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The purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) used as 2-step initiation regimen and 1-step initiation regimen in Japan, over a period of 24 weeks of treatment, followed by an extension up to Week 76.
The primary objective of this study is to evaluate the safety of lixisenatide once daily treatment in monotherapy at Week 24 by a descriptive comparison of a 1-step initiation and a 2-step initiation regimen in patients with type 2 diabetes in Japan.
The secondary objectives are to assess the overall safety of lixisenatide once daily treatment in monotherapy at Week 52 and Week 76; to assess the effects of lixisenatide on glycosylated hemoglobin (HbA1c) reduction at Week 52 and Week 76, body weight, and fasting plasma glucose (FPG); to assess pharmacokinetics (PK) and anti-lixisenatide antibody development.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lixisenatide (Two-step Titration) | Experimental | 2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment. |
|
| Lixisenatide (One-step Titration) | Experimental | 1-step initiation regimen of lixisenatide: 10 mcg QD for 2 weeks, then 20 mcg QD up to end of treatment. |
|
| 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 |
|---|---|---|
| Overview of Adverse Event Profile (Treatment Emergent Adverse Events) of the One-Step and Two-Step Titration Arms Assessed Through Adverse Events Collection and Vital Signs, Electrocardiogram (ECG) and Laboratory Monitoring | Overview of adverse event profile is reported in terms of percentage of patients with treatment emergent adverse events (TEAEs) during the 24-week treatment period: any TEAE; any serious TEAE; any TEAE leading to death; and any TEAE leading to permanent treatment discontinuation. | First dose of study drug up to 3 days after the last dose of study drug at Week 24 or early withdrawal |
| Measure | Description | Time Frame |
|---|---|---|
| Overview of Adverse Event Profile (Treatment Emergent Adverse Events) of All Patients During On-Treatment Period Assessed Through Adverse Events Collection and Vital Signs, ECG and Laboratory Monitoring | Overview of adverse event profile is reported in terms of percentage of patients with TEAEs during the on-treatment period: any TEAE; any serious TEAE; any TEAE leading to death; any TEAE leading to permanent treatment discontinuation. The on-treatment period was the time from the first dose of study drug up to 3 days after the last dose at Week 76. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Requiring Rescue Therapy | 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 Week 4 to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%, from Week 24 to end of treatment (Week 76): fasting SMPG/FPG >180 mg/dL (10.0 mmol/L) or HbA1c >8%. 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 | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26342556 | Result | Seino Y, Yabe D, Takami A, Niemoeller E, Takagi H. Long-term safety of once-daily lixisenatide in Japanese patients with type 2 diabetes mellitus: GetGoal-Mono-Japan. J Diabetes Complications. 2015 Nov-Dec;29(8):1304-9. doi: 10.1016/j.jdiacomp.2015.07.003. Epub 2015 Jul 6. |
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A total of 75 patients were screened of which 6(8.0%) were screen failures; main reasons for screen failure:glycosylated hemoglobin being out of defined protocol range (>=7% and <=10%) and use of an antidiabetic agent other than a sulfonylurea or alpha-glucosidase inhibitor within 3 months prior to screening. A total of 69 patients were randomized.
The study was conducted at 9 centers in Japan between May 09, 2009 and January 22, 2011. The overall duration of treatment was at least 76 weeks (52-week open-label treatment; 24-week open-label extension treatment).
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| ID | Title | Description |
|---|---|---|
| FG000 | Lixisenatide (Two-step Titration) | 2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment. |
| FG001 | Lixisenatide (One-step Titration) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Pen auto-injector | Device |
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| First dose of study drug up to 3 days after the last dose of study drug at Week 76 or early withdrawal |
| Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) for All Patients at Week 52 and 76 | Absolute change = HbA1c value at week of assessment (Week 52/Week 76) 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 52, 76 |
| Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 52 and 76 | 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 52, 76 |
| Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 52 and 76 | 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 52, 76 |
| Change From Baseline in Body Weight for All Patients at Week 52 and 76 | Change was calculated by subtracting baseline value from value at week of assessment (Week 52/Week 76). 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 52, 76 |
| Change From Baseline in Fasting Plasma Glucose (FPG) for All Patients at Week 52 and 76 | Change was calculated by subtracting baseline value from value at week of assessment (Week 52/Week 76). 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 52, 76 |
| Baseline up to Week 52, Baseline up to Week 76 |
| Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia for the One-Step and Two-Step Titration Arms During 24-Week Treatment Period | 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 less than 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 of study drug at Week 24 or early withdrawal |
| Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia for All Patients During On-Treatment Period | 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 less than 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.The on-treatment period was the time from the first dose of study drug up to 3 days after the last dose. | First dose of study drug up to 3 days after the last dose of study drug at Week 76 or early withdrawal |
1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to end of treatment. |
| Safety Population |
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| Modified Intent-to-Treat(mITT)Population |
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| 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 | 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 end of treatment. |
| BG001 | Lixisenatide (One-step Titration) | 1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to end of treatment. |
| 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 |
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| Gender | 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) |
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| Body Weight | Mean | Standard Deviation | kilogram (kg) |
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| 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) |
| ||||||||||||||
| Duration of Diabetes | Duration of diabetes is reported at screening. | Mean | Standard Deviation | years |
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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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Overview of Adverse Event Profile (Treatment Emergent Adverse Events) of All Patients During On-Treatment Period Assessed Through Adverse Events Collection and Vital Signs, ECG and Laboratory Monitoring | Overview of adverse event profile is reported in terms of percentage of patients with TEAEs during the on-treatment period: any TEAE; any serious TEAE; any TEAE leading to death; any TEAE leading to permanent treatment discontinuation. The on-treatment period was the time from the first dose of study drug up to 3 days after the last dose at Week 76. | Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified | Posted | Number | percentage of participants | First dose of study drug up to 3 days after the last dose of study drug at Week 76 or early withdrawal |
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| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Patients Requiring Rescue Therapy | 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 Week 4 to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%, from Week 24 to end of treatment (Week 76): fasting SMPG/FPG >180 mg/dL (10.0 mmol/L) or HbA1c >8%. 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.Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified | Posted | Number | percentage of participants | Baseline up to Week 52, Baseline up to Week 76 |
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| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia for the One-Step and Two-Step Titration Arms During 24-Week Treatment Period | 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 less than 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 of study drug at Week 24 or early withdrawal |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) for All Patients at Week 52 and 76 | Absolute change = HbA1c value at week of assessment (Week 52/Week 76) 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. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period and "n" = patients with HbA1c assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified | Posted | Mean | Standard Deviation | percentage of hemoglobin | Baseline, Week 52, 76 |
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| Secondary | Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 52 and 76 | 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. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period and "n" = patients with HbA1c assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified | Posted | Number | percentage of participants | Week 52, 76 |
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| Secondary | Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 52 and 76 | 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. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period and "n" = patients with HbA1c assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified | Posted | Number | percentage of participants | Week 52, 76 |
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| Primary | Overview of Adverse Event Profile (Treatment Emergent Adverse Events) of the One-Step and Two-Step Titration Arms Assessed Through Adverse Events Collection and Vital Signs, Electrocardiogram (ECG) and Laboratory Monitoring | Overview of adverse event profile is reported in terms of percentage of patients with treatment emergent adverse events (TEAEs) during the 24-week treatment period: any TEAE; any serious TEAE; any TEAE leading to death; and any TEAE leading to permanent treatment discontinuation. | 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 | percentage of participants | First dose of study drug up to 3 days after the last dose of study drug at Week 24 or early withdrawal |
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| Secondary | Change From Baseline in Body Weight for All Patients at Week 52 and 76 | Change was calculated by subtracting baseline value from value at week of assessment (Week 52/Week 76). 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. Number of patients analyzed=patients with baseline and at least 1 post-baseline weight assessment during on-treatment period and "n" = patients with weight assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified | Posted | Mean | Standard Deviation | kilogram | Baseline, Week 52, 76 |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) for All Patients at Week 52 and 76 | Change was calculated by subtracting baseline value from value at week of assessment (Week 52/Week 76). 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. Number of patients analyzed=patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period and "n" = patients with FPG assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 52, 76 |
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| Other Pre-specified | Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia for All Patients During On-Treatment Period | 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 less than 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.The on-treatment period was the time from the first dose of study drug up to 3 days after the last dose. | Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified | Posted | Number | participants | First dose of study drug up to 3 days after the last dose of study drug at Week 76 or early withdrawal |
|
First dose of study drug up to 3 days after the last dose administration up to week 76
Median exposure to study treatment was 531 and 533 days in lixisenatide two-step titration and lixisenatide one-step titration arms, respectively. 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 | Lixisenatide (Two-step Titration) | 2-step initiation regimen of lixisenatide. | 2 | 33 | 24 | 33 | ||
| EG001 | Lixisenatide (One-step Titration) | 1-step initiation regimen of lixisenatide. | 1 | 36 | 34 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment | Hypoglycaemia adverse event is based on investigator reported hypoglycaemia. |
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| Headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Diabetic retinopathy | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Yawning | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Early satiety | General disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.1 | 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 |
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| ID | Term |
|---|---|
| C479460 | lixisenatide |
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| Male |
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| Ethnicity: Non Hispanic |
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| Title | Measurements |
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| Any TEAE Leading to Treatment Discontinuation |
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| Units | Counts |
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| Units | Counts |
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| Participants |
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