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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002416-85 | EudraCT Number | ||
| U1111-1118-0841 | Other Identifier | UTN |
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Primary Objective:
- To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24)
Secondary Objective:
To assess the effect of the 2 lixisenatide regimens on:
To assess the safety and tolerability of the 2 lixisenatide regimens
The maximum study duration was 28 weeks per participant, including a 24-week randomized treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lixisenatide Main Meal | Experimental | Lixisenatide 10 mcg once daily (QD) within 1 hour before "main meal of the day" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24. |
|
| Lixisenatide Breakfast | Active Comparator | Lixisenatide 10 mcg QD within 1 hour before "breakfast" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lixisenatide (AVE0010) | Drug | Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c From Baseline to Week 24 | Change in HbA1C was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period. | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HbA1c Level <7 % or ≤6.5% at Week 24 | Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period. | Week 24 |
| Change in Average 7-point SMPG Profiles From Baseline to Week 24 |
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Inclusion criteria:
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 840112 | Glendale | Arizona | 85306 | United States | ||
| Investigational Site Number 840113 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25012990 | Result | Ahren B, Vorokhobina N, Souhami E, Demil N, Ye J, Aronson R. Equal improvement in glycaemia with lixisenatide given before breakfast or the main meal of the day. J Diabetes Complications. 2014 Sep-Oct;28(5):735-41. doi: 10.1016/j.jdiacomp.2014.05.012. Epub 2014 Jun 5. |
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Participants were stratified according to main meal of day (breakfast, lunch or dinner) and screening values of HbA1c (<8% or ≥8%).
The study was conducted at 82 centers in 10 countries. A total of 734 participants were screened between February 15, 2012 and October 16, 2012. 283 participants were screen failures; main reason for screen failure was that glycosylated hemoglobin (HbA1c) values were out of protocol defined range. 451 participants were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lixisenatide Main Meal | Lixisenatide 10 mcg subcutaneous (SC) injection once daily (QD) within 1 hour before "main meal of the day" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin. |
| FG001 | Lixisenatide Breakfast |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Self-injector pen device (OptiClik®) | Device |
|
| Metformin | Drug | To be kept at stable dose (≥1.5 g/day) throughout the study. |
|
|
Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime two times in a week before baseline, before visit Week 8, before visit Week 12 and before visit week 24. The average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period. |
| Baseline, Week 24 |
| Change in FPG From Baseline to Week 24 | Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment during on-treatment period. | Baseline, Week 24 |
| Change in Body Weight From Baseline to Week 24 | Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period. | Baseline, Week 24 |
| Percentage of Participants Who Reached the Target of HbA1c <7% at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (Plasma Glucose [PG] <60 mg/dL [3.3 mmol/L]) During 24-Week Treatment Period | Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemic episode with an accompanying PG<60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate if no PG measurement was available. On-treatment period for symptomatic hypoglycemia assessment was defined as time from first dose of study drug up to 1 day after last dose of study drug. Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one symptomatic hypoglycemia. Otherwise, they were counted as missing. | Week 24 |
| Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24 | Participants without post-baseline on-treatment values for (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing. | Week 24 |
| Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (PG<60 mg/dL [3.3 mmol/L]) During the 24-Week Treatment Period | Participants without post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart not more than 30-days apart were counted as non-responders if at least one of components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing. | Week 24 |
| Percentage of Participants Who Reached the Target of HbA1c <7% And Had a 2-hour Postprandial Plasma Glucose (PPG) <140mg/dL After Breakfast or Main Meal At Week 24 | On-treatment period for 2-hour PPG assessment was defined as the time from the first dose of study drug up to the day of last dose of study drug. Participants without post-baseline on-treatment values (for HbA1c and 2-hour PPG) that were no more than 30-days apart were counted as non-responders if at least one of the components (HbA1cand/or 2-hour PPG) was available and showed no response. Otherwise, they were counted as missing. | Week 24 |
| Change in Diabetes Treatment Satisfaction Questionnaire Score (DTSQs) From Baseline to Week 24 | DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1, 4, 5, 6, 7 and 8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. On-treatment period for treatment satisfaction assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Missing data was imputed using LOCF. Here, number of participants analyzed = participants with both baseline and Week 24 DTSQ score assessment during on-treatment period. | Baseline, Week 24 |
| Mesa |
| Arizona |
| 85213 |
| United States |
| Investigational Site Number 840105 | Phoenix | Arizona | 85028 | United States |
| Investigational Site Number 840102 | Tempe | Arizona | 85282 | United States |
| Investigational Site Number 840107 | Tempe | Arizona | United States |
| Investigational Site Number 840116 | Mission Viejo | California | 92691 | United States |
| Investigational Site Number 840103 | Northridge | California | 91325 | United States |
| Investigational Site Number 840118 | Redlands | California | 92374 | United States |
| Investigational Site Number 840104 | Temecula | California | 92591 | United States |
| Investigational Site Number 840122 | Chicago | Illinois | 60611 | United States |
| Investigational Site Number 840119 | Chicago | Illinois | 60616 | United States |
| Investigational Site Number 840114 | Springfield | Illinois | 62704 | United States |
| Investigational Site Number 840120 | Flint | Michigan | 48504 | United States |
| Investigational Site Number 840115 | Billings | Montana | 59103 | United States |
| Investigational Site Number 840101 | Sea Girt | New Jersey | 08750 | United States |
| Investigational Site Number 840111 | Fargo | North Dakota | 58103 | United States |
| Investigational Site Number 840110 | West Jordan | Utah | 84088 | United States |
| Investigational Site Number 124102 | Brampton | L6R 3J5 | Canada |
| Investigational Site Number 124108 | Coquitlam | V3K 3P4 | Canada |
| Investigational Site Number 124106 | Etobicoke | M9R 4E1 | Canada |
| Investigational Site Number 124113 | Kelowna | V1Y 1Z9 | Canada |
| Investigational Site Number 124110 | Laval | H7T 2P5 | Canada |
| Investigational Site Number 124103 | Newmarket | L3Y 5G8 | Canada |
| Investigational Site Number 124101 | Oakville | L6H 3P1 | Canada |
| Investigational Site Number 124111 | Saint Romuald | G6W 5M6 | Canada |
| Investigational Site Number 124104 | Thornhill | L4J 8L7 | Canada |
| Investigational Site Number 124105 | Toronto | M9V 4B4 | Canada |
| Investigational Site Number 124112 | Vancouver | V5Z 1M9 | Canada |
| Investigational Site Number 203104 | Pilsen | 32600 | Czechia |
| Investigational Site Number 203102 | Prague | 10000 | Czechia |
| Investigational Site Number 203101 | Prague | 10034 | Czechia |
| Investigational Site Number 203105 | Prague | 12808 | Czechia |
| Investigational Site Number 203103 | Trutnov | 54101 | Czechia |
| Investigational Site Number 203106 | Újezd u Brna | 664 53 | Czechia |
| Investigational Site Number 250108 | Clermont-Ferrand | 63000 | France |
| Investigational Site Number 250102 | Menton | 06500 | France |
| Investigational Site Number 250103 | Nanterre | 92014 | France |
| Investigational Site Number 250105 | Rennes | 35700 | France |
| Investigational Site Number 276103 | Aßlar | 35614 | Germany |
| Investigational Site Number 276102 | Bad Mergentheim | 97980 | Germany |
| Investigational Site Number 276107 | Berlin | 13125 | Germany |
| Investigational Site Number 276101 | Heidelberg | 69115 | Germany |
| Investigational Site Number 276104 | Künzing | 94550 | Germany |
| Investigational Site Number 276105 | Pirna | 01796 | Germany |
| Investigational Site Number 276108 | Saint Ingbert-Oberwürzbach | 66386 | Germany |
| Investigational Site Number 616106 | Bytom | 41-902 | Poland |
| Investigational Site Number 616102 | Gdansk | 80-858 | Poland |
| Investigational Site Number 616101 | Krakow | 31-450 | Poland |
| Investigational Site Number 616103 | Lublin | 20-538 | Poland |
| Investigational Site Number 616108 | Oświęcim | 32-600 | Poland |
| Investigational Site Number 616105 | Wroclaw | 50-127 | Poland |
| Investigational Site Number 616104 | Wroclaw | 50-306 | Poland |
| Investigational Site Number 616107 | Wroclaw | 50-403 | Poland |
| Investigational Site Number 642101 | Bucharest | 050538 | Romania |
| Investigational Site Number 642105 | Oradea | 410169 | Romania |
| Investigational Site Number 642102 | Ploieşti | 100097 | Romania |
| Investigational Site Number 642104 | Reşiţa | 320076 | Romania |
| Investigational Site Number 642103 | Timișoara | 300456 | Romania |
| Investigational Site Number 643103 | Moscow | 119435 | Russia |
| Investigational Site Number 643101 | Moscow | 125367 | Russia |
| Investigational Site Number 643106 | Nizhny Novgorod | 603018 | Russia |
| Investigational Site Number 643107 | Saint Petersburg | 194291 | Russia |
| Investigational Site Number 643105 | Saint Petersburg | 194354 | Russia |
| Investigational Site Number 643110 | Saint Petersburg | 195257 | Russia |
| Investigational Site Number 643102 | Samara | 443067 | Russia |
| Investigational Site Number 643108 | Vladimir | 600023 | Russia |
| Investigational Site Number 643104 | Voronezh | 394018 | Russia |
| Investigational Site Number 724107 | A Coruña | 15006 | Spain |
| Investigational Site Number 724104 | Barcelona | 08020 | Spain |
| Investigational Site Number 724103 | Barcelona | 08041 | Spain |
| Investigational Site Number 724102 | Ferrol | 15403 | Spain |
| Investigational Site Number 724101 | Hostalets de Balenyà | 08550 | Spain |
| Investigational Site Number 724106 | Málaga | 29010 | Spain |
| Investigational Site Number 724108 | Segovia | 40002 | Spain |
| Investigational Site Number 724105 | Seville | 41014 | Spain |
| Investigational Site Number 804108 | Kharkiv | 61002 | Ukraine |
| Investigational Site Number 804105 | Kharkiv | 61022 | Ukraine |
| Investigational Site Number 804102 | Kiev | 2091 | Ukraine |
| Investigational Site Number 804103 | Kyiv | 04114 | Ukraine |
| Investigational Site Number 804104 | Mykolaiv | 54003 | Ukraine |
| Investigational Site Number 804106 | Poltava | 36011 | Ukraine |
| Investigational Site Number 804101 | Zaporozhie | 69600 | Ukraine |
Lixisenatide 10 mcg SC injection QD within 1 hour before "breakfast" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lixisenatide Main Meal | Lixisenatide 10 mcg SC injection QD within 1 hour before "main meal of the day" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin. |
| BG001 | Lixisenatide Breakfast | Lixisenatide 10 mcg SC injection QD within 1 hour before "breakfast" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin. |
| 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 | Number | participants |
| ||||||||||||||||
| Ethnicity | Number | participants |
| ||||||||||||||||
| Number of Participants with Categorical Body Mass Index (BMI) | Number | participants |
| ||||||||||||||||
| BMI, Continuous | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| HbA1c | Mean | Standard Deviation | Percentage of hemoglobin |
| |||||||||||||||
| Fasting Plasma Glucose (FPG) | N=225, 225 | Mean | Standard Deviation | mmol/L |
| ||||||||||||||
| Average 7-point Self-monitored Plasma Glucose (SMPG) | N=211, 207 | Mean | Standard Deviation | mmol/L |
| ||||||||||||||
| Duration of Diabetes | Mean | Standard Deviation | years |
| |||||||||||||||
| Metformin Daily Dose | Mean | Standard Deviation | mg |
| |||||||||||||||
| Randomization Strata of Main Meal of the Day | 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 | Change in HbA1c From Baseline to Week 24 | Change in HbA1C was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period. | Modified intent-to-treat (mITT) population: all randomized participants who received at least one dose of study drug and had both baseline and at least one post-baseline assessment of any primary or secondary efficacy endpoints, irrespective of compliance with study protocol and procedures. | Posted | Least Squares Mean | Standard Error | Percentage of hemoglobin | Baseline, Week 24 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HbA1c Level <7 % or ≤6.5% at Week 24 | Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period. | mITT population. | Posted | Number | Percentage of participants | Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Average 7-point SMPG Profiles From Baseline to Week 24 | Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime two times in a week before baseline, before visit Week 8, before visit Week 12 and before visit week 24. The average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period. | mITT population. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 24 |
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| Secondary | Change in FPG From Baseline to Week 24 | Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment during on-treatment period. | mITT population. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 24 |
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| Secondary | Change in Body Weight From Baseline to Week 24 | Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period. | mITT population. | Posted | Least Squares Mean | Standard Error | kg | Baseline, Week 24 |
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| Secondary | Percentage of Participants Who Reached the Target of HbA1c <7% at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (Plasma Glucose [PG] <60 mg/dL [3.3 mmol/L]) During 24-Week Treatment Period | Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemic episode with an accompanying PG<60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate if no PG measurement was available. On-treatment period for symptomatic hypoglycemia assessment was defined as time from first dose of study drug up to 1 day after last dose of study drug. Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one symptomatic hypoglycemia. Otherwise, they were counted as missing. | mITT population. | Posted | Number | Percentage of participants | Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24 | Participants without post-baseline on-treatment values for (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing. | mITT population. | Posted | Number | Percentage of participants | Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (PG<60 mg/dL [3.3 mmol/L]) During the 24-Week Treatment Period | Participants without post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart not more than 30-days apart were counted as non-responders if at least one of components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing. | mITT population. | Posted | Number | Percentage of participants | Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Reached the Target of HbA1c <7% And Had a 2-hour Postprandial Plasma Glucose (PPG) <140mg/dL After Breakfast or Main Meal At Week 24 | On-treatment period for 2-hour PPG assessment was defined as the time from the first dose of study drug up to the day of last dose of study drug. Participants without post-baseline on-treatment values (for HbA1c and 2-hour PPG) that were no more than 30-days apart were counted as non-responders if at least one of the components (HbA1cand/or 2-hour PPG) was available and showed no response. Otherwise, they were counted as missing. | mITT population. | Posted | Number | Percentage of participants | Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Diabetes Treatment Satisfaction Questionnaire Score (DTSQs) From Baseline to Week 24 | DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1, 4, 5, 6, 7 and 8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. On-treatment period for treatment satisfaction assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Missing data was imputed using LOCF. Here, number of participants analyzed = participants with both baseline and Week 24 DTSQ score assessment during on-treatment period. | mITT population. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 24 |
|
All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 171) regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the first dose of study drug up to 3 days after the last dose of study drug). Safety population defined as all randomized participants who received at least one dose of study drug.
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 Main Meal | Lixisenatide 10 mcg SC injection QD within 1 hour before "main meal of the day" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin. | 7 | 225 | 65 | 225 | ||
| EG001 | Lixisenatide Breakfast | Lixisenatide 10 mcg SC injection QD within 1 hour before "breakfast" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin. | 7 | 226 | 60 | 226 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal strangulated hernia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | 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 |
| D004333 | Drug Administration Routes |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
| Black |
|
| Asian/Oriental |
|
| Non-Hispanic |
|
| ≥30 kg/m^2 |
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| Lunch |
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| Dinner |
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| Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c (<8.0%, ≥8.0%), randomization strata of main meal of the day and country as fixed effects and baseline HbA1c value as a covariate. A step-down procedure was used to control the type I error. The superiority was assessed by comparing the p-value at significance level = 0.05. | ANCOVA | 0.2664 | Threshold for significance at 0.05 level. | LS Mean Difference | 0.09 | Standard Error of the Mean | 0.079 | 2-Sided | Lixisenatide Main Meal vs Lixisenatide Breakfast | No | Superiority or Other |
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