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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1116-8938 | Other Identifier | UTN |
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The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010) in comparison to placebo, as an add-on treatment to metformin with or without sulfonylurea, over a period of 24 weeks of treatment.
The primary objective is to assess the effects on glycemic control of lixisenatide (AVE0010) in comparison to placebo as an add-on treatment to metformin with or without sulfonylurea in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.
The secondary objectives are to assess the effects of lixisenatide over 24 weeks on percentage of patients reaching HbA1c less than (< ) 7 percent (%) or HbA1c less than or equal to (<=) 6.5%, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG) and glucose excursion during standardized meal test, body weight; to evaluate safety, tolerability, pharmacokinetic (PK) and anti-lixisenatide antibody development.
The study duration for each patient is 27 weeks +/- 10 days (up to 2 weeks screening + 1 week run-in + 24 weeks double-blind treatment + 3 days follow-up).
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| 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 up to Week 24. |
|
| Placebo | Placebo Comparator | 1-step initiation regimen of volume matching placebo: 10 mcg QD for 2 weeks, followed by 20 mcg QD up to Week 24. |
|
| 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 24 | Absolute change = HbA1c value at Week 24 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 on-treatment assessment for at least 1 efficacy variable, were required. | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Change was calculated by subtracting Baseline value from Week 24 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 on-treatment assessment for at least 1 efficacy variable, were required. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24 | 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 on-treatment assessment for at least 1 efficacy variable, were required. |
Inclusion criteria:
- Type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit, insufficiently controlled with metformin alone or metformin with sulfonylurea at the time of the screening visit
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 156011 | Beijing | 100034 | China | |||
| Investigational Site Number 156012 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24639432 | Result | Yu Pan C, Han P, Liu X, Yan S, Feng P, Zhou Z, Lv X, Tian H, Jin Kui Y, Su B, Shang S, Niemoeller E. Lixisenatide treatment improves glycaemic control in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin with or without sulfonylurea: a randomized, double-blind, placebo-controlled, 24-week trial (GetGoal-M-Asia). Diabetes Metab Res Rev. 2014 Nov;30(8):726-35. doi: 10.1002/dmrr.2541. | |
| 27252787 |
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A total of 655 patients were screened of which 264 (40.3%) 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 391 patients were randomized.
The study was conducted at 35 centers in 4 countries between July 21, 2010 and December 22, 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 1-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24. |
| FG001 | Lixisenatide |
| 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 |
|
|
| Metformin | Drug | Metformin to be continued at stable dose (at least 1.0 gram per day and not more than 1.5 gram per day) up to Week 24. |
|
| Sulfonylurea | Drug | Sulfonylurea if given at screening, to be continued up to Week 24. In patients with a screening HbA1c <8% the dose is decreased by 25% to 50% at randomization and then increased up to the screening dose between Week 4 and 12 as per fasting self-monitored plasma glucose (SMPG) values. In patients with a screening HbA1c >=8%, the dose is not to be changed at randomization. In any case, after Week 12, sulfonylurea is to be continued at a stable dose. |
|
| Baseline, Week 24 |
| Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24 | The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting Baseline value from Week 24 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. | Baseline, Week 24 |
| Change From Baseline in Body Weight at Week 24 | Change was calculated by subtracting Baseline value from Week 24 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 on-treatment assessment for at least 1 efficacy variable, were required. | Baseline, Week 24 |
| Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24 | 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 on-treatment assessment for at least 1 efficacy variable, were required. | Week 24 |
| Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24 | 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 on-treatment assessment for at least 1 efficacy variable, were required. | Week 24 |
| Change From Baseline in Glucose Excursion at Week 24 | Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting Baseline value from Week 24 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. | Baseline, Week 24 |
| Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period | Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >250 milligram/deciliter (mg/dL) (13.9 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >220 mg/dL (12.2 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required. | Baseline up to Week 24 |
| Baseline, Week 24 |
| 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 |
| Beijing |
| 100101 |
| China |
| Investigational Site Number 156019 | Beijing | 100191 | China |
| Investigational Site Number 156002 | Beijing | 100700 | China |
| Investigational Site Number 156003 | Beijing | 100730 | China |
| Investigational Site Number 156009 | Beijing | 100730 | China |
| Investigational Site Number 156001 | Beijing | 100853 | China |
| Investigational Site Number 156036 | Changchun | 130041 | China |
| Investigational Site Number 156016 | Changsha | 410008 | China |
| Investigational Site Number 156015 | Changsha | 410011 | China |
| Investigational Site Number 156006 | Chengdu | 610041 | China |
| Investigational Site Number 156032 | Chengdu | 610072 | China |
| Investigational Site Number 156010 | Dalian | 116027 | China |
| Investigational Site Number 156004 | Guangzhou | 510080 | China |
| Investigational Site Number 156008 | Guangzhou | 510080 | China |
| Investigational Site Number 156025 | Guangzhou | 510630 | China |
| Investigational Site Number 156031 | Haikou | 57028 | China |
| Investigational Site Number 156014 | Harbin | 150001 | China |
| Investigational Site Number 156029 | Hefei | 230022 | China |
| Investigational Site Number 156013 | Qingdao | 266003 | China |
| Investigational Site Number 156007 | Shanghai | 200003 | China |
| Investigational Site Number 156030 | Shanghai | 200065 | China |
| Investigational Site Number 156020 | Shenyang | 110004 | China |
| Investigational Site Number 156035 | Suzhou | 215004 | China |
| Investigational Site Number 156033 | Taiyuan | 030001 | China |
| Investigational Site Number 156037 | Tianjin | 300052 | China |
| Investigational Site Number 156022 | Xi'an | 710032 | China |
| Investigational Site Number 156023 | Xi'an | 710061 | China |
| Investigational Site Number 344001 | Hong Kong | Hong Kong |
| Investigational Site Number 344003 | Hong Kong | Hong Kong |
| Investigational Site Number 344002 | Shatin, Nt | Hong Kong |
| Investigational Site Number 458001 | Kelantan | 16150 | Malaysia |
| Investigational Site Number 458003 | Kuala Lumpur | 59100 | Malaysia |
| Investigational Site Number 458002 | Putrajaya | 62250 | Malaysia |
| Investigational Site Number 764002 | Bangkok | 10400 | Thailand |
| Derived |
| Seino H, Onishi Y, Naito Y, Komatsu M. Lixisenatide improves glycemic outcomes of Japanese patients with type 2 diabetes: a meta-analysis. Diabetol Metab Syndr. 2016 Jun 1;8:36. doi: 10.1186/s13098-016-0151-7. eCollection 2016. |
1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
| Treated/Safety Population |
|
| Modified Intent-to-Treat(mITT)Population |
|
| Subgroup for Standardized Meal Test |
|
| 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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24. |
| BG001 | Lixisenatide | 1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24. |
| 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 |
| ||||||||||||||||
| Glycosylated Hemoglobin (HbA1c) | Mean | Standard Deviation | percentage of hemoglobin |
| |||||||||||||||
| Fasting Plasma Glucose (FPG) | Mean | Standard Deviation | millimole per liter (mmol/L) |
| |||||||||||||||
| 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 = 130 and 121 for Placebo and Lixisenatide treatment arm, respectively, as meal challenge test was performed at selected sites only. | Mean | Standard Deviation | 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 = 130 and 121 for Placebo and Lixisenatide treatment arm, respectively, as meal challenge test was performed at selected sites only. | Mean | Standard Deviation | mmol/L |
| ||||||||||||||
| Body Weight | Mean | Standard Deviation | kilogram (kg) |
| |||||||||||||||
| Duration of Diabetes | Mean | Standard Deviation | 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) |
| ||||||||||||||
| Metformin Daily Dose | Mean | Standard Deviation | milligram (mg) per day |
| |||||||||||||||
| Number of Patients With Sulfonylurea use at Baseline | Number | participants |
|
| 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 24 | Absolute change = HbA1c value at Week 24 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 on-treatment 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 24 |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Change was calculated by subtracting Baseline value from Week 24 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 on-treatment assessment for at least 1 efficacy variable, were required. | mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 24 |
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| Secondary | Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24 | The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting Baseline value from Week 24 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. | 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 2-hour PPG assessment during on-treatment period. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 24 |
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| Secondary | Change From Baseline in Body Weight at Week 24 | Change was calculated by subtracting Baseline value from Week 24 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 on-treatment 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 24 |
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| Secondary | Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24 | 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 on-treatment 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 24 |
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| Secondary | Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24 | 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 on-treatment 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 24 |
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| Secondary | Change From Baseline in Glucose Excursion at Week 24 | Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting Baseline value from Week 24 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. | 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 24 |
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| Other Pre-specified | Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24 | 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 on-treatment 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 24 |
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| Secondary | Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period | Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >250 milligram/deciliter (mg/dL) (13.9 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >220 mg/dL (12.2 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required. | mITT population. | Posted | Number | percentage of participants | Baseline up to Week 24 |
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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 |
|
First dose of study drug up to 3 days after the last dose administration
Median exposure to study treatment was 169 days for 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 | Placebo | 1-step initiation regimen of volume matching placebo. | 4 | 194 | 46 | 194 | ||
| EG001 | Lixisenatide | 1-step initiation regimen of lixisenatide. | 3 | 196 | 80 | 196 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylactic shock | Immune system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment | Hypoglycaemia adverse event is based on investigator reported hypoglycaemia. |
|
| Dizziness | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Diabetic nephropathy | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
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 |
| D008687 | Metformin |
| D013453 | Sulfonylurea Compounds |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D014508 | Urea |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
Not provided
Not provided
| Male |
|
| No |
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| Units |
|---|
| Counts |
|---|
| Participants |
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