Trial Outcomes & Findings for GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy (NCT NCT00688701)
NCT ID: NCT00688701
Last Updated: 2016-12-12
Results Overview
Absolute change = HbA1c value at Week 12 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. 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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
361 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2016-12-12
Participant Flow
The study was conducted at 61 centers (68 were initiated) in 12 countries between May 14, 2008 and December 14, 2009.
A total of 795 patients were screened of which 434 (54.6%) 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% and less than or equal to 10%). A total of 361 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 Week 12.
|
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 Week 12.
|
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 Week 12.
|
Lixisenatide (One-Step Titration)
1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
61
|
61
|
120
|
119
|
|
Overall Study
Treated/Safety Population
|
61
|
61
|
120
|
119
|
|
Overall Study
Modified Intent-to-Treat(mITT)Population
|
61
|
60
|
120
|
118
|
|
Overall Study
Subgroup for Standardized Meal Test
|
27
|
35
|
60
|
65
|
|
Overall Study
COMPLETED
|
57
|
56
|
110
|
108
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
10
|
11
|
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 Week 12.
|
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 Week 12.
|
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 Week 12.
|
Lixisenatide (One-Step Titration)
1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
5
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
4
|
8
|
|
Overall Study
Poor compliance to protocol
|
0
|
1
|
1
|
0
|
Baseline Characteristics
GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy
Baseline characteristics by cohort
| Measure |
Placebo (Combined)
n=122 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=120 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 Week 12.
|
Lixisenatide (One-Step Titration)
n=119 Participants
1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12.
|
Total
n=361 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
53.8 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
53.7 years
STANDARD_DEVIATION 10.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
186 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race: Caucasian/White
|
90 participants
n=5 Participants
|
88 participants
n=7 Participants
|
85 participants
n=5 Participants
|
263 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race: Black
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race: Asian/Oriental
|
24 participants
n=5 Participants
|
27 participants
n=7 Participants
|
29 participants
n=5 Participants
|
80 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race: Other
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
2 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Hispanic
|
31 participants
n=5 Participants
|
25 participants
n=7 Participants
|
22 participants
n=5 Participants
|
78 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Non Hispanic
|
91 participants
n=5 Participants
|
95 participants
n=7 Participants
|
97 participants
n=5 Participants
|
283 participants
n=4 Participants
|
|
Glycosylated Hemoglobin (HbA1c)
|
8.07 percentage of hemoglobin
STANDARD_DEVIATION 0.91 • n=5 Participants
|
7.98 percentage of hemoglobin
STANDARD_DEVIATION 0.92 • n=7 Participants
|
8.07 percentage of hemoglobin
STANDARD_DEVIATION 0.87 • n=5 Participants
|
8.04 percentage of hemoglobin
STANDARD_DEVIATION 0.90 • n=4 Participants
|
|
2-Hour Postprandial Plasma Glucose (PPG)
|
14.27 mmol/L
STANDARD_DEVIATION 4.84 • n=5 Participants
|
14.81 mmol/L
STANDARD_DEVIATION 3.87 • n=7 Participants
|
14.62 mmol/L
STANDARD_DEVIATION 3.41 • n=5 Participants
|
14.57 mmol/L
STANDARD_DEVIATION 4.05 • n=4 Participants
|
|
Body Weight
|
86.08 kilogram (kg)
STANDARD_DEVIATION 22.21 • n=5 Participants
|
89.04 kilogram (kg)
STANDARD_DEVIATION 22.16 • n=7 Participants
|
86.50 kilogram (kg)
STANDARD_DEVIATION 21.00 • n=5 Participants
|
87.20 kilogram (kg)
STANDARD_DEVIATION 21.78 • n=4 Participants
|
|
Fasting Plasma Glucose (FPG)
|
8.90 millimole per liter (mmol/L)
STANDARD_DEVIATION 2.16 • n=5 Participants
|
9.15 millimole per liter (mmol/L)
STANDARD_DEVIATION 1.99 • n=7 Participants
|
9.04 millimole per liter (mmol/L)
STANDARD_DEVIATION 1.97 • n=5 Participants
|
9.03 millimole per liter (mmol/L)
STANDARD_DEVIATION 2.04 • n=4 Participants
|
|
Glucose Excursion
|
4.82 mmol/L
STANDARD_DEVIATION 3.69 • n=5 Participants
|
5.67 mmol/L
STANDARD_DEVIATION 3.05 • n=7 Participants
|
5.34 mmol/L
STANDARD_DEVIATION 2.96 • n=5 Participants
|
5.27 mmol/L
STANDARD_DEVIATION 3.25 • n=4 Participants
|
|
Duration of Diabetes
|
1.37 years
n=5 Participants
|
1.42 years
n=7 Participants
|
1.11 years
n=5 Participants
|
1.33 years
n=4 Participants
|
|
Body Mass Index (BMI)
|
31.76 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 6.69 • n=5 Participants
|
32.34 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 6.72 • n=7 Participants
|
31.65 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 6.62 • n=5 Participants
|
31.91 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 6.66 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: 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 12 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. 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=112 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=113 Participants
2-step initiation regimen of lixisenatide.
|
Lixisenatide (One-Step Titration)
n=114 Participants
1-step initiation regimen of lixisenatide.
|
|---|---|---|---|
|
Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
|
-0.19 percentage of hemoglobin
Standard Error 0.121
|
-0.73 percentage of hemoglobin
Standard Error 0.116
|
-0.85 percentage of hemoglobin
Standard Error 0.119
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Subgroup for standardized meal test. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.
The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal (performed in selected sites). Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. 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=54 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=53 Participants
2-step initiation regimen of lixisenatide.
|
Lixisenatide (One-Step Titration)
n=62 Participants
1-step initiation regimen of lixisenatide.
|
|---|---|---|---|
|
Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 12
|
-0.65 mmol/L
Standard Error 0.563
|
-4.51 mmol/L
Standard Error 0.572
|
-5.47 mmol/L
Standard Error 0.549
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: 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.
Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. 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=116 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=117 Participants
2-step initiation regimen of lixisenatide.
|
Lixisenatide (One-Step Titration)
n=115 Participants
1-step initiation regimen of lixisenatide.
|
|---|---|---|---|
|
Change From Baseline in Body Weight at Week 12
|
-1.98 kilogram
Standard Error 0.341
|
-1.96 kilogram
Standard Error 0.326
|
-1.92 kilogram
Standard Error 0.338
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.
Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. 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=121 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=119 Participants
2-step initiation regimen of lixisenatide.
|
Lixisenatide (One-Step Titration)
n=118 Participants
1-step initiation regimen of lixisenatide.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
|
0.19 mmol/L
Standard Error 0.255
|
-0.68 mmol/L
Standard Error 0.247
|
-0.89 mmol/L
Standard Error 0.254
|
SECONDARY outcome
Timeframe: Week 12Population: mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.
The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. 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=112 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=113 Participants
2-step initiation regimen of lixisenatide.
|
Lixisenatide (One-Step Titration)
n=114 Participants
1-step initiation regimen of lixisenatide.
|
|---|---|---|---|
|
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 12
|
26.8 percentage of participants
|
52.2 percentage of participants
|
46.5 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.
The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. 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=112 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=113 Participants
2-step initiation regimen of lixisenatide.
|
Lixisenatide (One-Step Titration)
n=114 Participants
1-step initiation regimen of lixisenatide.
|
|---|---|---|---|
|
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 12
|
12.5 percentage of participants
|
31.9 percentage of participants
|
25.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: mITT population.
Routine fasting self monitored plasma glucose (SMPG) and central laboratory FPG 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 was performed. Threshold values for fasting SMPG/FPG: from baseline to Week 8: \>270 milligram/deciliter (mg/dL) (15 mmol/L) and from Week 8 to Week 12: \>240 mg/dL (13.3 mmol/L). 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=121 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=120 Participants
2-step initiation regimen of lixisenatide.
|
Lixisenatide (One-Step Titration)
n=118 Participants
1-step initiation regimen of lixisenatide.
|
|---|---|---|---|
|
Percentage of Patients Requiring Rescue Therapy During the Double-Blind Treatment Period
|
2.5 percentage of participants
|
1.7 percentage of participants
|
0.8 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12Population: Subgroup for standardized meal test. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.
Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test (performed in selected sites), before study drug administration. Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. 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=54 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=53 Participants
2-step initiation regimen of lixisenatide.
|
Lixisenatide (One-Step Titration)
n=62 Participants
1-step initiation regimen of lixisenatide.
|
|---|---|---|---|
|
Change From Baseline in Glucose Excursion at Week 12
|
-0.67 mmol/L
Standard Error 0.447
|
-3.77 mmol/L
Standard Error 0.454
|
-4.36 mmol/L
Standard Error 0.436
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12Population: mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.
The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. 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=116 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=117 Participants
2-step initiation regimen of lixisenatide.
|
Lixisenatide (One-Step Titration)
n=115 Participants
1-step initiation regimen of lixisenatide.
|
|---|---|---|---|
|
Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 12
|
17.2 percentage of participants
|
16.2 percentage of participants
|
18.3 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: First dose of study drug up to 3 days after the last dose administrationPopulation: Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
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=122 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=120 Participants
2-step initiation regimen of lixisenatide.
|
Lixisenatide (One-Step Titration)
n=119 Participants
1-step initiation regimen of lixisenatide.
|
|---|---|---|---|
|
Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia
Symptomatic hypoglycemia
|
2 participants
|
3 participants
|
1 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: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo (One-Step Titration)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo (Combined)
Serious events: 5 serious events
Other events: 19 other events
Deaths: 0 deaths
Lixisenatide (Two-Step Titration)
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Lixisenatide (One-Step Titration)
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Lixisenatide (Combined)
Serious events: 1 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Two-Step Titration)
n=61 participants at risk
2-step initiation regimen of volume matching placebo.
|
Placebo (One-Step Titration)
n=61 participants at risk
1-step initiation regimen of volume matching placebo.
|
Placebo (Combined)
n=122 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=120 participants at risk
2-step initiation regimen of lixisenatide.
|
Lixisenatide (One-Step Titration)
n=119 participants at risk
1-step initiation regimen of lixisenatide.
|
Lixisenatide (Combined)
n=239 participants at risk
Included all patients who received 2-step initiation regimen of lixisenatide and 1-step initiation regimen of lixisenatide.
|
|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage III
|
1.6%
1/61 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, 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%
0/61 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.82%
1/122 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, 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%
0/120 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, 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%
0/119 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, 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%
0/239 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety 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%
0/61 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, 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%
0/61 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, 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%
0/122 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.83%
1/120 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, 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%
0/119 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.42%
1/239 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety 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
|
1.6%
1/61 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, 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%
0/61 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.82%
1/122 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, 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%
0/120 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, 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%
0/119 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, 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%
0/239 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety 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
Ileus
|
1.6%
1/61 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, 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%
0/61 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.82%
1/122 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, 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%
0/120 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, 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%
0/119 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, 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%
0/239 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety 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 glucose increased
|
0.00%
0/61 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety 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%
1/61 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.82%
1/122 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, 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%
0/120 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, 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%
0/119 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, 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%
0/239 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety 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
Ulna fracture
|
0.00%
0/61 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety 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%
1/61 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
0.82%
1/122 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, 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%
0/120 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, 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%
0/119 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, 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%
0/239 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety 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=61 participants at risk
2-step initiation regimen of volume matching placebo.
|
Placebo (One-Step Titration)
n=61 participants at risk
1-step initiation regimen of volume matching placebo.
|
Placebo (Combined)
n=122 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=120 participants at risk
2-step initiation regimen of lixisenatide.
|
Lixisenatide (One-Step Titration)
n=119 participants at risk
1-step initiation regimen of lixisenatide.
|
Lixisenatide (Combined)
n=239 participants at risk
Included all patients who received 2-step initiation regimen of lixisenatide and 1-step initiation regimen of lixisenatide.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
1.6%
1/61 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
3.3%
2/61 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety 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%
3/122 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety 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%
9/120 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety 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%
4/119 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
5.4%
13/239 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety 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
|
14.8%
9/61 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
8.2%
5/61 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
11.5%
14/122 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
8.3%
10/120 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
7.6%
9/119 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
7.9%
19/239 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety 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
|
4.9%
3/61 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
3.3%
2/61 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
4.1%
5/122 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
24.2%
29/120 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
20.2%
24/119 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
22.2%
53/239 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety 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%
0/61 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, 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%
0/61 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, 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%
0/122 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety 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%
9/120 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
6.7%
8/119 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
|
7.1%
17/239 • First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 85 days for all treatment arms.The analysis was performed on safety 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