Trial Outcomes & Findings for GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin (NCT NCT00763451)
NCT ID: NCT00763451
Last Updated: 2016-12-14
Results Overview
Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required. The "Placebo (Two-step Titration)" and "Placebo (One-step Titration)" Arms/Groups were combined as pre-specified in the study protocol
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
484 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2016-12-14
Participant Flow
The study was conducted at 75 centers in 15 countries between September 29, 2008 and January 27, 2011. The overall duration of treatment was at least 76 weeks (24 weeks main double-blind treatment; variable double-blind extension treatment).
A total of 884 patients were screened of which 400 (45.2%) were screen failures; main reason for screen failure was glycosylated hemoglobin (HbA1c) values being out of the defined protocol range (greater than or equal to 7 percent \[%\] and less than or equal to 10%). A total of 484 patients were randomized.
Participant milestones
| Measure |
Placebo (Two-Step Titration)
2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
|
Placebo (One-Step Titration)
1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
|
Lixisenatide (Two-Step Titration)
2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
|
Lixisenatide (One-Step Titration)
1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
80
|
82
|
161
|
161
|
|
Overall Study
Treated/Safety Population
|
79
|
81
|
161
|
161
|
|
Overall Study
Modified Intent-to-Treat(mITT)Population
|
79
|
80
|
160
|
160
|
|
Overall Study
COMPLETED
|
67
|
60
|
121
|
131
|
|
Overall Study
NOT COMPLETED
|
13
|
22
|
40
|
30
|
Reasons for withdrawal
| Measure |
Placebo (Two-Step Titration)
2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
|
Placebo (One-Step Titration)
1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
|
Lixisenatide (Two-Step Titration)
2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
|
Lixisenatide (One-Step Titration)
1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
6
|
19
|
14
|
|
Overall Study
Lack of Efficacy
|
1
|
4
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
6
|
9
|
7
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
|
Overall Study
Poor Compliance to Protocol
|
1
|
1
|
2
|
2
|
|
Overall Study
Familial and Personal Reasons
|
5
|
3
|
5
|
4
|
|
Overall Study
Randomized but not Treated
|
1
|
1
|
0
|
0
|
|
Overall Study
Study Site Reason
|
0
|
1
|
1
|
1
|
Baseline Characteristics
GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin
Baseline characteristics by cohort
| Measure |
Placebo (Two-step Titration)
n=79 Participants
2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
|
Placebo (One-step Titration)
n=81 Participants
1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
|
Lixisenatide (Two-step Titration)
n=161 Participants
2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
|
Lixisenatide (One-step Titration)
n=161 Participants
1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
|
Total
n=482 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.9 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
57.5 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
54.6 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
55.4 years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
56.1 years
STANDARD_DEVIATION 9.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
267 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
215 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race: Caucasian/White
|
72 participants
n=5 Participants
|
76 participants
n=7 Participants
|
146 participants
n=5 Participants
|
141 participants
n=4 Participants
|
435 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race: Black
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race: Asian/Oriental
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
13 participants
n=4 Participants
|
33 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race: Other
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Hispanic
|
24 participants
n=5 Participants
|
22 participants
n=7 Participants
|
55 participants
n=5 Participants
|
44 participants
n=4 Participants
|
145 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Non Hispanic
|
55 participants
n=5 Participants
|
59 participants
n=7 Participants
|
106 participants
n=5 Participants
|
117 participants
n=4 Participants
|
337 participants
n=21 Participants
|
|
Glycosylated Hemoglobin (HbA1c)
|
8.03 percentage of hemoglobin
STANDARD_DEVIATION 0.81 • n=5 Participants
|
8.02 percentage of hemoglobin
STANDARD_DEVIATION 0.84 • n=7 Participants
|
8.10 percentage of hemoglobin
STANDARD_DEVIATION 0.88 • n=5 Participants
|
7.99 percentage of hemoglobin
STANDARD_DEVIATION 0.87 • n=4 Participants
|
8.04 percentage of hemoglobin
STANDARD_DEVIATION 0.86 • n=21 Participants
|
|
Fasting Plasma Glucose (FPG)
|
9.60 millimole per liter (mmol/L)
STANDARD_DEVIATION 2.06 • n=5 Participants
|
9.31 millimole per liter (mmol/L)
STANDARD_DEVIATION 1.82 • n=7 Participants
|
9.54 millimole per liter (mmol/L)
STANDARD_DEVIATION 2.50 • n=5 Participants
|
9.56 millimole per liter (mmol/L)
STANDARD_DEVIATION 2.02 • n=4 Participants
|
9.52 millimole per liter (mmol/L)
STANDARD_DEVIATION 2.17 • n=21 Participants
|
|
Body Weight
|
87.45 kilogram
STANDARD_DEVIATION 16.32 • n=5 Participants
|
88.28 kilogram
STANDARD_DEVIATION 18.43 • n=7 Participants
|
87.41 kilogram
STANDARD_DEVIATION 16.90 • n=5 Participants
|
90.21 kilogram
STANDARD_DEVIATION 18.95 • n=4 Participants
|
88.50 kilogram
STANDARD_DEVIATION 17.77 • n=21 Participants
|
|
Duration of Diabetes
|
6.68 years
STANDARD_DEVIATION 5.33 • n=5 Participants
|
5.77 years
STANDARD_DEVIATION 4.00 • n=7 Participants
|
6.01 years
STANDARD_DEVIATION 4.60 • n=5 Participants
|
5.77 years
STANDARD_DEVIATION 3.85 • n=4 Participants
|
6.00 years
STANDARD_DEVIATION 4.40 • n=21 Participants
|
|
Body Mass Index (BMI)
|
32.38 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 5.04 • n=5 Participants
|
32.35 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 5.86 • n=7 Participants
|
32.06 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 4.84 • n=5 Participants
|
32.99 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 5.80 • n=4 Participants
|
32.47 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 5.38 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.
Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required. The "Placebo (Two-step Titration)" and "Placebo (One-step Titration)" Arms/Groups were combined as pre-specified in the study protocol
Outcome measures
| Measure |
Placebo (Combined)
n=158 Participants
Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
|
Lixisenatide (Two-Step Titration)
n=152 Participants
2-step initiation regimen of lixisenatide.
|
Lixisenatide (One-Step Titration)
n=156 Participants
1-step initiation regimen of lixisenatide.
|
|---|---|---|---|
|
Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
|
-0.42 percentage of hemoglobin
Standard Error 0.099
|
-0.83 percentage of hemoglobin
Standard Error 0.099
|
-0.92 percentage of hemoglobin
Standard Error 0.101
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.The "Placebo (Two-step Titration)"and"Placebo (One-step Titration)"Arms/Groups were combined as pre-specified in the study protocol
Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Outcome measures
| Measure |
Placebo (Combined)
n=158 Participants
Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
|
Lixisenatide (Two-Step Titration)
n=160 Participants
2-step initiation regimen of lixisenatide.
|
Lixisenatide (One-Step Titration)
n=158 Participants
1-step initiation regimen of lixisenatide.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
|
0.11 mmol/L
Standard Error 0.209
|
-0.56 mmol/L
Standard Error 0.208
|
-0.53 mmol/L
Standard Error 0.212
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.The "Placebo (Two-step Titration)" and "Placebo (One-step Titration)" Arms/Groups were combined as pre-specified in the study protocol
Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Outcome measures
| Measure |
Placebo (Combined)
n=158 Participants
Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
|
Lixisenatide (Two-Step Titration)
n=155 Participants
2-step initiation regimen of lixisenatide.
|
Lixisenatide (One-Step Titration)
n=158 Participants
1-step initiation regimen of lixisenatide.
|
|---|---|---|---|
|
Change From Baseline in Body Weight at Week 24
|
-1.63 kilogram
Standard Error 0.385
|
-2.68 kilogram
Standard Error 0.385
|
-2.63 kilogram
Standard Error 0.389
|
SECONDARY outcome
Timeframe: Week 24Population: mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.The "Placebo (Two-step Titration)" and "Placebo (One-step Titration)" Arms/Groups were combined as pre-specified in the study protocol
The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Outcome measures
| Measure |
Placebo (Combined)
n=158 Participants
Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
|
Lixisenatide (Two-Step Titration)
n=152 Participants
2-step initiation regimen of lixisenatide.
|
Lixisenatide (One-Step Titration)
n=156 Participants
1-step initiation regimen of lixisenatide.
|
|---|---|---|---|
|
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24
|
24.1 percentage of participants
|
42.1 percentage of participants
|
47.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.The "Placebo (Two-step Titration)" and "Placebo (One-step Titration)" Arms/Groups were combined as pre-specified in the study protocol
The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Outcome measures
| Measure |
Placebo (Combined)
n=158 Participants
Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
|
Lixisenatide (Two-Step Titration)
n=152 Participants
2-step initiation regimen of lixisenatide.
|
Lixisenatide (One-Step Titration)
n=156 Participants
1-step initiation regimen of lixisenatide.
|
|---|---|---|---|
|
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24
|
7.6 percentage of participants
|
20.4 percentage of participants
|
25.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: mITT population. The "Placebo (Two-step Titration)" and "Placebo (One-step Titration)" Arms/Groups were combined as pre-specified in the study protocol
Routine fasting self-measured plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG \>270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG \>240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG \>200 mg/dL (11.1 mmol/L) or HbA1c \>8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Outcome measures
| Measure |
Placebo (Combined)
n=159 Participants
Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
|
Lixisenatide (Two-Step Titration)
n=160 Participants
2-step initiation regimen of lixisenatide.
|
Lixisenatide (One-Step Titration)
n=160 Participants
1-step initiation regimen of lixisenatide.
|
|---|---|---|---|
|
Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period
|
4.4 percentage of participants
|
3.1 percentage of participants
|
1.3 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 24Population: mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.The "Placebo (Two-step Titration)" and "Placebo (One-step Titration)" Arms/Groups were combined as pre-specified in the study protocol
The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Outcome measures
| Measure |
Placebo (Combined)
n=158 Participants
Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
|
Lixisenatide (Two-Step Titration)
n=155 Participants
2-step initiation regimen of lixisenatide.
|
Lixisenatide (One-Step Titration)
n=158 Participants
1-step initiation regimen of lixisenatide.
|
|---|---|---|---|
|
Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24
|
15.2 percentage of participants
|
25.8 percentage of participants
|
19.6 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: First dose of study drug up to 3 days after the last dose administration, for up to 112 weeksPopulation: Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.The "Placebo (Two-step Titration)" and "Placebo (One-step Titration)" Arms/Groups were combined as pre-specified in the study protocol
Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.
Outcome measures
| Measure |
Placebo (Combined)
n=160 Participants
Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
|
Lixisenatide (Two-Step Titration)
n=161 Participants
2-step initiation regimen of lixisenatide.
|
Lixisenatide (One-Step Titration)
n=161 Participants
1-step initiation regimen of lixisenatide.
|
|---|---|---|---|
|
Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia
Symptomatic hypoglycemia
|
12 participants
|
12 participants
|
6 participants
|
|
Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia
Severe symptomatic hypoglycemia
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Placebo (Two-step Titration)
Serious events: 13 serious events
Other events: 51 other events
Deaths: 0 deaths
Placebo (One-step Titration)
Serious events: 9 serious events
Other events: 53 other events
Deaths: 0 deaths
Placebo (Combined)
Serious events: 22 serious events
Other events: 104 other events
Deaths: 0 deaths
Lixisenatide (Two-step Titration)
Serious events: 21 serious events
Other events: 119 other events
Deaths: 0 deaths
Lixisenatide One-step Titration
Serious events: 16 serious events
Other events: 101 other events
Deaths: 0 deaths
Lixisenatide (Combined)
Serious events: 37 serious events
Other events: 220 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Two-step Titration)
n=79 participants at risk
2-step initiation regimen of volume matching placebo.
|
Placebo (One-step Titration)
n=81 participants at risk
1-step initiation regimen of volume matching placebo.
|
Placebo (Combined)
n=160 participants at risk
Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
|
Lixisenatide (Two-step Titration)
n=161 participants at risk
2-step initiation regimen of lixisenatide.
|
Lixisenatide One-step Titration
n=161 participants at risk
1-step initiation regimen of lixisenatide.
|
Lixisenatide (Combined)
n=322 participants at risk
Included all patients who received 2-step initiation regimen of lixisenatide and 1-step initiation regimen of lixisenatide.
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.2%
1/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.2%
1/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Infections and infestations
Pneumonia
|
1.3%
1/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.2%
1/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.2%
2/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Infections and infestations
Septic shock
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.2%
1/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
2/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Endocrine disorders
Goitre
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.2%
2/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
2/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Psychiatric disorders
Depression
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.2%
2/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
2/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.2%
1/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Coma
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.2%
1/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.2%
1/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.2%
2/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
2/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Cardiac disorders
Adams-Stokes syndrome
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
1/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
2/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.2%
1/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Cardiac disorders
Coronary artery stenosis
|
1.3%
1/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.2%
1/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Vascular disorders
Hypertension
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.3%
1/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Gastritis
|
1.3%
1/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.3%
1/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.2%
1/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.3%
1/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
1.3%
1/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.3%
1/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
1.3%
1/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Investigations
Blood calcitonin increased
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Investigations
Pancreatic enzymes increased
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.3%
1/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
1.3%
1/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.2%
1/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
1.3%
1/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.31%
1/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
1.3%
1/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
Other adverse events
| Measure |
Placebo (Two-step Titration)
n=79 participants at risk
2-step initiation regimen of volume matching placebo.
|
Placebo (One-step Titration)
n=81 participants at risk
1-step initiation regimen of volume matching placebo.
|
Placebo (Combined)
n=160 participants at risk
Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
|
Lixisenatide (Two-step Titration)
n=161 participants at risk
2-step initiation regimen of lixisenatide.
|
Lixisenatide One-step Titration
n=161 participants at risk
1-step initiation regimen of lixisenatide.
|
Lixisenatide (Combined)
n=322 participants at risk
Included all patients who received 2-step initiation regimen of lixisenatide and 1-step initiation regimen of lixisenatide.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Bronchitis
|
7.6%
6/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
8.6%
7/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
8.1%
13/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.9%
3/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
4.3%
7/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
3.1%
10/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Infections and infestations
Gastroenteritis
|
8.9%
7/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
2.5%
2/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
5.6%
9/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
2.5%
4/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
4.3%
7/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
3.4%
11/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Infections and infestations
Influenza
|
11.4%
9/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
11.1%
9/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
11.2%
18/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
12.4%
20/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
6.8%
11/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
9.6%
31/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Infections and infestations
Nasopharyngitis
|
16.5%
13/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
9.9%
8/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
13.1%
21/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
9.9%
16/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
11.2%
18/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
10.6%
34/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Infections and infestations
Pharyngitis
|
7.6%
6/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
7.4%
6/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
7.5%
12/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
5.6%
9/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
6.2%
10/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
5.9%
19/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.1%
4/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
6.2%
5/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
5.6%
9/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
2.5%
4/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
3.7%
6/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
3.1%
10/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Infections and infestations
Urinary tract infection
|
7.6%
6/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
6.2%
5/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
6.9%
11/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
6.8%
11/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
6.2%
10/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
6.5%
21/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.1%
4/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
2.5%
4/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
2.5%
4/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.6%
5/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
10.1%
8/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
6.2%
5/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
8.1%
13/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
7.5%
12/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
3.7%
6/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
5.6%
18/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Dizziness
|
13.9%
11/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
12.3%
10/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
13.1%
21/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
11.8%
19/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
9.3%
15/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
10.6%
34/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Headache
|
13.9%
11/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
11.1%
9/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
12.5%
20/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
14.3%
23/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
12.4%
20/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
13.4%
43/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Vascular disorders
Hypertension
|
2.5%
2/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
12.3%
10/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
7.5%
12/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
7.5%
12/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
5.6%
9/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
6.5%
21/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
3/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
4.9%
4/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
4.4%
7/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
5.6%
9/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
5.0%
8/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
5.3%
17/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Constipation
|
3.8%
3/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.9%
3/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
6.8%
11/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.2%
2/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
4.0%
13/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.7%
10/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
13.6%
11/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
13.1%
21/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
14.9%
24/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
9.9%
16/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
12.4%
40/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.2%
1/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
4.3%
7/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
5.6%
9/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
5.0%
16/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Gastritis
|
5.1%
4/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
2.5%
4/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
5.0%
8/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
4.3%
7/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
4.7%
15/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Nausea
|
10.1%
8/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
6.2%
5/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
8.1%
13/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
37.9%
61/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
29.2%
47/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
33.5%
108/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.00%
0/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
18.0%
29/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
13.0%
21/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
15.5%
50/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.4%
9/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
6.2%
5/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
8.8%
14/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
6.8%
11/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
5.6%
9/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
6.2%
20/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.1%
8/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
3.7%
3/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
6.9%
11/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
9.3%
15/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
11.2%
18/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
10.2%
33/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.1%
4/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
4.9%
4/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
5.0%
8/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.2%
2/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
2.5%
4/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.9%
6/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.1%
4/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
2.5%
2/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
3.8%
6/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
2.5%
4/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
3.1%
5/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
2.8%
9/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.3%
5/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
3.7%
3/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
5.0%
8/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
2.5%
4/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.9%
3/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
2.2%
7/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
General disorders
Asthenia
|
0.00%
0/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.2%
1/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.62%
1/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
5.6%
9/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.9%
3/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
3.7%
12/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
|
General disorders
Oedema peripheral
|
5.1%
4/79 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
3.7%
3/81 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
4.4%
7/160 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.9%
3/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.9%
3/161 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
1.9%
6/322 • First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks
Median exposure to study treatment was 567, 588 and 589 days in lixisenatide two step titration, one step titration and placebo combined arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER