Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017666-23 | EudraCT Number | ||
| U1111-1116-9040 | Other Identifier | UTN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to compare the pharmacodynamic effects of lixisenatide (AVE0010), in comparison to liraglutide, as an add-on treatment to metformin, over a period of 4 weeks of treatment.
The primary objective is to assess the effects of lixisenatide, in comparison to liraglutide, in reducing postprandial plasma glucose (PPG) assessed as area under the plasma glucose concentration curve (AUC) after a standardized breakfast at Week 4.
The secondary objectives are to assess the effects of lixisenatide on the maximum PPG excursion, and on the changes in insulin, pro-insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast, 24-hour profile of plasma glucose, glycosylated hemoglobin (HbA1c), satiety markers (obestatin, peptide YY [PYY3-36] and oxyntomodulin); and to assess the clinical and laboratory safety profile.
The duration of the study for each patient is up to 7 weeks including a screening period up to 2 weeks, a treatment period of 4 weeks (Day 1 to Day 28), and an end-of-study visit 7 +/- 2 days after last study drug administration.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lixisenatide | Experimental | 1-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 2 weeks, followed by 20 mcg QD for up to Week 4. |
|
| Liraglutide | Active Comparator | 2-step initiation regimen of liraglutide: 0.6 milligram (mg) QD subcutaneously for 1 week, followed by 1.2 mg QD for 1 week, then 1.8 mg QD up to Week 4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lixisenatide (AVE0010) | Drug | Self administered by subcutaneous injections once daily 30 minutes before breakfast. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Area Under the Plasma Glucose Concentration Curve From Time 0.5 Hours to 4.5 Hours (GLU-AUC0:30-4:30h) at Day 28 | The area under the plasma glucose concentration time curve (GLU-AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours). GLU-AUC0:30-4:30h on Day -1 was the baseline. Change in GLU-AUC0:30-4:30h = GLU-AUC0:30-4:30h on Day 28 minus GLU-AUC0:30-4:30h on Day -1. | 0.5 (8:00 clock time; prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Postprandial Plasma Glucose (PPG) Excursion at Day 28 | PPG excursion was determined on Day -1 (Baseline) and 28 as the maximum change in PPG from time of breakfast start (time: 0.5 hours) until 4 hours later subtracted from pre-meal plasma concentration. | 0.5 (8:00 clock time; prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 28 |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Investigational Site Number 276006 | Berlin | 14050 | Germany | |||
| Sanofi-Aventis Investigational Site Number 276004 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23368510 | Result | Kapitza C, Forst T, Coester HV, Poitiers F, Ruus P, Hincelin-Mery A. Pharmacodynamic characteristics of lixisenatide once daily versus liraglutide once daily in patients with type 2 diabetes insufficiently controlled on metformin. Diabetes Obes Metab. 2013 Jul;15(7):642-9. doi: 10.1111/dom.12076. Epub 2013 Feb 25. |
Not provided
Not provided
A total of 259 patients were screened of which 111 (42.9%) were screen failures. A total of 148 patients were randomized.
The study was conducted at 7 centers in Germany between August 03, 2010 and November 18, 2010.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lixisenatide | 1-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 4. |
| FG001 | Liraglutide |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pen auto-injector | Device |
|
|
| Liraglutide | Drug | Self administered by subcutaneous injections once daily 30 minutes before breakfast. |
|
| Pre-filled pen injector | Device |
|
|
| Metformin | Drug | Metformin to be continued at stable dose (1.5 gram per day) up to Week 4. |
|
| Change From Baseline in Pro-insulin AUC(0:30-4:30h) at Day 28 | The area under the pro-insulin concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast pro-insulin concentration (time: 0.5 hours). Pro-insulin AUC0:30-4:30h on Day -1 was the baseline. Change in pro-insulin AUC0:30-4:30h = pro-insulin AUC0:30-4:30h on Day 28 minus pro-insulin AUC0:30-4:30h on Day -1. | 0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28 |
| Change From Baseline in Insulin AUC(0:30-4:30h) at Day 28 | The area under the insulin concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast insulin concentration (time: 0.5 hours). Insulin AUC0:30-4:30h on Day -1 was the baseline. Change in insulin AUC0:30-4:30h = insulin AUC0:30-4:30h on Day 28 minus insulin AUC0:30-4:30h on Day -1. | 0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28 |
| Change From Baseline in C-Peptide AUC(0:30-4:30h) at Day 28 | The area under the C-peptide concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast C-peptide concentration (time: 0.5 hours). C-peptide AUC0:30-4:30h on Day -1 was the baseline. Change in C-peptide AUC0:30-4:30h = C-peptide AUC0:30-4:30h on Day 28 minus C-peptide AUC0:30-4:30h on Day -1. | 0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28 |
| Change From Baseline in Glucagon AUC(0:30-4:30h) at Day 28 | The area under the glucagon concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast glucagon concentration (time: 0.5 hours). Glucagon AUC0:30-4:30h on Day -1 was the baseline. Change in glucagon AUC0:30-4:30h = glucagon AUC0:30-4:30h on Day 28 minus glucagon AUC0:30-4:30h on Day -1. | 0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28 |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 | Change = HbA1c value at Day 29 (24 hours post-dose on Day 28) minus HbA1c value at baseline (pre-dose [Hour 0] on Day 1). | Pre-dose (Hour 0) on Day 1 and 29 (that is, 24 hours post-dose on Day 28) |
| Change From Time-matched Baseline in Peptide YY3-36 (PYY3-36) Concentration at Day 28 | Change was calculated by subtracting time-matched baseline value from Day 28 value. Baseline value was the Day -1 time-matched PYY-36 assessment. | 0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28 |
| Change From Time-matched Baseline in Obestatin Concentration at Day 28 | Change was calculated by subtracting time-matched baseline value from Day 28 value. Baseline value was the Day -1 time-matched obestatin assessment. | 0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28 |
| Percentages of Patients by Ranges of Oxyntomodulin Levels | Percentage of patients with oxyntomodulin level less than or equal to (<=) limit of detection (LOD), above limit of quantification (LOQ) and between LOD and LOQ were reported. The LOD and LOQ values for oxyntomodulin were 70 and 200 picogram per milliliter (pg/mL) respectively. | 0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28 |
| Kiel |
| 24105 |
| Germany |
| Sanofi-Aventis Investigational Site Number 276002 | Mainz | 55116 | Germany |
| Sanofi-Aventis Investigational Site Number 276003 | Mannheim | 68167 | Germany |
| Sanofi-Aventis Investigational Site Number 276005 | Mönchengladbach | 41061 | Germany |
| Sanofi-Aventis Investigational Site Number 276007 | München | 80636 | Germany |
| Sanofi-Aventis Investigational Site Number 276001 | Neuss | 41460 | Germany |
2-step initiation regimen of liraglutide: 0.6 milligram (mg) QD subcutaneously for 1 week, followed by 1.2 mg QD for 1 week, then 1.8 mg QD up to Week 4.
| Safety Population |
|
| Pharmacodynamic (PD) Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lixisenatide | 1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 4. |
| BG001 | Liraglutide | 2-step initiation regimen of liraglutide: 0.6 mg QD subcutaneously for 1 week, followed by 1.2 mg QD for 1 week, then 1.8 mg QD up to Week 4. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Area Under Plasma Glucose Concentration Curve From Time 0.5 Hours to 4.5 Hours (GLU-AUC0:30-4:30h) | The area under the plasma glucose concentration time curve (GLU-AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (8:00 clock time; prior to standardized breakfast [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). GLU-AUC0:30-4:30h on Day -1 was the baseline. PD population was evaluable for this baseline characteristic. | Mean | Standard Deviation | hour*milligram per deciliter (h*mg/dL) |
| ||||||||||||||
| Postprandial Plasma Glucose (PPG) Excursion | PPG excursion was determined on Day -1 (baseline) as the maximum change in PPG from time of breakfast start (8:00 clock time; prior to standardized breakfast [time: 0.5 hours]) until 4 hours later subtracted from pre-meal plasma concentration. PD population was evaluable for this baseline characteristic. | Mean | Standard Deviation | milligram per deciliter (mg/dL) |
| ||||||||||||||
| Pro-insulin AUC(0:30-4:30h) | The area under the pro-insulin concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (8:00 clock time; prior to standardized breakfast [time: 0.5 hours]) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast pro-insulin concentration (time: 0.5 hours). Pro-insulin AUC0:30-4:30h on Day -1 was the baseline. PD population was evaluable for this baseline characteristic. | Mean | Standard Deviation | hour*micro international unit/milliliter |
| ||||||||||||||
| Insulin AUC(0:30-4:30h) | The area under the insulin concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (8:00 clock time; prior to standardized breakfast [time: 0.5 hours]) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast insulin concentration (time: 0.5 hours). Insulin AUC0:30-4:30h on Day -1 was the baseline. PD population was evaluable for this baseline characteristic. | Mean | Standard Deviation | hour*micro international unit/milliliter |
| ||||||||||||||
| C-Peptide AUC(0:30-4:30h) | The area under the C-peptide concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (8:00 clock time; prior to standardized breakfast [time: 0.5 hours]) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast C-peptide concentration (time: 0.5 hours). C-peptide AUC0:30-4:30h on Day -1 was the baseline. PD population was evaluable for this baseline characteristic. | Mean | Standard Deviation | hour*nanogram per milliliter (h*ng/mL) |
| ||||||||||||||
| Glucagon AUC(0:30-4:30h) | The area under the glucagon concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (8:00 clock time; prior to standardized breakfast [time: 0.5 hours]) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast glucagon concentration (time: 0.5 hours). Glucagon AUC0:30-4:30h on Day -1 was the baseline. PD population was evaluable for this baseline characteristic. | Mean | Standard Deviation | hour*picogram per milliliter (h*pg/mL) |
| ||||||||||||||
| Glycosylated Hemoglobin (HbA1c) | HbA1c on Day 1 (pre-dose [hour 0]) was the baseline. Number of patients analyzed = 74 and 68 for Lixisenatide and Liraglutide arms, respectively. | Mean | Standard Deviation | percentage of hemoglobin |
| ||||||||||||||
| Peptide YY3-36 (PYY3-36) Concentration | PYY3-36 concentration was determined at 0.5 (8:00 clock time; prior to standardized breakfast), 2.5 and 4.5 hours on Day -1 (time-matched baseline). PD population was evaluable for this baseline characteristic. | Mean | Standard Deviation | picomole per liter (pmol/L) |
| ||||||||||||||
| Obestatin Concentration | Obestatin concentration was determined at 0.5 (8:00 clock time; prior to standardized breakfast), 2.5 and 4.5 hours on Day -1 (time-matched baseline). PD population was evaluable for this baseline characteristic. | Mean | Standard Deviation | nanomole per liter (nmol/L) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Area Under the Plasma Glucose Concentration Curve From Time 0.5 Hours to 4.5 Hours (GLU-AUC0:30-4:30h) at Day 28 | The area under the plasma glucose concentration time curve (GLU-AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours). GLU-AUC0:30-4:30h on Day -1 was the baseline. Change in GLU-AUC0:30-4:30h = GLU-AUC0:30-4:30h on Day 28 minus GLU-AUC0:30-4:30h on Day -1. | Pharmacodynamic (PD) population (modified intent-to-treat [mITT] population) included all randomized patients, who received at least 1 dose of lixisenatide or liraglutide, and had both a baseline assessment and at least 1 post-baseline assessment of any pharmacodynamic variable, irrespective of compliance with the study protocol and procedures. | Posted | Least Squares Mean | 95% Confidence Interval | h*mg/dL | 0.5 (8:00 clock time; prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 28 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Postprandial Plasma Glucose (PPG) Excursion at Day 28 | PPG excursion was determined on Day -1 (Baseline) and 28 as the maximum change in PPG from time of breakfast start (time: 0.5 hours) until 4 hours later subtracted from pre-meal plasma concentration. | PD population. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | 0.5 (8:00 clock time; prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pro-insulin AUC(0:30-4:30h) at Day 28 | The area under the pro-insulin concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast pro-insulin concentration (time: 0.5 hours). Pro-insulin AUC0:30-4:30h on Day -1 was the baseline. Change in pro-insulin AUC0:30-4:30h = pro-insulin AUC0:30-4:30h on Day 28 minus pro-insulin AUC0:30-4:30h on Day -1. | PD population. | Posted | Least Squares Mean | 95% Confidence Interval | hour*micro international unit/milliliter | 0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Insulin AUC(0:30-4:30h) at Day 28 | The area under the insulin concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast insulin concentration (time: 0.5 hours). Insulin AUC0:30-4:30h on Day -1 was the baseline. Change in insulin AUC0:30-4:30h = insulin AUC0:30-4:30h on Day 28 minus insulin AUC0:30-4:30h on Day -1. | PD population. | Posted | Least Squares Mean | 95% Confidence Interval | hour*micro international unit/milliliter | 0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in C-Peptide AUC(0:30-4:30h) at Day 28 | The area under the C-peptide concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast C-peptide concentration (time: 0.5 hours). C-peptide AUC0:30-4:30h on Day -1 was the baseline. Change in C-peptide AUC0:30-4:30h = C-peptide AUC0:30-4:30h on Day 28 minus C-peptide AUC0:30-4:30h on Day -1. | PD population. | Posted | Least Squares Mean | 95% Confidence Interval | h*ng/mL | 0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Glucagon AUC(0:30-4:30h) at Day 28 | The area under the glucagon concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast glucagon concentration (time: 0.5 hours). Glucagon AUC0:30-4:30h on Day -1 was the baseline. Change in glucagon AUC0:30-4:30h = glucagon AUC0:30-4:30h on Day 28 minus glucagon AUC0:30-4:30h on Day -1. | PD population. | Posted | Least Squares Mean | 95% Confidence Interval | h*pg/mL | 0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 | Change = HbA1c value at Day 29 (24 hours post-dose on Day 28) minus HbA1c value at baseline (pre-dose [Hour 0] on Day 1). | PD population. Here, number of patients analyzed = patients with post-baseline HbA1c assessment. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of hemoglobin | Pre-dose (Hour 0) on Day 1 and 29 (that is, 24 hours post-dose on Day 28) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Time-matched Baseline in Peptide YY3-36 (PYY3-36) Concentration at Day 28 | Change was calculated by subtracting time-matched baseline value from Day 28 value. Baseline value was the Day -1 time-matched PYY-36 assessment. | PD population. | Posted | Mean | Standard Deviation | pmol/L | 0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Time-matched Baseline in Obestatin Concentration at Day 28 | Change was calculated by subtracting time-matched baseline value from Day 28 value. Baseline value was the Day -1 time-matched obestatin assessment. | PD population. | Posted | Mean | Standard Deviation | nmol/L | 0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentages of Patients by Ranges of Oxyntomodulin Levels | Percentage of patients with oxyntomodulin level less than or equal to (<=) limit of detection (LOD), above limit of quantification (LOQ) and between LOD and LOQ were reported. The LOD and LOQ values for oxyntomodulin were 70 and 200 picogram per milliliter (pg/mL) respectively. | PD population. Here, 'n' signifies patients with oxyntomodulin assessment at the specified time point. | Posted | Number | percentage of participants | 0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28 |
|
|
First dose of study drug up to 3 days after the last dose administration, up to 31 days
Median exposure to study treatment was 28 days in both 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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lixisenatide | 1-step initiation regimen of lixisenatide. | 0 | 77 | 36 | 77 | ||
| EG001 | Liraglutide | 2-step initiation regimen of liraglutide. | 0 | 71 | 47 | 71 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
Data for "Percentages of patients by ranges of oxyntomodulin levels" was reported instead of "Change from Baseline in oxyntomodulin concentration at Day 28" due to change in planned analysis as there were high numbers of values below the LOD.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact-us@sanofi.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C479460 | lixisenatide |
| D000069450 | Liraglutide |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| Black |
|
| 2.5 h |
|
| 4.5 h |
|
| 2.5 h |
|
| 4.5 h |
|
| Superiority or Other |
|
|
|
|
|
|
|
|
|
|
|