| Primary | Change From Baseline to Day 56 in Plasma Glucose Corrected Area Under The Plasma Concentration-Time Curve (AUC) From Time 0.5 Hours to 4.5 Hours | Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 milligram per decilitre (mg/dL) with 1 mg/dL as limit of detection (LOD). Calculation of the AUC was made on Day -3 (baseline) and on Day 56 using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours]) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours). | Pharmacodynamic (PD) population defined as all randomized participants, who received at least one dose of lixisenatide 20 μg, liraglutide 1.2 mg or liraglutide 1.8 mg, and had both a baseline assessment and at least one post-baseline assessment of any primary or secondary PD variables, irrespective of compliance with study protocol and procedures. | Posted | | Least Squares Mean | Standard Error | h*mmol/L | | 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 56 | | | | ID | Title | Description |
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| OG000 | Lixisenatide 20 μg | Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin. | | OG001 | Liraglutide 1.2 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin. | | OG002 | Liraglutide 1.8 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-13.33± 1.11
- OG001-7.32± 1.12
- OG002-8.72± 1.16
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Analysis was performed using linear fixed effects model with treatment groups and stratification factors (HbA1c levels on Day -7 [<8% and >=8%], use of metformin at screening [yes or no]) and the study site) as fixed effects and baseline plasma glucose AUC from 0.5 to 4.5 hours as covariate. To address multiplicity issue and ensure overall 1-sided level of 5%, Hochberg method was used for testing procedure of comparison between lixisenatide vs liraglutide 1.2 mg or 1.8 mg. | Linear fixed effects model | The threshold for significance at 0.05 level. | <0.0001 | p-values ordered(p1≤p2) as per rules:if p2≤0.05: lixisenatide superior to liraglutide (both doses);if p2>0.05 & p1≤0.025:lixisenatide superior to dose of liraglutide associated with p1;if p2>0.05 & p1>0.025:no comparison as statistically significant. | Least squares (LS) mean difference | -6.01 | Standard Error of the Mean | 1.06 | 1-Sided | 95 | -7.77 |
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| Secondary | Change From Baseline to Day 56 in Plasma Glucose Corrected AUC From Time 0.5 Hours to 5.5 Hours | Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as limit of detection (LOD). Calculation of the AUC was made on Day -3 (baseline) and on Day 56 using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours]) to 5 hours after breakfast start (time: 5.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours). | PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points. | Posted | | Least Squares Mean | Standard Error | h*mmol/L | | 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56 | | | | ID | Title | Description |
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| OG000 | Lixisenatide 20 µg | Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin. | | OG001 | Liraglutide 1.2 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin. | |
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| Secondary | Number of Participants With 2-Hour Post-prandial Plasma Glucose (PPG) <7.77 (mmol/L) at Day 56 | Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. The 2-hour PPG test measured blood glucose 2 hours after start of a standardised breakfast. | PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points. | Posted | | Number | | participants | | Day 56 | | | | ID | Title | Description |
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| OG000 | Lixisenatide 20 µg | Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin. | | OG001 | Liraglutide 1.2 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin. | | OG002 | Liraglutide 1.8 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin. |
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| Secondary | Change From Baseline to Day 56 in PPG Excursion | Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. PPG excursion was determined on Day -3 (Baseline) and Day 56 as the maximum change in PPG from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration. | PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points. | Posted | | Least Squares Mean | Standard Error | mmol/L | | 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56 | | | | ID | Title | Description |
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| OG000 | Lixisenatide 20 µg | Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin. | | OG001 | Liraglutide 1.2 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin. | | OG002 | Liraglutide 1.8 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin. |
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| Secondary | Change From Baseline to Day 56 in Fasting Plasma Glucose (FPG) | Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. The value of FPG on Day -3 was the baseline. | PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points. | Posted | | Least Squares Mean | Standard Error | mmol/L | | 0.5 hour (prior to standardized breakfast) on Day -3; 0.5 hour (prior to standardized breakfast) on Day 56 | | | | ID | Title | Description |
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| OG000 | Lixisenatide 20 µg | Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin. | | OG001 | Liraglutide 1.2 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin. | | OG002 | Liraglutide 1.8 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin. |
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| Secondary | Change From Baseline to Day 56 in Average 7-Point Self-Monitored Plasma Glucose (SMPG) | Seven-point SMPG (before breakfast, 2 hours post breakfast, before lunch, 2 hours post lunch, before dinner, 2 hours post dinner, and at bedtime) was measured using Freestyle Precision glucometer and average of the 7 measurements was calculated. | PD population. Number of participants analyzed = participants with 7 point SMPG assessment at specified time-points. | Posted | | Mean | Standard Deviation | mmol/L | | Before breakfast, 2 hours post breakfast, before lunch, 2 hours post lunch, before dinner, 2 hours post dinner, and at bedtime on Day -3 (Baseline) and on Day 56 | | | | ID | Title | Description |
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| OG000 | Lixisenatide 20 µg | Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin. | | OG001 | Liraglutide 1.2 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin. | | OG002 | Liraglutide 1.8 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin. |
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| Secondary | Change From Baseline to Day 56 in Corrected C-Peptide AUC From Time 0.5 Hours to 5.5 Hours | C-peptide was assessed using the Electro Chemiluminescence Immuno Assay.The range of the method was 0.2 to 25 nanogram per millilitre (ng/mL) and the LOD was 0.07 ng/mL. Measurement was done on Day -3 (Baseline) and Day 56 as the maximum change in C-peptide from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration. | PD population. Number of participants analyzed = participants with C-peptide assessment at specified time-points. | Posted | | Least Squares Mean | Standard Error | h*nmol/L | | 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day-3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56 | | | | ID | Title | Description |
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| OG000 | Lixisenatide 20 µg | Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin. | | OG001 | Liraglutide 1.2 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin. | | OG002 | Liraglutide 1.8 mg |
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| Secondary | Change From Baseline to Day 56 in Corrected Glucagon AUC From Time 0.5 Hours to 5.5 Hours | Glucagon was assessed using the radioimmunoassay. The range of the method was 4.7 to 150 picomole per litre (pmol/L). Measurement was done on Day -3 (Baseline) and Day 56 as the maximum change in glucagon from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration. | PD population. Number of participants analyzed = participants with glucagon assessment at specified time-points. | Posted | | Least Squares Mean | Standard Error | h*ng/L | | 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56 | | | | ID | Title | Description |
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| OG000 | Lixisenatide 20 µg | Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin. | | OG001 | Liraglutide 1.2 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin. | | OG002 | Liraglutide 1.8 mg | |
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| Secondary | Change From Baseline to Day 56 in HbA1c | HbA1C was assessed using the high performance liquid chromatography method. | Number of participants analyzed = participants with HbA1c assessment at specified time-points. | Posted | | Least Squares Mean | Standard Error | percentage of HbA1c | | Pre-dose (Hour 0) on Day 1 (Baseline) and Day 56 | | | | ID | Title | Description |
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| OG000 | Lixisenatide 20 µg | Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin. | | OG001 | Liraglutide 1.2 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin. | | OG002 | Liraglutide 1.8 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin. |
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| Secondary | Change From Baseline to Day 56 in Average Daily Insulin Glargine Dose | | PD population. Number of participants analyzed=participants with insulin glargine dose assessment at specified time-points. | Posted | | Mean | Standard Deviation | units | | Day -7 (Baseline), Day 56 | | | | ID | Title | Description |
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| OG000 | Lixisenatide 20 µg | Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin. | | OG001 | Liraglutide 1.2 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin. | | OG002 | Liraglutide 1.8 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin. |
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| Secondary | Change From Baseline to Day 55 in Gastric Emptying Half Life (t1/2) | Gastric emptying was measured using 13C-octanoic acid breath test by isotope-selective non-dispersive infrared spectrometry. | PD population. Number of participants analyzed=participants with gastric emptying assessment at specified time-points. | Posted | | Least Squares Mean | Standard Error | minutes (min) | | 0 (prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55 | | | | ID | Title | Description |
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| OG000 | Lixisenatide 20 µg | Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin. | | OG001 | Liraglutide 1.2 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin. | | OG002 | Liraglutide 1.8 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin. |
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| Secondary | Change From Baseline to Day 55 in Gastric Emptying Coefficient | Gastric emptying was measured using 13C-octanoic acid breath test by isotope-selective non-dispersive infrared spectrometry. Gastric emptying coefficient was derived from a mathematical formula that describes the gastric emptying rate and gives an overall index of gastric emptying. | PD population. Number of participants analyzed = participants with gastric emptying at specified time-points. | Posted | | Mean | Standard Deviation | coefficient (unit-less) | | 0 (7:30 clock time, prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55 | | | | ID | Title | Description |
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| OG000 | Lixisenatide 20 µg | Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin. | | OG001 | Liraglutide 1.2 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin. | | OG002 | Liraglutide 1.8 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin. |
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| Secondary | Change From Baseline to Day 57/58 in 24-Hour Mean Heart Rate | The baseline value was the 24-hour mean on Day -2/-1 determined as overall, night and daytime mean. Measurements were made every 15 minutes from 07:00 to 23:00 (daytime) and every 30 minutes from 23:00 to 07:00 (night-time) at baseline and Day 57/58. Measurements were obtained after 10 minutes in the supine resting position. | PD population. Number of participants analyzed = participants with heart rate assessment at specified time-points. | Posted | | Least Squares Mean | Standard Error | beats per minute | | Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/-1 (Baseline) and Day 57/58 | | | | ID | Title | Description |
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| OG000 | Lixisenatide 20 µg | Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin. | | OG001 | Liraglutide 1.2 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin. | | OG002 | Liraglutide 1.8 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin. |
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| Secondary | Change From Baseline to Day 57/58 in 24-Hour Mean Systolic Blood Pressure and Diastolic Blood Pressure | The baseline value was the 24-hour means on Day -2/-1 determined as overall, night and day-time mean. Measurements were made every 15 minutes from 07:00 to 23:00 (day-time) and every 30 minutes from 23:00 to 07:00 (night-time) at baseline and at Day 57/58. Measurements were obtained after 10 minutes in the supine resting position. | PD population. Number of participants analyzed = participants with blood pressure assessment at specified time-points. | Posted | | Mean | Standard Deviation | mmHg | | Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/ -1 (Baseline) and Day 57/58 | | | | ID | Title | Description |
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| OG000 | Lixisenatide 20 µg | Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin. | | OG001 | Liraglutide 1.2 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin. | | OG002 | Liraglutide 1.8 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin. |
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| Secondary | Change From Baseline to Day 57 in Body Weight | | PD population. Number of participants analyzed = participants with body weight assessment at specified time-points. | Posted | | Least Squares Mean | Standard Error | kg | | 0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to study drug administration on Day 57 | | | | ID | Title | Description |
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| OG000 | Lixisenatide 20 µg | Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin. | | OG001 | Liraglutide 1.2 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin. | | OG002 | Liraglutide 1.8 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin. |
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| Secondary | Change From Baseline to Day 57 in Waist Circumference | | PD population. Number of participants analyzed = participants with waist circumference assessment at specified time-points. | Posted | | Mean | Standard Deviation | cm | | 0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to IMP administration on Day 57 | | | | ID | Title | Description |
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| OG000 | Lixisenatide 20 µg | Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin. | | OG001 | Liraglutide 1.2 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin. | | OG002 | Liraglutide 1.8 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin. |
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| Secondary | Change From Baseline to Day 56 in the Cumulative Score Mean on the Appetite Perception Using a Visual Analogue Scale After Standardized Solid Breakfast | Visual Analogue Scale, 100 mm in length with words anchored at each end, expressing the most positive (100 mm) and the most negative rating (0 mm), was used to assess hunger, satiety, fullness and prospective food consumption. Responses were measured as distance from the left end of the line to the mark. Mean change from baseline was calculated for each parameter separately. | PD population. Number of participants analyzed=participants with appetite perception assessment at specified time-points. | Posted | | Mean | Standard Deviation | mm | | 0.5 (8:00 clock time, prior to standardized breakfast), 1.5, 2.5, 3.5, 4.5, 5.5 hours on Day -3; 0 (prior to standardized breakfast), 1.5, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56 | | | | ID | Title | Description |
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| OG000 | Lixisenatide 20 µg | Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin. | | OG001 | Liraglutide 1.2 mg | Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin. | | OG002 | Liraglutide 1.8 mg |
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