (U/L)
Standard Deviation 13.24
|
|
Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase
Week 104: ALT
|
-5.39 Units per liter (U/L)
Standard Deviation 14.16
|
-3.45 Units per liter (U/L)
Standard Deviation 14.46
|
|
Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase
Week 26: AST
|
-1.62 Units per liter (U/L)
Standard Deviation 9.78
|
-0.39 Units per liter (U/L)
Standard Deviation 9.51
|
|
Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase
Week 104: AST
|
-1.84 Units per liter (U/L)
Standard Deviation 9.86
|
-0.67 Units per liter (U/L)
Standard Deviation 10.78
|
|
Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase
Week 26: lipase
|
9.26 Units per liter (U/L)
Standard Deviation 42.92
|
-7.97 Units per liter (U/L)
Standard Deviation 34.28
|
|
Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase
Week 104: lipase
|
5.41 Units per liter (U/L)
Standard Deviation 48.35
|
-13.33 Units per liter (U/L)
Standard Deviation 42.27
|
|
Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase
Week 26: amylase
|
9.72 Units per liter (U/L)
Standard Deviation 23.28
|
2.79 Units per liter (U/L)
Standard Deviation 20.92
|
|
Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase
Week 104: amylase
|
7.23 Units per liter (U/L)
Standard Deviation 25.42
|
-0.13 Units per liter (U/L)
Standard Deviation 25.94
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
Change in sodium, potassium and calcium from baseline (week 0) to week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Biochemistry Parameter- Sodium, Potassium and Calcium
Week 26: sodium
|
0.89 mmol/L
Standard Deviation 2.74
|
1.03 mmol/L
Standard Deviation 2.61
|
|
Change in Biochemistry Parameter- Sodium, Potassium and Calcium
Week 104: sodium
|
1.22 mmol/L
Standard Deviation 2.54
|
1.47 mmol/L
Standard Deviation 2.39
|
|
Change in Biochemistry Parameter- Sodium, Potassium and Calcium
Week 26: potassium
|
-0.05 mmol/L
Standard Deviation 0.40
|
-0.08 mmol/L
Standard Deviation 0.42
|
|
Change in Biochemistry Parameter- Sodium, Potassium and Calcium
Week 104: potassium
|
-0.06 mmol/L
Standard Deviation 0.42
|
-0.07 mmol/L
Standard Deviation 0.43
|
|
Change in Biochemistry Parameter- Sodium, Potassium and Calcium
Week 26: calcium
|
-0.01 mmol/L
Standard Deviation 0.11
|
-0.00 mmol/L
Standard Deviation 0.11
|
|
Change in Biochemistry Parameter- Sodium, Potassium and Calcium
Week 104: calcium
|
-0.07 mmol/L
Standard Deviation 0.10
|
-0.06 mmol/L
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
Change in haemoglobin from baseline (week 0) to week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Haematological Parameter- Haemoglobin
Week 26
|
0.08 g/dL
Standard Deviation 0.72
|
0.08 g/dL
Standard Deviation 0.74
|
|
Change in Haematological Parameter- Haemoglobin
Week 104
|
-0.00 g/dL
Standard Deviation 0.89
|
-0.03 g/dL
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
Change in haematocrit from baseline (week 0) to week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Haematological Parameter- Haematocrit
Week 26
|
-0.33 Percentage of red blood cells
Standard Deviation 2.45
|
-0.36 Percentage of red blood cells
Standard Deviation 2.43
|
|
Change in Haematological Parameter- Haematocrit
Week 104
|
-0.71 Percentage of red blood cells
Standard Deviation 2.83
|
-0.95 Percentage of red blood cells
Standard Deviation 3.02
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
Change in erythrocytes from baseline (week 0) to week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Haematological Parameter- Erythrocytes
Week 26
|
-0.02 10^12 cells/L
Standard Deviation 0.28
|
-0.03 10^12 cells/L
Standard Deviation 0.27
|
|
Change in Haematological Parameter- Erythrocytes
Week 104
|
-0.12 10^12 cells/L
Standard Deviation 0.30
|
-0.11 10^12 cells/L
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
Change in thrombocytes and leukocytes from baseline (week 0) to week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Haematological Parameter- Thrombocytes and Leukocytes
Week 26: Thrombocytes
|
8.77 10^9 cells/L
Standard Deviation 35.82
|
7.05 10^9 cells/L
Standard Deviation 41.71
|
|
Change in Haematological Parameter- Thrombocytes and Leukocytes
Week 104: Thrombocytes
|
16.87 10^9 cells/L
Standard Deviation 39.27
|
18.73 10^9 cells/L
Standard Deviation 53.76
|
|
Change in Haematological Parameter- Thrombocytes and Leukocytes
Week 26: Leukocytes
|
0.49 10^9 cells/L
Standard Deviation 1.45
|
0.39 10^9 cells/L
Standard Deviation 1.43
|
|
Change in Haematological Parameter- Thrombocytes and Leukocytes
Week 104: Leukocytes
|
0.07 10^9 cells/L
Standard Deviation 1.50
|
0.32 10^9 cells/L
Standard Deviation 1.55
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
Change in eosinophils from baseline (week 0) to week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Haematological Parameter- Eosinophils
Week 26
|
0.10 Percentage of eosinophils
Standard Deviation 1.88
|
0.06 Percentage of eosinophils
Standard Deviation 2.09
|
|
Change in Haematological Parameter- Eosinophils
Week 104
|
0.32 Percentage of eosinophils
Standard Deviation 2.08
|
0.43 Percentage of eosinophils
Standard Deviation 1.56
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
Change in neutrophils from baseline (week 0) to week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Haematological Parameter- Neutrophils
Week 26
|
1.86 Percentage of neutrophils
Standard Deviation 7.20
|
0.78 Percentage of neutrophils
Standard Deviation 7.68
|
|
Change in Haematological Parameter- Neutrophils
Week 104
|
1.25 Percentage of neutrophils
Standard Deviation 7.94
|
1.21 Percentage of neutrophils
Standard Deviation 8.02
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
Change in basophils from baseline (week 0) to week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Haematological Parameter- Basophils
Week 26
|
0.00 Percentage of basophils
Standard Deviation 0.28
|
-0.00 Percentage of basophils
Standard Deviation 0.29
|
|
Change in Haematological Parameter- Basophils
Week 104
|
0.20 Percentage of basophils
Standard Deviation 0.38
|
0.16 Percentage of basophils
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
Change in monocytes from baseline (week 0) to week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Haematological Parameter- Monocytes
Week 26
|
-0.10 Percentage of monocytes
Standard Deviation 2.04
|
0.01 Percentage of monocytes
Standard Deviation 1.91
|
|
Change in Haematological Parameter- Monocytes
Week 104
|
0.49 Percentage of monocytes
Standard Deviation 2.02
|
0.59 Percentage of monocytes
Standard Deviation 1.88
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
Change in lymphocytes from baseline (week 0) to week 26 and week 104 is presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Haematological Parameter- Lymphocytes
Week 26
|
-1.87 Percentage of lymphocytes
Standard Deviation 6.29
|
-0.84 Percentage of lymphocytes
Standard Deviation 6.73
|
|
Change in Haematological Parameter- Lymphocytes
Week 104
|
-2.25 Percentage of lymphocytes
Standard Deviation 6.76
|
-2.38 Percentage of lymphocytes
Standard Deviation 7.29
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.
The number of participants who reported low, normal and high levels of calcitonin in relation to reference ranges at baseline (week 0), week 26 and week 104 are presented.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Calcitonin
Week 0: Low
|
0 Participants
|
0 Participants
|
|
Change in Calcitonin
Week 0: Normal
|
481 Participants
|
472 Participants
|
|
Change in Calcitonin
Week 0: High
|
25 Participants
|
32 Participants
|
|
Change in Calcitonin
Week 26: Low
|
0 Participants
|
0 Participants
|
|
Change in Calcitonin
Week 26: Normal
|
437 Participants
|
431 Participants
|
|
Change in Calcitonin
Week 26: High
|
40 Participants
|
30 Participants
|
|
Change in Calcitonin
Week 104: Low
|
0 Participants
|
0 Participants
|
|
Change in Calcitonin
Week 104: Normal
|
301 Participants
|
169 Participants
|
|
Change in Calcitonin
Week 104: High
|
31 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in the sub-domain scores and component summary (PCS and MCS) scores are presented. A positive change score indicates an improvement since baseline.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
Week 26: Physical functioning
|
1.2 Score on a scale
Standard Deviation 6.8
|
1.1 Score on a scale
Standard Deviation 7.0
|
|
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
Week 104: Physical functioning
|
0.7 Score on a scale
Standard Deviation 7.5
|
0.6 Score on a scale
Standard Deviation 7.9
|
|
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
Week 26: Role-physical
|
1.4 Score on a scale
Standard Deviation 7.7
|
0.5 Score on a scale
Standard Deviation 7.4
|
|
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
Week 104: Role-physical
|
1.4 Score on a scale
Standard Deviation 8.7
|
0.7 Score on a scale
Standard Deviation 7.5
|
|
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
Week 26: Bodily pain
|
1.5 Score on a scale
Standard Deviation 9.7
|
0.4 Score on a scale
Standard Deviation 10.0
|
|
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
Week 104: Bodily pain
|
1.6 Score on a scale
Standard Deviation 11.2
|
0.1 Score on a scale
Standard Deviation 8.5
|
|
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
Week 26: General health
|
2.5 Score on a scale
Standard Deviation 8.2
|
2.1 Score on a scale
Standard Deviation 7.6
|
|
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
Week 104: General health
|
2.3 Score on a scale
Standard Deviation 8.7
|
2.1 Score on a scale
Standard Deviation 8.3
|
|
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
Week 26: Vitality
|
1.4 Score on a scale
Standard Deviation 8.1
|
1.4 Score on a scale
Standard Deviation 8.0
|
|
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
Week 104: Vitality
|
1.5 Score on a scale
Standard Deviation 8.4
|
1.5 Score on a scale
Standard Deviation 8.0
|
|
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
Week 26: Social functioning
|
1.8 Score on a scale
Standard Deviation 8.1
|
0.9 Score on a scale
Standard Deviation 8.8
|
|
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
Week 104: Social functioning
|
0.9 Score on a scale
Standard Deviation 8.9
|
1.1 Score on a scale
Standard Deviation 7.6
|
|
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
Week 26: Role-emotional
|
0.6 Score on a scale
Standard Deviation 8.9
|
0.7 Score on a scale
Standard Deviation 8.8
|
|
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
Week 104: Role-emotional
|
1.6 Score on a scale
Standard Deviation 10.1
|
1.2 Score on a scale
Standard Deviation 8.2
|
|
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
Week 26: Mental health
|
1.7 Score on a scale
Standard Deviation 8.7
|
1.3 Score on a scale
Standard Deviation 8.4
|
|
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
Week 104: Mental health
|
2.5 Score on a scale
Standard Deviation 9.4
|
0.3 Score on a scale
Standard Deviation 8.9
|
|
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
Week 26: PCS
|
1.6 Score on a scale
Standard Deviation 6.3
|
0.9 Score on a scale
Standard Deviation 6.3
|
|
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
Week 104: PCS
|
1.0 Score on a scale
Standard Deviation 7.2
|
0.8 Score on a scale
Standard Deviation 6.0
|
|
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
Week 26: MCS
|
1.3 Score on a scale
Standard Deviation 8.2
|
1.2 Score on a scale
Standard Deviation 8.0
|
|
Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)
Week 104: MCS
|
2.0 Score on a scale
Standard Deviation 9.0
|
1.0 Score on a scale
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Week 0, week 26, week 104Population: FAS included all randomised participants. 'Number analyzed'=participants with available data.
Treatment related impact measures-diabetes (TRIM-D) was developed according to the FDA guidance from 2009 on development of new PRO measures. The questionnaire consists of 5 sub-domains, which are scored according to a 1-5 point scale with a higher score indicating a better health state (less negative impact). Sub-domain scores are calculated by summing across items in the same sub-domain, and the total score is calculated by summing scores from all the sub-domains. The highest possible summed score within a sub-domain ranges from 20 (compliance sub-domain) to 40 (psychological health sub-domain) points and the highest possible total score is 140 points. Change in TRIM-D total score from baseline (week 0) to week 26 and week 104 is presented. A positive change score indicates an improvement since baseline.
Outcome measures
| Measure |
Insulin Degludec/Liraglutide
n=506 Participants
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=506 Participants
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Change in TRIM-D
Week 26
|
9.6 Score on a scale
Standard Deviation 12.4
|
7.3 Score on a scale
Standard Deviation 13.1
|
|
Change in TRIM-D
Week 104
|
11.4 Score on a scale
Standard Deviation 13.7
|
9.5 Score on a scale
Standard Deviation 12.8
|
Adverse Events
Insulin Degludec/Liraglutide
Serious events: 60 serious events
Other events: 206 other events
Deaths: 2 deaths
Insulin Glargine
Serious events: 43 serious events
Other events: 156 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Insulin Degludec/Liraglutide
n=506 participants at risk
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 participants at risk
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.59%
3/506 • Number of events 3 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.40%
2/504 • Number of events 2 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Cardiac disorders
Angina unstable
|
0.79%
4/506 • Number of events 4 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Vascular disorders
Aortic stenosis
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.40%
2/504 • Number of events 2 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.40%
2/504 • Number of events 2 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign hepatic neoplasm
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Infections and infestations
Bronchitis
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.40%
2/504 • Number of events 2 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.40%
2/504 • Number of events 2 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.40%
2/504 • Number of events 4 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
General disorders
Chest pain
|
0.40%
2/506 • Number of events 3 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.59%
3/506 • Number of events 3 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.40%
2/506 • Number of events 2 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.60%
3/504 • Number of events 3 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.40%
2/504 • Number of events 2 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Cardiac disorders
Coronary artery disease
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Infections and infestations
Dacryocystitis
|
0.20%
1/506 • Number of events 2 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Psychiatric disorders
Depression
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Eye disorders
Diabetic retinopathy
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Eye disorders
Diplopia
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Nervous system disorders
Dizziness
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Fall
|
0.59%
3/506 • Number of events 3 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Gastrointestinal disorders
Gastritis
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.20%
1/506 • Number of events 2 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Infections and infestations
Helicobacter gastritis
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Vascular disorders
Hypertension
|
0.40%
2/506 • Number of events 2 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.20%
1/506 • Number of events 2 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Infections and infestations
Influenza
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Nervous system disorders
Ischaemic stroke
|
0.40%
2/506 • Number of events 2 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.59%
3/506 • Number of events 3 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Lung perforation
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Eye disorders
Macular degeneration
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.40%
2/506 • Number of events 2 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Cardiac disorders
Myocardial infarction
|
0.40%
2/506 • Number of events 2 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 2 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Gastrointestinal disorders
Nausea
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.40%
2/506 • Number of events 3 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
General disorders
Non-cardiac chest pain
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.40%
2/504 • Number of events 2 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.79%
4/506 • Number of events 4 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.60%
3/504 • Number of events 3 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Infections and infestations
Osteomyelitis
|
0.40%
2/506 • Number of events 2 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.59%
3/506 • Number of events 3 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Peripheral arterial reocclusion
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.40%
2/506 • Number of events 2 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Infections and infestations
Pneumonia
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 2 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Renal and urinary disorders
Renal failure
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Respiratory fume inhalation disorder
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.40%
2/506 • Number of events 2 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Nervous system disorders
Seizure
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Infections and infestations
Sepsis
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.40%
2/504 • Number of events 2 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Surgical and medical procedures
Tympanoplasty
|
0.20%
1/506 • Number of events 2 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Vascular disorders
Vasoconstriction
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.20%
1/506 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Infections and infestations
Viral infection
|
0.00%
0/506 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.20%
1/504 • Number of events 1 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Gastrointestinal disorders
Vomiting
|
0.20%
1/506 • Number of events 2 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
0.00%
0/504 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
Other adverse events
| Measure |
Insulin Degludec/Liraglutide
n=506 participants at risk
Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).
|
Insulin Glargine
n=504 participants at risk
Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.7%
24/506 • Number of events 27 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
5.8%
29/504 • Number of events 36 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.9%
25/506 • Number of events 30 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
5.4%
27/504 • Number of events 40 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
39/506 • Number of events 52 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
2.4%
12/504 • Number of events 14 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Nervous system disorders
Headache
|
11.5%
58/506 • Number of events 98 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
8.9%
45/504 • Number of events 89 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Infections and infestations
Influenza
|
7.1%
36/506 • Number of events 46 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
5.6%
28/504 • Number of events 38 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Infections and infestations
Nasopharyngitis
|
11.3%
57/506 • Number of events 71 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
8.7%
44/504 • Number of events 53 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Gastrointestinal disorders
Nausea
|
6.1%
31/506 • Number of events 39 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
1.6%
8/504 • Number of events 9 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.5%
28/506 • Number of events 30 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
7.1%
36/504 • Number of events 44 • Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.
|
Additional Information
Clinical Reporting Anchor and Disclosure (1452)
Novo Nordisk A/S
Phone: (+1) 866-867-7178
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER