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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2007-005887-29 |
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The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, used in a 2-step dose titration regimen in monotherapy, over a period of 12 weeks of treatment.
The primary objective is to assess the effects of lixisenatide, in comparison to placebo, on glycemic control using a 2-step dose titration regimen in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 12.
Secondary objectives are to assess the effects of lixisenatide, in comparison to placebo, on glycemic control in terms of HbA1c reduction when it is used in a one-step dose titration regimen over a period of 12 weeks, body weight, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG) after a standardized meal, to assess the safety and tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.
This is a double-blind, randomized, placebo-controlled, 4-arm, unbalanced design, parallel group study with a two-step titration regimen or a one-step titration regimen. The study is double-blind with regard to active and placebo treatments; however neither the study drug volume nor the titration regimens (that is, two-step or one-step) are blinded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (Two-Step Titration) | Placebo Comparator | 2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12. |
|
| Placebo (One-Step Titration) | Placebo Comparator | 1-step initiation regimen of volume matching placebo: 10 mcg QD for 2 weeks, then 20 mcg QD up to Week 12. |
|
| Lixisenatide (Two-Step Titration) | Experimental | 2-step initiation regimen of lixisenatide: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12. |
|
| Lixisenatide (One-Step Titration) | Experimental | 1-step initiation regimen of lixisenatide: 10 mcg QD for 2 weeks, then 20 mcg QD up to Week 12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lixisenatide (AVE0010) | Drug | Self administered by subcutaneous injections once daily within the hour preceding breakfast. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | 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. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 12 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glucose Excursion at Week 12 | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-Aventis Administrative Office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22432104 | Result | Fonseca VA, Alvarado-Ruiz R, Raccah D, Boka G, Miossec P, Gerich JE; EFC6018 GetGoal-Mono Study Investigators. Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy: a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes (GetGoal-Mono). Diabetes Care. 2012 Jun;35(6):1225-31. doi: 10.2337/dc11-1935. Epub 2012 Mar 19. | |
| 38770818 |
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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.
The study was conducted at 61 centers (68 were initiated) in 12 countries between May 14, 2008 and December 14, 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Placebo (One-Step Titration) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Self administered by subcutaneous injections once daily within the hour preceding breakfast. |
|
| Pen auto-injector | Device |
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|
| Baseline, Week 12 |
| Change From Baseline in Body Weight at Week 12 | 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. | Baseline, Week 12 |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 | 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. | Baseline, Week 12 |
| Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 12 | 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. | Week 12 |
| Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 12 | 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. | Week 12 |
| Percentage of Patients Requiring Rescue Therapy During the Double-Blind Treatment Period | 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. | Baseline up to Week 12 |
| Baseline, Week 12 |
| Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 12 | 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. | Baseline, Week 12 |
| Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia | 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. | First dose of study drug up to 3 days after the last dose administration |
| Diegem |
| Belgium |
| Sanofi-Aventis Administrative Office | Mumbai | India |
| Sanofi-Aventis Administrative Office | Netanya | Israel |
| Sanofi-Aventis Administrative Office | Tokyo | Japan |
| Sanofi-Aventis Administrative Office | México | Mexico |
| Sanofi-Aventis Administrative Office | Warsaw | Poland |
| Sanofi-Aventis Administrative Office | Bucharest | Romania |
| Sanofi-Aventis Administrative Office | Moscow | Russia |
| Sanofi-Aventis Administrative Office | Seoul | South Korea |
| Sanofi-Aventis Administrative Office | Mégrine | Tunisia |
| Sanofi-Aventis Administrative Office | Kiev | Ukraine |
| Derived |
| Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2. |
1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12. |
| FG002 | 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. |
| FG003 | 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. |
| Treated/Safety Population |
|
| Modified Intent-to-Treat(mITT)Population |
|
| Subgroup for Standardized Meal Test |
|
| COMPLETED |
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| NOT COMPLETED |
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Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (Combined) | Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Glycosylated Hemoglobin (HbA1c) | Mean | Standard Deviation | percentage of hemoglobin |
| |||||||||||||||
| 2-Hour Postprandial Plasma Glucose (PPG) | The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Number of patients analyzed = 60, 59 and 65 for Placebo (Combined), Lixisenatide (Two-Step Titration) and Lixisenatide (One-Step Titration) treatment arms, respectively, as meal challenge test was performed at selected sites only. | Mean | Standard Deviation | mmol/L |
| ||||||||||||||
| Body Weight | Mean | Standard Deviation | kilogram (kg) |
| |||||||||||||||
| Fasting Plasma Glucose (FPG) | Mean | Standard Deviation | millimole per liter (mmol/L) |
| |||||||||||||||
| Glucose Excursion | Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the meal test, before study drug administration. Number of patients analyzed = 60, 59 and 65 for Placebo (Combined), Lixisenatide (Two-Step Titration) and Lixisenatide (One-Step Titration) treatment arms, respectively, as meal challenge test was performed at selected sites only. | Mean | Standard Deviation | mmol/L |
| ||||||||||||||
| Duration of Diabetes | Median | Full Range | years |
| |||||||||||||||
| Body Mass Index (BMI) | BMI was calculated by dividing body weight by the height squared. | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
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| 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 | Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | 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. | 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. | Posted | Least Squares Mean | Standard Error | percentage of hemoglobin | Baseline, Week 12 |
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| Secondary | Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 12 | 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. | 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. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 12 |
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| Secondary | Change From Baseline in Body Weight at Week 12 | 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. | 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. | Posted | Least Squares Mean | Standard Error | kilogram | Baseline, Week 12 |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 | 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. | 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. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 12 |
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| Secondary | Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 12 | 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. | mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period. | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 12 | 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. | mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period. | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Percentage of Patients Requiring Rescue Therapy During the Double-Blind Treatment Period | 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. | mITT population. | Posted | Number | percentage of participants | Baseline up to Week 12 |
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| Other Pre-specified | Change From Baseline in Glucose Excursion at Week 12 | 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. | 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. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 12 |
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| Other Pre-specified | Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 12 | 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. | mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period. | Posted | Number | percentage of participants | Baseline, Week 12 |
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| Other Pre-specified | Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia | 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. | Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered. | Posted | Number | participants | First dose of study drug up to 3 days after the last dose administration |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (Two-Step Titration) | 2-step initiation regimen of volume matching placebo. | 3 | 61 | 11 | 61 | ||
| EG001 | Placebo (One-Step Titration) | 1-step initiation regimen of volume matching placebo. | 2 | 61 | 8 | 61 | ||
| EG002 | Placebo (Combined) | Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo. | 5 | 122 | 19 | 122 | ||
| EG003 | Lixisenatide (Two-Step Titration) | 2-step initiation regimen of lixisenatide. | 1 | 120 | 35 | 120 | ||
| EG004 | Lixisenatide (One-Step Titration) | 1-step initiation regimen of lixisenatide. | 0 | 119 | 31 | 119 | ||
| EG005 | Lixisenatide (Combined) | Included all patients who received 2-step initiation regimen of lixisenatide and 1-step initiation regimen of lixisenatide. | 1 | 239 | 66 | 239 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colon cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Non-systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 12.1 | Non-systematic Assessment |
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| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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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 |
| D006943 | Hyperglycemia |
| 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 |
Not provided
Not provided
Not provided
| Male |
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| Race: Black |
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| Race: Asian/Oriental |
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| Race: Other |
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| Ethnicity: Hispanic |
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| Ethnicity: Non Hispanic |
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| No |
| Superiority or Other |
| To detect a difference of 0.5% in change in HbA1c at Week 12 between 1 lixisenatide arm and placebo (combined), 120 patients per group would provide a power of 90% assuming common standard deviation of 1.2% with 2-sided test at 5% significance level. Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (<8.0,>=8.0%), BMI (<30,>=30 kg/m^2), country as fixed effects, baseline HbA1c as covariate. | ANCOVA | <0.0001 | Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined). | LS mean difference | -0.66 | Standard Error of the Mean | 0.122 | 2-Sided | 95 | -0.903 | -0.423 | No | Superiority or Other |
1-step initiation regimen of lixisenatide. |
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| Units | Counts |
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| Participants |
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1-step initiation regimen of lixisenatide. |
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| Units | Counts |
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| Participants |
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| Lixisenatide (One-Step Titration) |
1-step initiation regimen of lixisenatide. |
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